All right, we can get started. Good morning, everyone. Welcome to Harrow's inaugural Investor and Analyst Day. My name is Mike Biega. I am the Vice President of Investor Relations and Communications, and we're thrilled to be here with all of you today. The company's remarks may include forward-looking statements within the meanings of federal securities law. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harrow's control, including risks and uncertainties ascribed from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technologies, and FDA approval of certain drug candidates in a timely manner or at all.
For a list and description of those risks and uncertainties, please see the risk factor section of the company's most recent annual report on Form 10-K and subsequent quarterly earning reports on Form 10-Q filed with the Securities and Exchange Commission. We have a very full agenda planned for today. We'll start with about two and a half to three hours of prepared remarks, followed by roughly 30 minutes of questions. I do kindly ask that you hold all of your questions until after the presentations, and then when we reach this Q&A session, raise your hand. I'll come around with the microphone and hand it to you. Once you have the mic, please ask your question.
As you have noticed, we don't have any formal breaks built into the agenda, but we do have lunch out and back, as well as specialty coffee carts, so please help yourself whenever you wish. Today, we have several members of the Harrow leadership team here today. Joining me today are Mark L. Baum, Chief Executive Officer, Chairman of the Board and Founder, Andrew Boll, President, Chief Financial Officer and Founder, Amir Shojai, Chief Scientific Officer, Prashanth Anna Vajjala, Chief of Staff to Mark L. Baum, John Saharik, CEO of ImprimisRx, Pat Sullivan, Head of Commercial, Chad Bryants, Vice President of our Surgical Portfolio, Allie Harrison, Vice President of our Retina Portfolio, and Maria Lloyd, Vice President of Dry Eye.
On behalf of the entire Harrow family, I would like to sincerely thank all of the renowned thought leaders that took time out of their busy schedules to join us today. We truly appreciate it. Each of these speakers will be formally introduced at the time of the presentation. Joining today is Larry Delahaye, sorry Larry, Maggie Jeffries, Tal Karpeki, Raj Patel, and Sinuhe Prasad. With that, I would now like to turn it over to our CEO, Mark.
There you go, buddy.
Thank you. On behalf of the entire 400-plus strong Harrow family, please know how grateful we are for your audience today, truly. I want to especially thank Mike Biega for putting this event on. It's an incredible day for our company, so thank you. Great job, Mike. In 1945 in Fort Worth, Texas, Robert Alexander and William Connor founded a small company called Alcon. Over time, it has grown into the world's leading ophthalmic business. Just three years later, in 1948, Gavin S. Herbert founded Allergan, which became one of the most important ophthalmic businesses in the world. These two stories of Alcon and Allergan remind us of the power of entrepreneurial vision. The truth is that it's been more than 77 years since we've seen a great founder-led U.S. ophthalmic business emerge. At Harrow, our vision is simple: to become the next great U.S. ophthalmic company.
With only $1 million of invested capital and a trillion dollars of determination, we've built Harrow, which now owns the largest and most diversified portfolio of prescription ophthalmic products in the North American market. Harrow's success rests on four pillars. First, we're founder-led. Andrew and I are highly motivated by our equity, and we're 100% aligned with our stockholders. We've personally directed every aspect of our growth from building Imprimis from scratch to the last five years of acquiring about 17 branded products from companies across the globe. Second, our growing and profitable base business has been consistently fueled because Harrow is now the most active partner of choice in the ophthalmic M&A market, acquiring great assets at attractive prices, including the one that we announced this morning. Third, we have incredible people that we work with, and they are executing.
Harrow is not a place to come to work if you want to take it easy. It's a demanding, merit-based environment, which isn't for everyone. I never cap compensation because I never want to cap the level of effort and the value that our members of the Harrow family bring to the company. Finally, fourth, while we love what we have, the future is white hot, bright, with multiple new and exciting product launches on deck, as well as NDA filings for large market opportunities coming in the fairly near term. In Q4, TRIESENCE in ophthalmic surgery, next year, BICLOVI and BioViz, the following year, Opuviz and Melt 300, and who knows what else we have up on our sleeves next. Harrow's purpose is clear. We're in the ophthalmic disease management solutions business.
Our products are not only safe and effective, but they're accessible and affordable to those who need them. They enhance patient compliance and ultimately improve clinical outcomes. Our portfolio covers a wide range of formats and therapeutic areas. We serve the entire spectrum of ophthalmic care, the anterior, posterior, and ocular surface segments. We employ a disciplined acquisition approach. Over the last five years, you've seen us deploy modest amounts of capital to acquire assets that generate sustainable long-term value. We've paired our growth with a stable operating cost structure and a commercial platform that can scale with minimal incremental expenses. That combination, plus focused discipline and efficiency, is how we're building and growing a profitable business that achieves our vision. Here's what the Harrow portfolio currently looks like today, including the therapeutic areas that we cover. Not bad from where we started from.
I'd like to comment on the very exciting news of our agreement to acquire Melt. Melt has the potential to transform not only ophthalmic surgery, but sedation for tens of millions of short-duration procedures. Think about cataract surgery for sure. That is both IV and opioid-free. Did you know that in 2022, a study published in the Journal of Cataract and Refractive Surgery found that in a two-year review of cataract surgery cases at Duke University, opioids were administered in nearly 97% of those procedures? A separate study of ophthalmic procedures at the Mayo Clinic found that fentanyl was used in nearly 80% of cases. Melt will change this. Why stop there? What about dental procedures, vasectomies, derm, plastics, GI procedures, putting in pacemakers? How about women's health and ENT? We believe there may be applications even in veterinary care.
Did you know that about one in four patients who are in an MRI tube have claustrophobia and press the button to get out? We doubt they will if they have a Melt 300. Melt's patented technology is a game changer in these applications and others, and we believe Melt's product candidates are better for doctors, patients, and the healthcare system compared to traditional IV sedation. Here's the key commercially. For ophthalmic applications, Harrow is in a unique position to bring Melt's lead drug candidate, Melt 300, to market because we currently sell a compounded version of the Melt 300. In fact, last year we sold over 150,000 units to more than 700 accounts. We already have the relationships and the commercial infrastructure in place to nearly eliminate the launch risk for the Melt 300.
With an FDA-approved Melt 300, we have a clear path to another $100 million-plus high-margin annual revenue product for our portfolio. We will, at the same time, dramatically improve the surgical experience for millions of Americans each year. Conservatively, we expect to file an NDA in 2027 and launch in 2028. Hopefully, we can beat those dates. You know, building a great company isn't only about the financial results, it's also about celebrating the humanity of what we do. I am proud that we support ophthalmologists and optometrists who bring sight-saving care to people in need on mission trips around the world. We are proud to have never, ever turned down an opportunity to provide Harrow products to ophthalmologists and optometrists who are helping to give the gift of sight to our fellow brothers and sisters in the U.S. and across the globe.
In 2024, our products helped about 17,000 patients in 38 countries. Already this year, in 2025, we've helped over 5,000 patients in 18 countries. From Honduras to Africa to the West Indies to right here at home, Harrow is helping restore vision, change lives, and in turn, fuel our souls as human beings and our purpose as a corporate citizen. When I say Harrow is the next great U.S. ophthalmic company, it's not just a slogan. In reality, we are creating this each and every day. That said, we're going to fail. We're going to get things wrong, and we will learn from our mistakes, as we always have. Over the long term, we have a fairly clear picture of what we can achieve. We have the portfolio to win. We have the platform. We have the pipeline. Melt is another example of how we're building to grow.
Rest assured, we aren't done. We also have the people. Today, I'm excited that you will meet other members of the Harrow leadership team. In conclusion, I hope you'll agree that 77 years after Alcon and Allergan were founded, Harrow is now carrying the torch as the next great founder-led U.S. ophthalmic company. Founders aren't enough. We need the partnership of the Harrow family and, of course, our stockholders. Together, it is a future that is white hot, bright. Thank you.
I always get to follow Mark, and he's such a good speaker. It's always tough. Hey, everyone. Thank you for being here. I appreciate you being here, your trust in Harrow and our team. Today, I'm going to provide an overview of our business development process. I'm going to discuss our recent debt transaction, discuss our revenue history and 2025 guide, and I'll close out by laying out the roadmap for our fourth quarter 2027 revenue goals. Kicking things off with our BD activity. As many of you know, Mark and I lead our BD initiatives. That lets us move quickly, keep quality high, and stay aligned with the long-term value creation. There's a simple framework we use. First, strategic fit. We focus in markets we have a deep domain knowledge and strong conviction, and we prioritize products that complement our existing portfolio. Second, financial discipline.
We take a disciplined risk posture to our deals. We are selective in the processes we take on and use bilateral engagement whenever possible, with the goal of maintaining financial flexibility. Third, product and market profile. Every product must have a clear pathway to payment. We target commercial stage and late-stage products with clear differentiation in a straightforward integration pathway. Fourth, we consider execution and integration. We pick assets that scale efficiently within our infrastructure, and we prioritize low integration risk and quick synergy realization. Finally, long-term value creation. We ask one question: How does this asset enhance our long-term growth trajectory by delivering durable revenue potential? This framework has helped us out with our current portfolio, and we expect it will continue to be an outline we use for future deals to come.
Moving on to our recent debt financing, we're very pleased with the outcome of this refinancing process that took place earlier this month. This transaction strengthens our balance sheet and positions us for the next stage of growth. By refinancing on improved terms, we lowered our cost of capital, which reduces interest expense and improves cash flow. Equally important, the refinancing extends our debt maturity profile, reduces near-term obligation, and improves financial stability. Investors should view this as a signal of our strong credit profile and our ability to secure financing at attractive terms. Importantly, we were able to achieve all three goals we sought for: lower cost of capital, increased flexibility, and improved ability to pursue and close on BD opportunities. Here are some of the details. We issued $250 million of unsecured notes with a five-year maturity and an 8.5% coupon rate.
After paying the underwriters, we refinanced our existing debt stack with the proceeds. We also paid out all accrued interest on the old debt of about $4 million, plus some exit costs. When you include all of that, we netted about $10 million of new cash to the balance sheet. On top of that, we announced a $40 million revolving credit facility that was committed by Fifth Third. This is going to carry an interest rate on drawn funds of SOFR plus 125 basis points to 175 basis points, and an unused line fee of just 25 basis points. Between the revolver and the new cash, we now have $50 million of new liquidity coming out of the refinancing, and our next interest payment isn't going to be due until March of 2026.
Speaking of those interest payments, this refinancing reduced our cash-based interest expense by approximately $3 million a year. Taken all together, these moves improve our capital efficiency, they lower our risk, and position us well to reinvest in growth and pursue attractive BD opportunities. As a framing for our financial policy, Mark and I want to operate the business at under three times gross leverage and under two times net leverage and expect to get there in the short term as we grow into our revenue plans. With the exception of 2021, our growth has exceeded 40% annually over the last five years. What's most compelling is that we remain in the early innings across all our major revenue drivers, which gives us significant runway ahead.
If you focus on the past two years following the launch of some of our key products, you'll notice one clear pattern: the second half of the year delivers stronger results than the first. We anticipate this trend continuing this year in 2025 as we look to hit our guidance of over $280 million of revenue. Last, let me walk you all through the pathway to the medium-term goal of $250 million plus in quarterly revenue by Q4 of 2027 and why we're confident in it. First, we anticipate VEVYE generating about $75 million of quarterly revenue. This is going to be driven by the product's best-in-class attributes: continued new prescription growth and total prescription growth, which we are seeing no signs of slowing down in Q3. This is supported by the product's best-in-class refill rate. We also anticipate gross-to-net improvement upon increased payer coverage for the product.
As supply chain for this product stabilizes and a new manufacturing site comes online, we're going to have the ability, and we will expand the sales team and increase commercialization efforts around this important product. Next, we expect our retina portfolio to contribute roughly $140 million by the fourth quarter of 2027. This is going to be driven by IHEEZO, which is we're going to leverage high reorder rates, clinical synergy with the biosimilars. We saw this in Q2, where we showed a lot of growth in IHEEZO. We don't anticipate that slowing down. TRIESENCE is also gaining momentum in retina, and we are expanding into the ocular inflammation, its largest market, in the fourth quarter of this year. We also plan on launching some important go-to-market initiatives in the fourth quarter that we think will help accelerate growth of this product. Last on the retina side, biosimilars.
These are my favorite. BioViz and Opuviz target a very large market. In fact, it's the largest market within ophthalmology. These products both have interchangeability status with the reference products, and we have key customer relationships already in place. When we launch, we will have a unique strategy in this market, and we think we'll be positioned strong to deliver meaningful results for both products. The next bucket is our surgical, rare, and specialty products, which we expect to deliver over $15 million of revenue in the fourth quarter of 2027. We have BICLOVI launching in the first quarter of next year. This is the first novel topical steroid in the last 15 years to come to market in the ophthalmology space.
We think our Harrow Access for All program, which we announced yesterday, along with limited active competition here, will be to our advantage as we grow unit volumes of most of these products, if not all of them, in addition to the revenue profile of all of the products. As we look past 2027, we're confident Melt will add further growth, assuming a 2028 FDA approval. ImprimisRx is our last bucket here. This is our most mature business. It's where we started the company, and we expect it to remain stable, slow growth, and continue to be a solid contributor of about $20 million of revenue a quarter. Now, we won't get every line right. Some will overperform, some will underperform, but we do see a clear path to these levels with the products we have.
On the profitability side, we expect gross margins to be in the low to mid-80s, depending on the product mix, and operating margins to be in the 30 to 40% range at these revenue levels. Thank you all again for your time today and interest. It's truly an honor to work for you all, and I'll now hand the call off to our next speaker.
All right. Good to see everyone. My name is Amir Shojai. I'm the Chief Scientific Officer here at Harrow, and I'm going to walk you through some things that I don't think you've seen before, and that's mainly our pipeline products. There's a little background on me. From a pipeline perspective, what I want to walk you through a little bit is what's our philosophy and how do we actually select products to put into our pipeline and where or how do we approach clinical development. Generally speaking, we look for de-risked approaches, and we look for probability of success to be high, both in clin-reg areas. De-risk in way of availability of data where we would not have to worry about clinical likelihood of success or regulatory likelihood of approval. Andrew already pointed this out.
From a capital investment, we are very structured and disciplined, so we would want to be capital efficient in developing our products, and also we use a shared risk model. That said, we actually have specific milestones that have to be set in advance before we lay more in way of capital input. These are three key pipeline products that I'm going to quickly review for you. One of the things that's important is we have organic growth of pipeline where it's mostly internally built, and then we also have inorganic where we actually have partnership with external collaborators, so you'll see a combination of that here. With respect to Melt program, you've already heard the announcement this morning, as well as the talk that both Mark and Andrew provided. This is a very unique opportunity. It is indicated, will be indicated for procedural sedation.
The anticipated filing will be in 2027, and the launch will be in 2028. The other program is prefilled syringe of TRIESENCE. This is triamcinolone. We call it, from a coding perspective, HNO8. This is a product that's going to have the same exact label as the current TRIESENCE. However, it will come in customer-friendly presentation of it in a prefilled syringe. Why this is a unique product is also the fact that we will have a much more robust manufacturing in CMC, so the production of the product will be a lot more enhanced. That said, we anticipate an availability of that product in 2028. The last program that I have on here is called CR01. It's a conjunctival delivery device. This is pretty unique. I'll go over it in a second, but this is for a specific ocular cancer indication that is a rare indication by itself.
Currently, the stage of this program is in proof of concept study, which will be in cancer patients. We anticipate that program, if the data prevail, to be in a launch mode in 2029. One of the things I want to talk about is Melt. You'll hear a lot more on it from Larry, but the way we talk about de-risked asset, this is a classic example. You'll see that the FDA already had an agreement with the company with respect to what that phase three should look like and what's the likelihood of success if you do hit it. They had a special protocol assessment in place where the design, the planned analysis, the statistical approach, all of them were agreed upon, and the company executed accordingly. In November, you heard that, or you've seen the results where they've hit both primary and secondary endpoints.
This already increases the likelihood of success, and from a submittability perspective of an NDA stance, we don't have concerns. Next to do are some ancillary PK studies that we would have to complete, along with obviously compiling an NDA together and submitting. We anticipate all of that to occur in 2027, and the studies will be actually upon closing, but the submission would be in 2027 with approval in 2028, anticipation, as well as launch shortly thereafter. The TRIESENCE program that I mentioned already, this is going to be a brand new NDA. From an overall work perspective, it will be a lot of effort. It will be a lot of CMC work to manufacture the product in a much more robust manner. From a label perspective, we anticipate the same label, the same wide indications that we currently have.
However, we will be bringing it in a prefilled syringe, which is a lot more friendly to the docs. That said, we anticipate to do a pivotal visualization phase three study, as well as a PK study. This program is slated to actually be in an NDA submission mode by the end of 2027. The CR01, I alluded to this a little bit. This was a collaboration that we sort of got in with getting an option agreement for the full U.S. rights of this asset with Dr. Humayun at USC and Dr. Tai at Caltech. This is really a phenomenal delivery device. The picture is on here for you, but it goes into the lower conjunctival area, and the patient could administer it.
This is not an in-office administration per se, and they've already had a tolerability safety study of this device, so that's already sort of passed the hurdle of testing from our perspective. With that in hand, we're now going to be delivering this chemotherapeutic for a specific kind of ocular cancer. Why we think this delivery device actually meets an unmet need is unique because we think with this prolonged slow release over a period of time, we could actually minimize the anticipated adverse events that the chemotherapeutic already creates. We think in this way of delivery, we have a better shot of increasing compliance overall with treatment and therefore get a better outcome in terms of remission. This is a unique approach.
We are going to have this tested in about a dozen patients ex-U.S., and once that testing is done, we would get to actually see it exclusively from a data perspective and decide on whether we actually exercise our option and go forward. From a timing perspective, we anticipate that to be the first half of next year. From a layout, from a capital perspective, we've only put in $250,000. That's again another example of how we are quite disciplined, both in terms of de-risking assets, in terms of success, but also in our capital layout for spend. With that, I will pass the baton to Larry, and I'm not going to butcher your last name. Here you go, Larry.
Thanks, Amir. Thanks to Mark and Andrew for inviting me to present here. Tell you a little bit about Melt. The correct pronunciation of my last name is Dillahey. There'll be a quiz at the end. What we're working on at Melt is an option to provide an option for both patients and physicians to avoid needles and opioids and procedural sedation. Our lead candidate is Melt 300, it's a fixed dose sublingual tablet of 3 milligrams midazolam, 50 milligrams of ketamine, two well-known molecules to the FDA. We exclusively licensed a technology from Catalent Pharmaceuticals called Zydis. Zydis is already being used in over 35 NDA products. Once it's administered to the sublingual mucosa, it dissolves in three or four seconds. I have placebos in the back. If anyone wants to try it, I promise you they're placebos.
Delivering a drug through the sublingual mucosa allows you to bypass first pass hepatic metabolism. Some people get a little antsy with the ketamine molecule. The good news here is midazolam would be the antidote or the reversal agent to any issues that can be seen with ketamine. We're at a pretty low dose of ketamine. We don't see any of that in our studies anyway. To allay any concerns, midazolam is how they would treat that in a setting, an OR setting. We have a really good patent estate, six issued patents that carry us through 2036. We have ex-U.S. patents in Asia, Australia, Canada, Europe, many of the most of the countries that pharma likes to play in. The initial target audience is cataract surgery. By the time this product launches, there's going to be over 5 million cataract surgeries done each year in the U.S.
and 20 million done worldwide. What I really want to draw your attention to on this slide is the bottom right. Mark touched on this, the label expansion is going to be really important for the product to really see huge upside. There's over 100 million procedures that Melt 300 could be used for. Amir's already touched on this. Before the phase 3 study started, we requested and got agreement on a special protocol assessment that Amir has explained to you. We are thrilled about this. As he said, it takes out some of the conversations that can go back and forth with FDA about, did you do this right? Did you do that right? Those conversations are eliminated. That makes us excited. They agreed that it would adequately address the objectives necessary to support a regulatory filing.
It doesn't guarantee approval, but it does go a long way to helping things out. We also did a thorough QTc study, and they agreed that we didn't alter any cardiac rhythms. This is the phase three study. We ran a phase two study, which was four arms. It also had a ketamine alone arm in there. The results were very similar to what you see here for midazolam. This is the Louise study, I believe we're calling it now. We ran over 500 patients through, and you see that the Melt combination beat both midazolam alone and the placebo alone. The placebo effect is real. It's amazing. A third of patients got through on just placebo, but the placebo effect is very real. We were excited to see these results. This again fulfilled the special protocol assessment. Very favorable safety profile, generally comparable to placebo.
We had no SAEs, severe adverse events, no discontinuations due to adverse events, and no clinically meaningful differences in electrocardiograms, neurocog functions, or vital signs. This product we believe is going to launch into a very favorable reimbursement environment. We believe it's going to achieve and get transitional pass-through, which would make it eligible as a separate payment outside the bundle. There are other products. I think, I know Harrow has one or two products that are doing that, but basically you can charge average selling price plus 6%, and the average selling price has to exceed $510, I believe, is what last year's number was. You do this by requesting and getting a J code under the HCPCS program, and that could drive long-term separate payment in certain medical settings.
If for some reason the J code's not granted, we can also fall back to an S code, which would allow for separate reimbursement as well. I'll introduce Dr. Maggie Jeffries.
Hi, everyone. Thank you so much for having me. I'm coming from Houston, Texas, and the most important thing to understand about who I am is that I'm uniquely positioned as an anesthesiologist who practices almost primarily anesthesia for ophthalmic procedures. That's a little unusual in my field where we usually are multi-specialty or in a hospital or in an ASC doing a lot of different types of surgery. Greater than 80% of my practice is all eye surgery, all day, all the time. I have more of an intimate knowledge of how not only the anesthesia works in an ophthalmic situation, but also the needs of my surgeon. I get feedback from the patients, and I'm kind of uniquely positioned to talk about procedural sedation in the environment in which Melt exists today.
A lot of questions that I get in the medical industry is, why sedation without an IV? Why do we care? Why is this interesting? Why is this different? I always say, why not? Just because we've done something some ways for X number of years doesn't mean there's not a different path forward. There's also a large push to move surgeries. Originally, it was, let's move surgeries to ASCs, ambulatory surgery centers. Now it's, let's move them to the office. CMS is undergoing a large push to move cataract surgery even further into the offices. As they do that, that creates a very unique environment for us to be talking about not putting an IV in. Surgeons' offices don't often staff nurses. They're able to staff cataract surgeries with just OD techs and OAs. These are not places that you're going to want to put an IV in.
It increases their cost burden, and it also can slow them down and also decrease their profitability by having to hire more people to do these. Again, why not? Difficult IVs are also a real thing. It creates delays in surgical systems. That's lower efficiency, and that's money at hand, simply put. Every time I have a difficult IV and more practitioners have to get called and the surgery is delayed, we're just losing money because time is money in an ambulatory surgery center, and the faster we can get patients through. We switch in my practice. Most patients don't get an IV. They get one when it's indicated. If they can get through our surgery without an IV, we can just move them through the system that much faster. Patients really do have IV anxiety, even if they've had a lot in their life.
When they've given a choice, if you look at some data that's out there, they will choose oral or sublingual over IV. They're frequently not given a choice. That's where we come in. We'd like to see that choice be given to patients going forward. There's also frequent and persistent drug shortages for the world of anesthesia and ambulatory surgery centers. I think every month, something we can't get. It's not there. It's unavailable. We've never had a problem with our shortage getting our MKO Melts. The risk is very minimal with an IV, but there's still a risk. We still get infiltrated IVs, large bruising. Patients are on blood thinners. There still is risk, although it is minimal. Opiates are bad. There's tons of data out there. I was part of the consortium that published a large article about opiate use, opiate use disorder in ophthalmic surgeries.
Two of those studies were quoted by Mark that are in our paper as well. It causes damage. The studies out there actually have a one-hit theory that you get opiates one day in your life for one surgery, and you're at risk for opiate use disorder. Imagine cataract surgery patients are here for twice. Like it was said earlier, fentanyl is really used in the anesthesia environment to do procedural sedation. I'd like to see it eliminated for these types of procedures. Why do we use sublingual? Why is it superior to oral? I get asked that a lot. Why not just a pill that you swallow? It's actually an ingenious way to do it. First of all, dysphagia and malabsorption in the stomach is a real problem, especially in patients over the age of 65. We bypass that issue.
It also bypasses what's called the hepatic first pass effect, where when you get a drug IV, it goes to your liver first and is broken down into byproducts. This goes directly into the bloodstream and bypasses that. You could give it nasally, but nasal mucosa actually has kind of a mimicked first pass effect. Sublingual is actually quite superior. It's the most permeable area of the mouth. When you're sublingually absorbing a medication, it's the closest to an IV route that you can get. There's nothing really better. You get a very good concentration of the drug, which the PK studies I have no doubt will show that the amount absorbed is quite close to the amount in the drug itself. Midazolam and ketamine together are an ideal anesthetic. For those that don't know, midazolam is a sedative. It's in the benzodiazepine family. Valium is there. Lorazepam is there.
Ativan is there. They're all one big happy family. I always describe it as they're like cousins to each other. Ketamine is a drug that we've been using in anesthesia since I think it was FDA approved in the late 1960s. It's an amnestic, and it's also an analgesic. It has properties to relieve pain. It also adds to the sedative effect of midazolam. The two of them also have a very similar half-life. What that means is they're going to work together really quickly, and then they're going to disappear out of your system around the same time. You're not going to be left with the effects of one and not the other. Their half-lives coincide really well. When used together, the trend for surgical outcomes is better.
I always like quoting an ophthalmologist I work with: when millimeters count, movement counts, and patients with the midazolam-ketamine combination don't move, and they're awake. The opiates cause things like respiratory depression and all sorts of other issues and nausea and vomiting after surgery that I'm constantly having to combat. These two together don't do any of that. The expansion potential is significant. Most of my use is with ophthalmic procedures, but I do have an arm of my practice that does office-based procedures. I use the Melt all the time in offices. I like my practitioners to think about using it any time they have a procedure that's under an hour, that's in the minimal to moderate pain range, that that is a medication they should be thinking about. If we're obviously doing a multi-hour painful surgery, this isn't the medication for that.
There are millions of procedures out there that it's suited for. Dental is a huge one. We've used it in colonoscopies, upper endoscopies with really good effects for patients who have phobias of general anesthesia, which is also a real thing that patients are afraid of. We use it for patients who are having larger surgeries, who have IV phobia for sedation. The irony of talking today is last night I got called by one of my ENT surgeons about a patient that keeps canceling surgery that really needs to happen on their sinuses because they're so terrified of coming in and getting an IV. What can I do? Sure, bring her in. We'll give her a Melt. She'll be fine. We'll put an IV in, no problem. Just having that ability, none of her other surgery centers had that.
None of the other places that she wanted to take that patient was able to meet that need for that surgeon. I'd like our surgeons to start thinking about, OK, I have patients with different needs. There's a medication out there. Let me take this to a place that uses this medication. The real need for it, and in cosmetic, we use it a lot for late facial lasers. There are laser procedures done on faces every day, all day, everywhere, and they're painful. Right now, the patients are just, you know, suck it up, buttercup. This medication really takes the edge off, and we use this for a lot of our patients undergoing minor facial procedures and oculoplastics like blepharoplasties, operations on lids for droopy eyelids, all of those types of things. MRI, I totally agree. Most patients just need a little bit to get them through.
With that, I will turn it over to Pat Sullivan.
Thank you.
Good afternoon. Great to be with you. My name is Pat Sullivan. I'm the new Head of Commercial at Harrow. I just want to introduce myself, tell you a little bit about me. Good if I grab this. I've been in the industry about 25 years, working across, it spans across large companies, mid-sized, startup organizations. I launched 20 products in the U.S., 20 products with about 60% of my time in the U.S. and about 40% of the time to ex-U.S. I have deep expertise in commercialization, launch planning, growth acceleration, and go-to-market across specialty medicines, rare disease, and complex disease areas. I'm thrilled to be here with you today to talk about the growth prospects that Harrow has in front of us. Our commercial vision is clear, is to become the leading ophthalmic organization in the U.S. and the partner of choice to eye care professionals.
Our strategy is centered on driving sustained growth on a consistent basis. We'll do that by driving value of our expanding portfolio of branded products and being relentlessly focused on improving outcomes in the millions of patients that are out there. Notably, it is early days in our growth journey. There is significant headroom and opportunity for us to continually grow. We're going to do that through our commercial excellence model by focusing on, most importantly, having an agile work and unique model that actually drives value creation in the near term with our current products, as well as other products that we bring in through acquisitions and our R&D side.
This will require us having the best talent in the organization that will redefine the engagement with customers and also, most importantly, drive value on a regular basis across our entire portfolio to support our long-term and our near-term growth. When you hear about patient centricity, you can see this evident by our most recent announcement with our Harrow Access for All program. We are an organization that is very much focused on the idea of every, every patient, every prescription, every single time, because we know that when a doctor can write our product, they can get it. It will lead to a positive experience for patients that get Harrow products. Let's talk about the opportunity that we play in. The opportunities that we are right now currently playing in are large. They are well recognized, but they present significant opportunity.
When you look at the dry eye space, just take a look, 16 million patients, and only 8% of patients are optimally controlled. That presents significant opportunity for innovation. In the retina segment, 20 million patients have retinal procedures a year, and there's over 8 million procedures. This again presents opportunity for reliable supply and innovation. In the surgical space that we're stepping into here in the fourth quarter, we look forward to continual growth, with over 7 million ocular surgeries in the year, and the majority of eye care physicians are trying to manage inflammation, which we can help with.
As we talked about our rare and specialty products, these are a mix of everyday products that are out there that we want to make sure doctors can use where it comes to antibiotics, inflammation, and a host of other areas that present opportunity for patients. The key point here is these areas are well recognized. They are well understood, but there is significant unmet need that presents, and Harrow is well poised to close that gap and drive value and help many eye care professionals and their patients. When you think about our commercial focus going forward, we have four areas of focus. Let's just take a look at the dry eye segment.
Our focus in the near term is driving depth where we've launched with VEVYE and continuing to grow depth among the doctors that have used our products, and then, over time, leverage that experience among our eye care professionals to expand our use in other areas with other physicians and other practices. We have a great team that's working on this that has positive signs in early days. Retina. We know with retina that this is an account-based model where there are roughly about 2,000 accounts that are out there in the country. I think one of the things that is really important, we are employing a strategic account initiative to, one, make sure that our depth of our product goes across all of our accounts, our products are available, and that we are getting ready for our next phase of our portfolio with BioViz and Opuviz.
The surgical area, which we are calling a perioperative solution, we are very excited about this as we step forward. That has great prospects for growth. You'll hear more about this from Chad going forward. We have an opportunity and a portfolio that's emerging that will really surround that perioperative experience. That is really valuable because we know that at all of those stages, there are distinct choices that are made. Harrow can be a tremendous solution there. We are, again, this area exists. We are stepping into an area that has a low risk, and we're calling it a displacement strategy that ultimately we step in. We can assume a solution mindset. Our rare and specialty products, what's really exciting about our rare and specialty products is these are well recognized products.
With our Harrow Access for All program and our strategies taking place at the end of 2025 and to start 2026, it is poised for growth for these everyday medications to make sure that the healthcare community can get these products. In closing, we are at an exciting point in our journey. We are very confident in our commercial capabilities, our innovation pipeline, our products, and our people to deliver on our commercial ambition. I'm going to pass this over to Maria Lloyd.
Good afternoon. I'm Maria Lloyd. I've been in the eye care space for over a decade. Oh, thank you, Andrew. Appreciate that. I even launched the first cyclosporin back in 2003. I worked in both large corporations and dynamic startups. My proven track record of success navigating complex markets has equipped me to lead this commercial team, making VEVYE the number one dry eye product in the United States. Before diving into VEVYE, I want to take a step back and highlight the entirety of our dry eye portfolio. My role is centered around providing eye care professionals with the tools, resources, and support they need to effectively manage our dry eye portfolio. We know that when providers have access to the right solutions, patients ultimately benefit from better care and better outcomes.
At Harrow, we have built a world-class dry eye sales team, one that is highly trained, deeply knowledgeable, and fully aligned with the needs of the eye care community. The team is not just responsible for driving adoption of VEVYE. Their mission is to be a trusted partner to providers, ensuring that they feel supported and delivering the best possible treatment for patients. By combining a patient-centered access model and a best-in-class commercial organization, we are positioning ourselves to lead in the management of dry eye disease. We have created a sustainable ecosystem that empowers providers to expand patient access and establishes VEVYE as a therapy to be the number one therapy in this category. Our vision is to become the number one cyclosporin-based dry eye prescription in the United States.
While VEVYE remains the primary focus and a significant growth driver for Harrow, we also have two other important medications that physicians rely on for dry eye management and anterior segment inflammation, as you can see on the slide. Flarex is approved for the use of treatment for steroid-responsive inflammatory conditions. Clinical data demonstrates that Flarex resolved ocular surface inflammation rapidly and effectively, with a lower risk of intraocular pressure elevation. Freshkote is a preservative-free eye drop designed to support all layers of the tear film, offering patients relief from dry eye symptoms while also reducing further irritation. More specifically, Freshkote addresses evaporation, stabilizing all three layers of the tear film, aiming to reduce tear evaporation, lubricating the ocular surface, and also drawing excess water from epithelial cells. Now on to VEVYE. VEVYE truly differentiates itself from other therapies used in dry eye disease. Why?
It is the first and only water-free cyclosporin approved for both signs and symptoms of dry eye, a distinction that truly sets it apart from all cyclosporin-based therapies. The clinical data is compelling. VEVYE's novel delivery vehicle has been shown to deliver approximately 22 times more cyclosporin into the ocular tissue compared to Restasis. This translates into meaningful patient benefits, rapid onset, durable efficacy, lasting out to 56 weeks, and a well-tolerated safety profile. Nearly all patients report none or only mild instillation pain. This is a critical factor in adherence and, more importantly, long-term use. Look, the market opportunity is significant. Dry eye disease is both highly prevalent and undertreated. While an estimated 37 million Americans live with this condition, only 9 million are currently on prescription therapy.
We believe this treatment gap exists in the market because the market has not had access to a product that's truly effective, safe, and differentiated until now. VEVYE directly addresses key unmet needs in this category, and it's uniquely positioned to expand the treated patient population while actually also capturing market share from existing therapies. We are seeing that today. The market has actually grown over 20% year over year. For Harrow, this represents not only a key growth driver but also a chance to reshape the treatment paradigm in dry eye. I'm not going to take you through every single line on this slide because it's a little bit of an eyesore, but I'll point to this. This is how VEVYE clearly distinguishes itself from the competitors in this class, and it is hands-down tolerability. The data you see here is drawn from each product's respective clinical studies.
While not head-to-head trials, they provide a clear picture of this competitive landscape. What stands out is that most competitive products are associated with meaningful ocular adverse events, most notably burning and stinging upon instillation. Look, these side effects are not trivial. They impact comfort, adherence, and ultimately treatment success. In contrast, VEVYE demonstrates a highly favorable safety and tolerability profile. Nearly all patients report no pain or only mild discomfort during instillation, which we believe is a critical differentiator. This advantage positions VEVYE not only as a more effective treatment but also as a therapy that patients are more likely to adhere to long term. When considering the combination of efficacy, tolerability, and durability, it becomes clear why we view VEVYE as a best-in-class option and a growth driver for Harrow.
One of our most significant milestones this year was the launch of VEVYE Access for All, what we call VAFA, our patient-centric access model for VEVYE. VAFA makes treatment more accessible while streamlining the process for both patients and providers. We have already expanded this program to two additional pharmacy partners. This expansion meaningfully broadened VEVYE's distribution network, ensuring greater geographic reach but also operational efficiency. More importantly, it has significantly increased the proportion of patients who can secure coverage and begin therapy without unnecessary delays. VAFA is more than an access model. It's a strategic growth investment. We're driving stronger uptake, reinforcing our competitive positioning, and ensuring that patients benefit from VEVYE's therapeutic profile. Look, at the end of the day, this validates our vision. Aligning patients' needs with smart access strategies accelerates adoption. It builds brand trust and delivers long-term value for our stakeholders.
I'm very pleased with the success that our team has been able to execute on our primary strategic goal to make VEVYE the number one prescribed cyclosporin therapy in the market. In the second quarter, we took a major step towards this objective, reaching a 7.8% market share, and that was a strong increase of 2.6% from the first quarter in 2025. It marks an important milestone. Why? VEVYE has officially surpassed CEQUA in the U.S. market. Today, we stand as the second most prescribed cyclosporin-based dry eye therapy, and we continue to gain momentum. The progress we've made so far is just the foundation. We are still in early days of executing against our strategy, and the opportunity in front of us remains substantial. More importantly, the momentum we've seen in the third quarter shows no signs of slowing down.
This gives us the confidence and the strength and the sustainability of our trajectory. When we look ahead, we know we're only scratching the surface of what VEVYE's potential can be. Market demand for innovative, effective solutions in dry eye disease continues to expand, and our ability to drive broader access, stronger physician engagement, and increase patient adoption positions us to capture significant market share over time. In short, while we are proud of the results we've delivered so far, we believe that the most impactful growth is still to come. With that, I'd like to introduce Dr. Paul Karpecki to the podium. Paul received his Doctor of Optometry degree at Indiana University and completed his fellowship in medical cornea and refractive surgery in Kansas City in affiliation with the Pennsylvania College of Optometry, which is now called Salus University.
He currently serves as the Clinical Director of Advanced Surface Disease at Kentucky Eye Institute in Lexington, Kentucky. He is one of the most highly sought-after key opinion leaders in optometry and operates one of the top dry eye clinics in the U.S., where he sees patients from all over the world. Paul, thank you for joining us today.
Thank you, Maria. Thank you for the opportunity to be here. Thank you, Harrow, and especially thanks to all of you for being here. There are so many things going on in terms of your world, but I think you've made a wise choice. I think what I'm most proud of here besides my family is just I do think I have the largest ocular surface clinic now in the country. I have over 550 Sjogren's syndrome patients, see about 60 patients a day. I live this every day, and the kind of trends that I get to see, because I'm seeing about 60 a day, seem to follow through many times. I put this first slide up here just simply to kind of say two things. First of all, the fact that there's 3 million glaucoma patients in the U.S. tells us two things.
One, dry eye is estimated to be about 38 million. Just putting things in perspective, and yet glaucoma is a significant part of eye care business. Number two, refractive surgery, contact lens wear, cataract surgery, and digital device use are all major contributors to dry eye disease, and none of them are slowing down. No one thinks that our digital devices are going to slow in any capacity and are a big contributor to evaporative forms and other forms of dry eye disease. Number one reason for contact lens dropout and discontinuation is dry eye disease. We've never gained traction because the number of patients that enter the market is about the same % as those that leave. Everything here is consistent with the world of dry eye and how it impacts everything we do in practice.
Now, symptoms are probably not new to many of you here because you've heard of the kind of common complaints that go into dry eye disease, such as difficulty wearing contacts, which we just talked about. I really want to emphasize not so much the symptoms of dryness and irritated red eyes, itchy eyes, but the impact it has on daily life and why there are so many people looking to get in there. My clinic, I was talking to my staff this week, and they said, yeah, we're booking into nearly February. It's just the demand for dry eye because of all we're talking about will only continue to grow. What I'm fascinated about before I talk about this is that, yes, there are 16.4 million people diagnosed with dry eye in eye care practitioner offices, but there's over 38 million that we estimate to have it.
Even some studies show 44 million that have the disease who are under diagnosing it. The most telling fact is that only about 1.6 million are treated with therapeutics. It's a small percentage. I think Patrick showed the 8%. That's the 1.6 million people. This is why this is so important. It's the reduction in reading capacity, work productivity, difficulty driving at nighttime, blurred vision affecting contact lens dropout, spectacle remakes, IOL miscalculations, and cataract surgery, sensitivity to light, and reduction in sleep quality. If you don't sleep well, you get more dry eye. If you get dry eye, you get more difficulty in sleeping, and it perpetuates over time, resulting in a lot of lost productivity and other issues. It is progressive. That's what makes this disease so important to get on top of and maintain treatment for an extended period of time.
That extended period of time is so critical because we've never been able to do it extremely successfully. We're finally starting to see that changing after many years. I started my first dedicated dry eye clinic 27 years ago. I was trying to figure out when was that first day because I did a one-day working with Danduri in Kansas City that was just dedicated to that. It was 27 years ago at the end of this year. We were limited in what we could do. We had steroids, which we still have, fortunately, today that are critical. We had punctal occlusion. We had artificial tears, and there was really nothing else. Today, you know, we're so lucky. So many of our patients do well, and that's because of all of these advances.
This cycle of inflammation, or the cycle is called a vicious cycle of dry eye disease, is so imperative to understanding what's going on and how we manage this disease. We start often with things like hyperosmolarity. That basically means we have too much salt in our tears, not enough fluid, which is what dry eye by definition is. It could lead, obviously, or it could be caused by evaporation. If you don't have a good oil layer because you use a digital device too much during the day and you don't blink as often, the oil layer actually diminishes, resulting in evaporation for the rest of the layers. That could lead to hyperosmolarity or tear film instability. It could go other ways, too. The arrow could actually go either side. Eventually, that leads to corneal damage we call desiccation. I'll show you a case of that at the end.
All of it triggers inflammation. Inflammation is the hallmark of so much of this disease. The goal today is really to try and focus on, I think, why we're getting it and controlling the inflammation. Sometimes that's devices, sometimes that's therapeutics, and sometimes that's nutritional supplements. They all work together in terms of allowing us to get a hold of this disease and manage it. This is not chapped lips where you can put a little balm on there and hope that everything goes away. This is a true disease that's chronic and affects, as we said, close to 40 million people. Being chronic, it leads to many different forms. There's an aqueous deficient form. The late and great Michael Lemp had a study that showed that's about 14% of the population.
34% of people have both forms of dry eye where their water glands aren't working well, their mucin glands, and the oil glands. The large majority, about 50%, have oil deficiency. We only expect that to increase because of the lifestyle we're in, because of digital devices, because of activities, all the things that take place. You'll notice they all trigger inflammation. There's never a time in my clinic where I'm not managing the inflammation as well as trying to manage the patient's condition at the same time. That's the one component that's consistent amongst all forms of chronic dry eye disease. As I showed you this earlier, the way that we target currently dry eye in terms of clinical practice is through some devices in the office where patients pay to have those done. Artificial tears have been a mainstay, but if you talk to patients, they're limited.
They don't last an extremely long period of time. There's continuing to be a key role. Maria covered Freshcoat today, a very unique drop that works on oncotic pressure and helps in terms of the overall tears to keep that tear layer in place. What's fascinating by that, by artificial tears as a whole, is number one, they're still going to be important to utilize, even though we're going to treat the inflammation. Number two, we're looking for unique ones like that that stand out because there are a group of patients in my clinic that that's the only drop they can typically use. We find those patients in all areas, even therapeutics, where they are responders.
To certain agents, and not to get in the future, but AI is going to help us discover who are those patients ahead of time. For now, we kind of trial them and see where they are. Nutraceuticals still play a role, but our prescription medications are the key. That's where we focus on as clinicians, and how do we manage it from that standpoint, whether it's treating the ocular surface disease, dry eye, blepharitis, et cetera. Those prescription medications combined with others. I think part of the reason our clinic's done well is there's no panacea. There's no magic bullet. You really have to have the best of class, which we're talking about today in cyclosporin hands down, with other things often.
I think our success came from knowing to utilize multiple treatments instead of having a patient come in, trying artificial tears, bringing them back, putting them on hot compresses, bringing them back, putting them on a treatment, bringing them back, putting them on cyclosporin. They don't come back. You really have to start with the fundamentals that we know. What's happened with cyclosporin over the year? What's happened with therapeutics? This actually includes all the therapeutics. I was fortunate to be in both the studies published there as an author or co-author. We analyzed about 9,700 patients out of a database that were on dry eye medications to see how many stayed on their medications for dry eye. These were the more common medications at the time, the cyclosporins that were present and others.
What we discovered was, to some people surprising, that only three people roughly out of 10 stayed on drops. That's a huge dropout rate for a chronic condition without a treatment. These don't suddenly stop because they get better. It's not that type of a disease. It's a case of wondering, why did they not remain on a drop when their disease only continued to progress when they're not utilizing these therapeutics? We discovered a few things kind of stood out. One was tolerability. Patients described it as being difficult to tolerate the drops. Number two, it took too long for the results to happen. They couldn't stay with it. Number three was cost perspective that came into account, depending on access.
It was insightful, but what was really unique about this was just the sheer volume, that seven out of 10 patients that I'm treating and others are treating stopped the medication because it didn't do what they'd hoped to do. That sets the stage for something like VEVYE, where we need a new form of cyclosporin to kind of carry us through there. Because it's not cyclosporin that doesn't work. The agent actually is very effective. In fact, at one point, the original 0.05% cyclosporin had a market peak at over $1.4 billion for the year. Patients did OK on these medications, even though 70% discontinued it. The drug itself, cyclosporin, is very effective. In fact, it works at the heart of dry eye disease, something we call NF-kappa B. That, for me, is the way I put it, as that's the core of inflammation.
When you can control NF-kappa B, you control MMP9, which are enzymes that could damage the surface of the eye, ICAMs that initiate further inflammation. They spring up off the ocular surface, and they can add to more issues around cytokine production, which causes more inflammation, CD147s, which are macrophage activity, MPTP, which leads to cell death. Point being, cyclosporin, which came out in 2003, the very first form of this, has been an effective agent. It's just the differences in the tolerability and long duration is key. We need something in the cyclosporin category that's a first and only. This one really fits three levels of first and only. One is it's approved for signs and symptoms of dry eye disease. Every previous cyclosporin had been approved for increased tear production. Getting signs on there, but more so symptoms, I think, was really a key. Second is water-free.
That means a lot of things. That means there's no preservative. That means there's no pH that could burn or sting. That means there's no osmolarity effects that can cause hypo or hyperosmolarity to the eye. It also dissolves in a semi-fluorinated alkane as far as the cyclosporin in this one. That's another uniqueness that adds another attribute because cyclosporin is not the most soluble agent. It's difficult to get it into the core of the drug. Having a semi-fluorinated alkane seems to be the perfect fit for this drug. That's what we're seeing here. It's called a visual analog scale. Patients come into the trials, and they say, "100 is the worst incapacitating dry eye symptoms I could ever imagine, and 0 is the most comfortable I've ever been." This patient population started at a 70 out of 100. That's pretty significant symptoms.
That's way up there in clinical practice. You can see that within four weeks, that drops, 22% improvement in self-reported discomfort in four weeks. That's a lot. Remember we talked about the reasons the other drops? Seven out of 10 people dropped out of them. This was one of the reasons, because it took too long to work. You've got a 22% significant drop from 70 to 54 as soon as four weeks. That only continued to be a 38% reduction by the time you got to 56 weeks in this patient population. That's the kind of results we want. Not so much the long duration that it continued, because that is important, continued to improve, but also the fact that it had such a significant effect quickly at four weeks. Patient symptoms also improved.
While it's nice to see in my clinic the signs of desiccation improving, and we're seeing numbers like osmolarity improving, ultimately, for most clinicians and for all patients, symptoms are what they look to. This was a factor. If you look at that dropout study, one of the big reasons that went to that 7 out of 10 dropping out was that they didn't see symptoms improving quick enough for what they were doing. These symptoms in the 50-week study, if you took the patients who had three or more grades of improvement in total corneal fluorescein staining, and that's where you look for dry spots on the eye or breakdown areas on the surface called desiccation, those patients saw statistically significant improvement in six out of eight measures of symptoms as soon as day 29.
You can see those there because that included things like awareness of dry eye, reading speeds, digital device use, something we do all the time. You especially do a lot of fluctuating vision, driving at night, et cetera, all impacted in that time. The biggie we talked about, the big issue was that tolerability. Could patients continue on drops if there was a high percentage of burning and stinging or other side effects they had to deal with? This is probably one of the biggest slides I could put up. 99.8% of the clinical trial patients experienced no or mild instillation site pain. I see that in clinical practice.
It is so wonderful to be able to use drops now where I do not have to—I still educate them this can happen, but where I am not dealing with trying to keep them on the drops longer, trying to maintain them because I know the effects they will get if they can stay on their drops. We would rather just prescribe something, see this type of response, and know the medication is going to do what the last slide showed. I will leave you with a good example. Actually, this case is not one of mine. This is for a colleague of mine in Kentucky, a good friend, Dr. Ben Gaddy, who sent in a patient, a 56-year-old white female. This was at the very beginning.
At the very beginning, you are taking patients where they have tried everything else. That is just naturally what you do when a new drug comes out. This would have been back a couple of years now, a year and a half. What we are looking at is this patient who had been on all other medications, preservative-free lubricant eye drops, currently on flaxseed oil, which is nutritional, fluconazole, which is, of course, a spray for allergies through the nose, preservative-free lubricating ointments at nighttime. You can see the vision is not great. 20/25, it is not quite stable when you get numbers like that. She has a lot of symptoms. When you get a score of 21 out of 28 on a speed, that is about as high as they get. It is very hard to get beyond 20s in this type of a questionnaire before going in.
A highly symptomatic patient presenting with a lot of treatments that did not work. If you look to your left, that brighter green are the dry eye spots. They are called desiccative stress or desiccation or breakdown on the surface. We put fluorescein in. We can light them up. Those are our dry spots we look for. If they get really advanced, they become what we call confluent. They kind of coagulate together. They connect together the dots individually. You can see that even though the patient could correct to 20/20, it was not good quality. That is the hallmark of dry eye disease. The patients who say, "If I blink, maybe I could see a little bit better. I have got pretty good vision when I test, but I really do not see all that well.
I cannot drive at night like I used to." The quality of vision is affected. This patient not only was able to completely be rid of the staining pattern, which is difficult to do. Typically, I often have to use steroids. Flarex is an ideal steroid for dry eye disease, especially those with mucin-deficient components of dry eye. Those types of steroids do extremely well. We never thought of maybe an immunomodulator like VEVYE doing that. Most times, I'll have to use both, but in terms of the patient presentation, this one is purely just VEVYE and at one month. Not only did the patient's desiccative signs go away, they got back into contact lens wear, the number one reason for dropout we talked about early. If you look at the other eye beforehand, you can see, again, good vision on testing, but not good quality.
Look at the difference at one month being on VEVYE twice a day. This patient now could resume contact lens wear. It's an exciting drug to get to talk about. It's one that's made a huge difference in my clinical practice. When I was invited, I was honored to be able to present on it and to be able to show the clinical signs to understand where the history has taken us and to look at where now we're going in the future and the impact it'll have on our patients. With that, I'm going to bring up our Chief of Staff to the CEO to come and present next.
Thank you all for being here today. It's great to see such a strong turnout. My name is Prashant Anavajila, and I serve as Chief of Staff to our CEO, Mark L. Baum. While I'm a physician by training and come from a family of ophthalmologists in my native India, I've always gravitated towards the business side of health care, which led me to complete my MBA at Rice University in Houston. I now have over a decade of experience in market access, health care strategy, product commercialization within the pharmaceutical industry, with a particular focus on ophthalmology. Over my career, I've led product launches, shaped market strategies, and driven cross-functional initiatives at organizations such as Regeneron and NVenture. In addition to working closely with Mark on various initiatives, I'm passionate about developing strategies that unlock growth and enhance patient access. I'm excited to bring my perspective into today's discussion.
As I have played a key role in shaping our VEVYE Access for All, our VAFA program, I'd like to share how that works. We've partnered with two specialty pharmacies, Philarx and Apollo Care, who currently support VEVYE Access for All. Importantly, we remain flexible and agnostic to the number of pharmacy partners we work with, provided they align with our business and economic rules. Think of the program like a funnel. When a patient is prescribed VEVYE, their prescription is routed either through Philarx or Apollo Care. From there, the pharmacy determines whether the patient is covered by insurance. If the first pharmacy, in this case, Phil, is unable to secure coverage, we can seamlessly redirect the patient to the other pharmacy, maximizing the number of patients who ultimately gain coverage.
At the bottom of the funnel, if coverage is still not secured, eligible patients can access VEVYE through a simple, affordable cash pay option of just $59. This approach ensures that every patient who has been prescribed VEVYE has a clear, accessible path to treatment, whether through insurance or affordable cash pay. The key to success is ensuring both prescribers and patients have the best possible experience. We achieve this by working with Harrow pharmacy partners and their networks, which follow VEVYE Access for All business rules. As the coverage expands, more VEVYE prescriptions will be filled at a premium pricing, extending to all refills and driving growth in net price per product. Building on the success of VAFA, we were excited to announce yesterday our new Harrow Access for All, or HAFA, initiative.
I've been deeply involved with Mark in shaping this patient-centric access strategy, and I'm thrilled to walk you through it today. The vision of Harrow Access for All is to unify our branded, generic, and compounded ophthalmic medications under a single user-friendly platform. Our exclusive partner in this program is Philarx. For prescribers, Harrow Access for All provides a seamless one-stop solution, essentially the Amazon of ophthalmology, where they can access the full range of therapies they need at affordable prices without friction. Through this program, eligible commercial patients may pay as little as $0, with a maximum out-of-pocket cost of $59 across our entire portfolio. Mark's vision was very clear: ensure patient access to affordable medications while maintaining a reasonable, attractive profit for shareholders. Harrow Access for All will launch in three phases.
Phase one is in the fourth quarter of this year, covers most of the specialty portfolio, and eligible patients pay anywhere between $0 to $59. Phase two will be the first half of 2026, where Harrow generics would be added at the same pricing, which would improve adherence and market capture. Phase three would be in 2027, which would expand to our full portfolio, which includes specialty, generic, and compounded, creating a fully integrated access platform with durable competitive advantage. The Harrow Access for All portal is more than a market access program. It's an ecosystem that expands market presence, drives recurring revenue, and deepens relationships with physicians and patients. Beyond revenue, the true advantage is the service. Harrow Access for All provides physicians a single integrated solution to manage prescriptions, refills, order tracking, and patient needs.
The white glove experience reduces administrative burden, strengthens physician loyalty, improves patient satisfaction, and positions Harrow as the trusted partner across the prescribing journey. To close, VAFA delivered a 66% increase in prescription volume in its first quarter, with nearly every prescription being profitable, a dramatic improvement from pre-VAFA performance. This proof of concept gives us confidence that HAFA will follow a similar trajectory, driving faster adoption of our products and expanding Harrow's share across the portfolio. Most importantly, VAFA and HAFA ensure that nearly every script is profitable, fundamentally strengthening our economics and positioning Harrow for sustained, profitable revenue growth. We expect to see the initial impact of HAFA in the first half of 2026. With that, I'd like to turn over to Chad Bryants, our VP of Surgical Portfolio.
Good afternoon, everyone. Thank you, Patrick. I'm absolutely thrilled to be here today. I recently joined Harrow as Vice President of the Surgical Portfolio. My charge was clear: delight ophthalmologists with our suite of perioperative disease management solutions and build a dominant presence in this important market. It would normally be pretty intimidating to be in a room full of this many savvy, intelligent analysts, key opinion leaders, and just amazing professionals. Exactly two weeks from today, I'll be delivering a speech at the wedding of my youngest daughter. It already chokes me up just saying that. In comparison, this is actually pretty low pressure. Quite frankly, there is much less chance of me crying today, although we'll wait and see how the Q&A session goes before we have that full conclusion.
I'm excited to bring more than 20 years of experience in the medical device and pharmaceutical industries, with leadership roles at Novartis, Stryker, and Johnson & Johnson. In fact, most of my career has been in some form of a surgical area. Most recently, during my time at Ocular Therapeutics, I led the successful execution of the go-to-market strategy for Dextenza, a post-ocular surgery steroid. At Harrow, while recruiting the ocular surgery team, I am frequently asked why I joined the company. The answer is simple: to build something great, a great team, a great franchise, and a great company, all of which is enabled by the entrepreneurial spirit of the company, its founders, and the focus on innovation and accessible and affordable eye care solutions. Look no further than this morning's announcement. My immediate priorities are clear. Number one, expanding TRIESENCE into the ocular inflammation market, starting in Q4.
Number two, driving the launch of BICLOVI in the first quarter of next year. Let's start with the opportunity. The ocular surgery market is one of the largest and fastest-growing segments in the entire eye care industry. Each year, more than 7 million ocular surgeries are performed in the United States alone. Of those, cataract surgery procedures represent the vast majority, over 5 million cases annually. In the ocular surgery market, a large focus of our efforts will be on the cataract surgery segment. The growth in this segment is driven by aging demographics, the rising prevalence of vision-impaired conditions, and innovations in surgical techniques, including minimally invasive glaucoma surgery, intraocular lenses, and advanced laser platforms. Harrow is uniquely positioned in this environment. We are strategically focused on delivering a robust and differentiated portfolio of medications that serve the surgical continuum before, during, and after procedures.
This isn't just about individual products. It's about delivering comprehensive solutions for our customers, surgeons, practices, and patients in one of the most critical areas in ophthalmology. As we have built a world-class surgical portfolio, I would like to highlight the focus of our strategy. The main priority is clear: to successfully launch and establish TRIESENCE, BICLOVI, and eventually the recently acquired Melt 300. These three products form the backbone of our surgical portfolio. They represent differentiated solutions that meet the pressing needs of physicians and patients and will be the central focus of our commercial execution over the next several years. At the same time, we are ensuring that we maximize the value of our complementary portfolio, including products such as ELEVRO and Nevanac.
While not the core drivers, these assets are strategically important because they complement our primary launches and allow us to deliver a more complete and robust offering to surgical practices. By providing physicians with a broader toolkit, we deepen relationships and strengthen Harrow's position as a trusted partner. The combination of products supports a balanced strategy, one that builds immediate momentum with BICLOVI and TRIESENCE, while sustaining long-term growth and differentiation with a comprehensive portfolio. As I mentioned at the outset, our goal is to provide physicians with a comprehensive perioperative solution for the surgery market. Let's take cataract surgery as an example. A patient must go through several steps for a successful procedure. First, the patient needs sedation. Here, we can offer Melt 300, a non-IV, non-opioid option.
Next, after surgery, inflammation must be managed, and physicians have a choice between BICLOVI and TRIESENCE, depending on whether they prefer a topical or injectable steroid. We also have ELEVRO and Nevanac should they prefer an NSAID as well. By integrating these solutions, we're making Harrow an essential partner across the full surgical journey. Ocular inflammation resulting from surgery represents the single largest market opportunity for TRIESENCE. In the United States alone, based on procedure volume, cataract surgery remains the most frequently performed surgical intervention each year. The number of cataract surgeries in the United States is projected to increase to nearly 6 million annually by 2030, driven by demographic trends and advances in surgical techniques. I am truly excited about this expansion, with a clear focus on positioning TRIESENCE as a first-line treatment for ocular inflammation in patients who do not respond adequately to topical steroids.
Unlike many alternatives, TRIESENCE is FDA-approved, fully on-label, and preservative-free, providing a safe and effective option that physicians can trust. Equally important, TRIESENCE offers compelling economic advantages. It is the most affordable FDA-approved injectable ocular steroid, with patient out-of-pocket costs as low as $37 under both government and private insurance plans. Coverage is exceptionally strong, with 96% of patients already covered and only 6% of those requiring a prior authorization. Moreover, TRIESENCE is reimbursed across all traditional care settings, ensuring broad accessibility. From a clinical standpoint, TRIESENCE eliminates the challenges associated with steroid eye drops. There's no need for patients or caregivers to administer multiple daily doses, which improves compliance, reduces the risk of complications, and ultimately lowers the overall postoperative burden. This combination of clinical benefit, affordability, and broad access positions TRIESENCE as a differentiated and highly valuable treatment option in ocular inflammation. Now let's turn to BICLOVI.
This is the first novel FDA-approved steroid to enter the U.S. market in more than 15 years. 15 years. It represents a major advancement in post-surgical ocular care. Approved to treat inflammation and pain following surgery, BICLOVI offers a differentiated solution for both physicians and patients. Aside from its unique and patented delivery vehicle, what sets BICLOVI apart is its use of clobetasol, making it the only ocular steroid to harness this highly potent molecule. As a result, BICLOVI is the most powerful steroid on the market, yet it has demonstrated an impressive safety profile in clinical studies, with a low incidence of intraocular pressure elevation and outcomes comparable to placebo. This rare combination of potency and safety provides physicians and surgeons with a tool they have been long waiting for. BICLOVI also offers patient-friendly b.i.d. dosing for only two weeks.
We are preparing to launch BICLOVI in the first quarter of 2026, and my current focus is on executing all key pre-launch activities to ensure a strong and successful introduction. With more than 7 million ophthalmic surgeries performed annually in the U.S., a number that continues to grow, we see a substantial market opportunity ahead, and we are confident BICLOVI is well positioned to capture meaningful share in this large and expanding segment. Execution will be critical, and we are investing accordingly. The first phase of recruitment is complete, and we are ready to take root in the fourth quarter, with the expectation of being fully mobilized in early 2026. In addition to being asked why I joined Harrow, I'm regularly asked by candidates, what's the vision for the surgical team? Where is this franchise going within Harrow?
I like to paint the picture that 12, 18, 24 months from now, when an ocular surgeon has a need for a pharmaceutical product related to surgery, the first company they think of is Harrow, and the first person they think of is their Harrow Ocular Surgery Account Manager. Quite simply, we will become the Amazon of ocular surgery pharmaceuticals. This begins with the expansion of TRIESENCE into ocular inflammation in Q4 of this year, and we anticipate seeing the initial impact in early 2026. Layered on top of that, the launch of BICLOVI is expected in the first quarter of next year. With experienced leadership and a laser focus on this branded surgical portfolio, combined with a specialized, highly experienced all-star commercial team, we will have the right foundation to drive adoption and revenue growth.
We expect the impact of these efforts to be visible in the first half of next year, setting the stage for durable growth in the years ahead. In summary, Harrow's commercial surgical build-out ensures that our innovative products reach the patients who need them. Thank you. Please welcome to the stage Allie Harrison, VP of our Retina Portfolio.
Thanks, Chad. Thanks for giving me the opportunity to speak today, Andrew and Mark. My name is Allie Harrison, and I am the VP of the Retina Portfolio for Harrow. I'm really excited to be here today to talk to you about some of the things that we're going to be building out in the Retina franchise with Harrow, some of my experience. What I want to get into is the meat of why we're here and what I'm going to be talking about today. Let's begin with the big picture with Harrow. Harrow right now is redefining retina care by building out the largest and most comprehensive portfolio in the market. Retina disorders like macular degeneration, diabetic retinopathy, DME represent millions of patients worldwide and represent one of the largest areas in ophthalmology in the U.S.
Our strategy is straightforward: empower physicians with the tools they need and expand access for patients who depend on vision-saving treatments. The infrastructure that we've built is also very unique. It's not just about a single product, but about a platform that's designed to continuously fuel acquisitions, launches, and innovation in the retina space. We are prepared and ready for what Mark and Andrew bring to the table. Perhaps most importantly, though, this strategy is being executed by what I would call the best team in retina, and I think our physicians would agree. We're ready to take on what we're going to be bringing on, and that level of expertise means that we can anticipate physician needs. We can navigate complex reimbursement situations and bring solutions to the table that are clinically meaningful, commercially scalable, and really coming to the table with a problem that's being solved.
Harrow is not just investing in products. We are investing in the future of retina care. Innovation in retina is not just about products. It's also about patient access, which is extremely important in our world. Earlier this year, we launched our Harrow Cares Hub in partnership with Syncora. This hub is a one-stop reimbursement and patient support platform that ensures practices feel confident in prescribing our products. It handles benefit verification, patient copay assistance, prior authorization navigation, and denial support. For physicians, this removes the administrative burdens and barriers that often discourage adoption of new therapies. For patients, it means greater access and affordability. The impact is significant. Instead of being limited to the Medicare fee-for-service patient population, this allows us to expand into the commercial and MedAdvantage patient population.
This means that every patient now that is getting in need of a retinal procedure is now able to get access to our products. IHEEZO is a perfect example of what we're doing in retina and innovation. We are the first branded ocular anesthetic in the U.S. in nearly 14 years. It addresses over 12 million ocular procedures annually. What makes IHEEZO unique? First of all, it acts rapidly within 90 seconds and lasts about 22 minutes. Patients experience less pain scores than tetracaine, and that's a very important differentiator for physicians. It provides sufficient anesthesia throughout the entire procedure, so they don't need supplemental anesthesia. Finally, it is the only reimbursed product of ocular anesthetic on the U.S. market. IHEEZO's intellectual property is also very strong.
It has two patents in the Orange Book that go through 2039, and taken together, these attributes position IHEEZO not just as an alternative, but a standard of care for ocular surface anesthesia for years to come. Mark has asked me whether or not we can capture 10% of the market over the next couple of years, and I believe, although no result can be guaranteed, with the team that we have in place, we can hit that target. Shifting to our commercial focus in 2024, we announced the Retina Pivot, where we focused our efforts on the retina community and the physicians doing intravitreal injections. This was the right pivot. The majority of new accounts that we're seeing coming into Harrow right now are retina-based practices that are implementing IHEEZO across their practice.
We now have agreements in place with all four of our GPOs, group purchasing organizations that service the retina community. Earlier this year, we also announced the IHEEZO Access for All. This is a strategy to drive physician education, accelerate IHEEZO adoption, expanding its use across all retina procedures in both established and new accounts. On top of that, IHEEZO has 92% coverage across both commercial and government payers, which is remarkable for a product only a few years post-launch. The small remainder of claims are either not covered or require prior authorization. We are actively addressing those issues. For practices, the benefits are clear: a standardized, efficient anesthetic protocol that reduces time per procedure, lowers staffing demands, and empowers throughput. Finally, our biosimilars portfolio creates powerful clinical and economic synergies with IHEEZO.
Every intravitreal injection requires a topical anesthetic, and that makes IHEEZO an essential and wonderful complement to biosimilars like BioViz and OPUViz. As these biosimilars launch, we expect to be a catalyst for the further adoption of IHEEZO. The value extends beyond the clinical setting. Together, these products drive efficiency, reduce procedure costs, and create scalable economic benefits for practices. In short, IHEEZO is not only a best-in-class anesthetic, it's also a growth engine and a better business solution for retina specialists. I think you're all aware that the backbone in the retina space for treatment is the anti-VEGF market. Harrow is well positioned for two best-in-class biosimilars. We recently entered into an agreement with Samsung Bioepis, a global leader in biosimilar development, to acquire the U.S. commercial rights to both BioViz and OPUViz. BioViz, the first FDA-approved Lucentis biosimilar, is on track for U.S. launch in mid-2026.
OPUViz and Eylea biosimilars are expected to launch in the second half of 2027. Both products carry interchangeability status, giving them a critical commercial advantage. What makes these assets so attractive is how they complement our existing portfolio. They integrate seamlessly into our commercial infrastructure, aligning clinically with IHEEZO and TRIESENCE. Together, they create a holistic offering that few, if any, of our competitors can match. Let's take a closer look at BioViz. In 2024, Lucentis accounted for approximately 680,000 units, and compounded Avastin was about 2.5 million units, and biosimilars just over 350,000 units. Clearly, there's a huge opportunity here for a safe, reliable, cost-effective alternative, and BioViz provides exactly that. It's FDA-approved, interchangeable, and manufactured in the U.S., ensuring a reliable supply chain. It also carries the largest phase three data set, giving physicians confidence in both efficacy and safety.
The competitive landscape is relatively limited right now, with only one other FDA-approved biosimilar for Lucentis on the market. That means that BioViz is well positioned to capture a meaningful share from Lucentis, compounded Avastin, and other biosimilars in the years ahead. Now let's turn to Opuviz. As I'm sure you're aware, Opuviz is our Eylea biosimilar, and that also creates a very large market opportunity for us. In 2024, Eylea represented approximately 2.5 million units. Eylea HD brought in about 850,000 units. Vabysmo brought in 1.4 million units, and against that, the biosimilars brought in around 425,000 units. Again, Opuviz is clinically validated, FDA-approved, interchangeable, manufactured in the U.S. Like BioViz, it offers consistency, safety, and predictable pricing. Its differentiated profile and go-to-market strategy position it to capture share not only from Eylea, but Eylea HD and other new biosimilars coming to the market.
This is an enormous market, and Opuviz gives us a seat at the table with a product that is both competitive and durable. Let's take a closer look at what this potential can look like, looking at what Byooviz has been doing in the past year. It's the first biosimilar to hit the market. The first two quarters at launch, Byooviz brought in around $225 million in revenue and is on track to bring in $500 million for the year. This is a powerful proof point that biosimilars can capture meaningful share once they launch. As Eylea's patents expire in 2027, we expect multiple biosimilars to hit the market. The lesson from Byooviz, though, is clear. When physicians trust the product and the supply chain is reliable, uptake can be swift and revenues substantial.
I'm not saying that our biosimilars will follow that same trajectory, but I believe both BioViz and Opuviz are well positioned in the market, supported by Harrow's infrastructure and relationships. It's important to emphasize, too, that Harrow's got a little bit of a different approach when it comes to its competitors. Many biosimilar players view the market like generics, competing almost exclusively on price, which inevitably drives erosion and undermines the long-term value of the product. Our approach is going to be different. We are focusing on patient value, trust, and durability. Both BioViz and Opuviz come with interchangeability status and were developed by Samsung Bioepis, which is important in the biosimilar space. It's a trusted source that they're coming from. Together, Harrow and Samsung bring reputations for quality and stability that matter deeply to physicians. In ophthalmology or with diseases that are sight-threatening, trust is paramount.
Physicians prioritize products that they know deliver reliable outcomes. Our strategy allows us to sustain healthy average selling prices and avoid the race to the bottom, building a durable business in a competitive environment. We don't plan on being here in the short term. We want to be here for the long term, and we're going to be leading the retina franchise in the U.S. Finally, let's talk about TRIESENCE. I know Chad touched on that a little bit. We're going to complement each other very well. TRIESENCE is, again, the only FDA-approved preservative-free corticosteroid on the market with unique reimbursement areas and advantages in both the surgical, which is Chad's team, and then the non-surgical, the in-office setting. In Q2 2025 alone, we're getting some great momentum.
TRIESENCE added 870 new accounts, delivered 32% quarter-over-quarter growth, and the demand in the first two months of Q3 has already exceeded what we brought in in all of Q2. Looking ahead, Chad and his team are expanding into the ocular inflammation market, which is the single largest market for corticosteroids, but our retina team is going to bring in some good numbers, too. We believe strongly that our team with retina will drive significant unit demand in Q4, leveraging the work that we put in place all year long. It's also worth noting that the next generation version of TRIESENCE, which Amir noted, will be ahead of the development of that, will be ahead of its 2029 patent expiration, securing long-term value. With a stable supply chain, strong reimbursement, and a clear pipeline, TRIESENCE is set to remain a cornerstone of the retina franchise.
To close, Harrow is building a comprehensive, durable, and high-value retina franchise. From IHEEZO's innovation to ocular anesthesia to biosimilars that will reshape the anti-VEGF market to TRIESENCE's growth of retina, our portfolio is broad and synergistic, and that makes us very unique in the retina space. Who knows what Mark and Andrew have up their sleeves to add next to our commitment in this market. We are focused on expanding access, supporting physicians, delivering better outcomes for patients, and we're doing so with, like I said before, I think the best team in retina. We have a great infrastructure, and we have trusted partnerships with our physicians. This is how Harrow will not only participate in but lead the next era of retina care. I am extremely pleased to have two renowned physicians with us today, Dr. Sinuhairy Prasad and Dr. Raj Patel.
Both are nationally recognized leaders in the field of retina care. Each brings deep clinical expertise, extensive real-world experience with Harrow's retina portfolio. Their perspectives are really going to be valuable because they not only understand the science and practice of retinal disease, but they also firsthand know our products, how they're impacting patients, practices, and the treatment landscape. We believe their insights will provide important validation for our strategy, highlight the differentiation of our products in the marketplace, and growing adoption we are seeing among leading specialists. Now I get to introduce Dr. Raj Patel. I'm going to try to go through this quickly. There's a lot there. He is an expert in retinal diseases, both wet AMD, DME, DR. He has specialized training in vitreoretinal surgery, and he did his original fellowship. Thank you. He did his undergraduate degree at Northwestern University.
He went to obtain his Master of Science degree in Tulane and stayed in Louisiana to complete his medical degree at the Tulane University School of Medicine. He then continued on with his internship at the Reading Hospital and Medical Center in Pennsylvania, and Dr. Patel then returned to Tulane to finish his ophthalmology residency and then went on to complete his fellowship program in vitreoretinal surgery at the University of Chicago under none other than Dr. Sinuhairy Prasad. Please welcome Dr. Raj Patel.
Thank you for that kind introduction, Allie. As far as where we'll start, I kind of wanted to set the stage of the problem that this product is solving. As we know, the American population is aging. This is due in large part to a lot of different factors, but one of which is the significant advancement of medical care. These gains, however, are a bit of a double-edged sword, in that as people are making it to later ages in life, they're developing a host of retinal conditions that require consistent care in order to maintain vision and therefore maintain a good quality of life. Nothing is more important than quality of life, and I think a lot of the products Harrow brings reinforce that, and I'll come back to that at the end.
The mainstay of these treatments is intravitreal injections to treat macular degeneration, diabetic retinopathy, retinal vein occlusion from hypertension, amongst a host of other diseases. In addition, the advent of new therapies for previously untreatable conditions like geographic atrophy, a subtype of dry macular degeneration, require injections on a monthly or every other month sort of schedule. All this to say that the number of intravitreal injections done in the world is rising and will continue to rise as this trend continues. The question is, with this increasing need of intravitreal injections, there's more conditions that are being treated every year. How can we do this better? I'm not ever one to just stay the same. I always want to bring an advantage to my patients. I want to improve their quality of life, as I said. How do we best perform these treatments? Very carefully is my answer.
In all seriousness, there are a lot of different choices, and each have their advantage and disadvantage. Before getting to IHEEZO, I just wanted to walk you all through what's out there currently because I think it'll help you better understand what IHEEZO brings to the table. The gold standard would be using topical drops. OK, so just proparacaine or tetracaine drops. These are pretty much in every single ophthalmologist's office, in every single exam lane. The reason that was the gold standard is because they're everywhere. It's relatively cheap. They're not a barrier to antisepsis or killing the germs on the surface of the eye because it's just a liquid. The disadvantage here is that while they work quickly, they don't work very well. Injections done using just topical drops hurt, you know, quite frankly.
I mean, it's not something that you're going to sign up to do again, typically. As a result, surgeons started to look for other options. A lot of folks started using cotton pledgets or cotton-tipped swabs, basically a Q-tip soaked in lidocaine, and then it's placed in the injection site. Most of these injections are done in the white part of the eye, the upper outer corner, or the lower outer corner. As you can imagine, putting a piece of cotton there can irritate the lining of the eye, and after the treatment, it can lead to soreness. Also, you have to leave that lidocaine there for a period of time. As you can imagine, an 80-year-old patient sitting in my office chair, left to their own devices with a Q-tip underneath their eyelid, any number of things could happen.
Often, that leads to corneal abrasions, which if any of you have ever had one, you'll know that it is one of the most uncomfortable things that you could ever have because of the density of nerves on the surface of the eye. While you can get pretty good anesthesia by delivering that lidocaine exactly where you need it, unfortunately, there's definitely some downsides. As a result, I'd say more commonly these days, surgeons have moved to using subconjunctival lidocaine, and this provides complete anesthesia. Patients typically don't feel anything at all when you use this. That may have you thinking, great, why didn't everybody just do that? There's definitely some drawbacks. The primary one for me, and again, I'm going back to quality of life, is that when you place subconjunctival lidocaine, almost assuredly, this patient's going to have a hemorrhage in the white part of their eye.
That leaves their eye looking red, not being the greatest with cosmesis. You say that, what does it matter? They have a little red eye. That can last three to seven days, sometimes even longer if it's a big one. When you're talking about these treatments, this is not like a flu shot situation where you get one and you're done for the rest of the year. You're getting a treatment potentially every month, potentially an injection in each eye every month. That's a lot of people at the grocery store asking you, why is your eye red? You know, that gets to be really tiring for these patients to answer. Beyond that, yes, they may not feel the injection after subconjunctival lidocaine. The issue, however, in my experience, is that patients are far more sore after the numbing wears off when using that method.
Last on here, I have high-viscosity gels. What I mean by that are different sort of eye drops. They're thicker. The products out in the market are TetraVisc or lidocaine jellies that are not marketed for the eye. They're great, and they can achieve pretty good anesthesia. However, the high viscosity makes it really hard to get it out of the eye. Additionally, as a result of that, you know that lidocaine just sits on the surface of the eye, and it can actually cause really, really large corneal abrasions. Patients are absolutely miserable when that happens, leading to just days and days of discomfort that could have otherwise been avoided. What is IHEEZO, and where does it fit in? It's special because it's an individually packed, sterile, single-use vial of chloroprocaine in a low-viscosity gel formulation containing hydroxyethylcellulose.
That provides ocular surface lubrication in addition to the anesthesia provided by that chloroprocaine intended for our procedure. When evaluating a new product for me on a day-to-day basis, there's kind of two questions that come first. One is, does it work? Two, is it safe? The answer to the first is here. Basically, what they did was in a small trial, they tested for pain control. The way they did this was they compared placebo, which, as we saw earlier today, can be pretty powerful, to the IHEEZO. What they did is they instilled one drop, one or the other, and then they used forceps to actually pinch the conjunctiva to see how the patient responded, whether they were uncomfortable or not. As you can imagine, your eye is really, really sensitive. You know you're going to know if your eye is not numb.
They found that IHEEZO worked 90% to 95% of the time, depending on the type of instillation. Here we're going to answer the second question on, is it safe? Now with intravitreal injections, the most dreaded complication is an infection. The most important tenet in medicine is do no harm. You don't want to use any sort of product that is going to increase your chances of causing a patient a problem. OK, and so what they did is that basically, whenever we do intravitreal injections, we always have to anesthetize the eye. We always have to clean the eye. Cleaning the eye is very, very important. We needed to know, will the cleaning product, in this case, Betadine, which is typically the gold standard in our industry, penetrate this product and make it to the surface of the eye to kill the germs that we need to kill?
The answer here is that, yes, absolutely, Betadine does penetrate this product because it is a special lower viscosity. It's able to make it through and kill the germs and actually may even have a bactericidal effect of its own, though obviously a larger study would need to be done. I started using IHEEZO about a year ago. I'll say that for me, it's delivered my patients exactly what I need. I find that I get a significant amount of anesthesia quite quickly. I've actually had a decrease in infection rate over the last year that I'm in the process of publishing. My patients have been exceedingly happy with their experience. Many, even a year later, even though they've seen me five or six times since I made the switch, are still thanking me for having switched them to an eye gel that works really, really well.
One of the most significant wins here, though, is not just how well it achieves anesthesia for the procedure itself. I think naturally, you think, oh, perfect, you need to have the most numbing possible. That's all that matters. Actually, it isn't. What really has been the biggest gain for my patients is that due to that low viscosity of the IHEEZO gel, it doesn't stay in the eye forever. It doesn't cause really painful corneal abrasions. It rinses itself out with the tear film, or if you physically rinse them afterwards, quite easily. The hydroxyethyl cellulose works as an ocular surface lubricant, which allows for quicker recovery from the irritation after injections. When you think about the burden of a single injection on a patient, as I mentioned before, it may not seem like much.
You know, you go for a flu shot, it takes a second, and you're out of there. When again, you think about that patient that may need monthly injections, possibly in each eye, you're talking about 24 injections a year. Prior to changing to IHEEZO, often my patients would report they'd need a day or two for their eye to feel the same again and to go back to their normal activity. Now, most of my patients feel back to themselves within hours. That quicker recovery gives that monthly bilateral injection patient back three to six weeks of their life in a given year. I cannot think of something more valuable than that. Many of them, I get emails, texts the same day, my patients that know me, and they're out to dinner with their wives. They're watching sports games at night.
They're having an amazing time in spite of the fact that they have a sight-threatening condition. That's what I mean when I'm talking about quality of life and how much of an advantage it brings. It's all well and good to have really amazing medication. In the real world, you have to be able to get that medication for your patients. I think this is kind of the third question I always ask is, can I get it? Who can get it? Thankfully, it's pretty well covered. Going through this process of getting this medication into my clinics, thanks to the Harrow team, was really, really seamless. We have really good coverage for patients. 90% of covered lives, very few patients require prior authorizations.
The medication has its own established or permanent J code, so it can be used in the office setting, and my billers know what to do with it. It's very easy for them to put that through. You can, in addition to the injection setting, use it in the ambulatory surgery suites for cataract anesthesia. Again, because Harrow makes it their mission to help everyone, I don't have to say, OK, you have good insurance, you get the good numbing. Oh, you're a charity care patient, you don't get the good stuff. I get to use it for everybody without second thought. As a physician, ethically, I could never sign on to using a product where I can't use it for everybody. It just doesn't work for me.
The point is to help everyone, not to treat anybody differently because of where they come from, what their insurance card and their wallet says. Again, quality of life matters. I want everybody to walk out of my clinic receiving the same excellent quality of care. I hope that helps you gain a better understanding of the value that I think IHEEZO brings to my day-to-day clinic. I'll turn it over to somebody very special to me, as Allie touched on, Dr. Sinuhairy Prasad. He's the current Chair of the Department of Ophthalmology at the University of Chicago. Ten years ago, he trained me to do what I do today. I'm very thankful to him for everything he's shown me and really appreciative to have him here joining me this morning.
I'll tell you, it's such a privilege to be here with you all today. You know, in my lifetime, I'll be able to see 185,000 patients in my lifetime. The reason we're in education, I've dedicated my career 20 years at the University of Chicago, and I'm on my 22nd Retina Fellow. Raj was my 11th Retina Fellow. This young army that I'm training, I promised a minimum of 25 fellows in my career. This group of young, very ambitious retina specialists I'm training can see about 3.2 million patients in their lifetime, which means more IHEEZO, TRIESENCE, so on and so forth. It's very special here. I've gotten a lot of thank yous to make the trip from Chicago to come here. I was telling Mark last night that the thank you goes to all of you in the room.
The days of us making products on the bottom of the university basement and coming out with some innovation, those days are over. That's not how innovation happens in our field. It's this triangle between physicians, the investment world, and the pharmaceutical world. This was readily apparent about 15 years ago when the whole design of drugs changed in our field, probably about two decades ago when I first started. The thanks go to all of you for spending the day here. I think this is the quickest, what was it, four hours so far that have gone by. We really appreciate this opportunity to be with you today. Now, just a few words about Harrow and my two decades of practice. I have never met a company, a CEO, that takes the time to come to our meetings and meet with us individually and understand our unmet needs.
At the ASRS meeting, American Society of Retina Specialists meeting in Stockholm, Mark was at the meeting. He met with myself and other respected colleagues to understand our unmet needs, what we need in the field, the importance of a proper supply chain, what was needed for us to take good care of our patients. No other company does that, a CEO of a company walking around the hallways of the meeting, meeting with us. That means a lot to us. Allie also mentioned that the supply chain, the consistency of the supply chain is so important. You take TRIESENCE, for instance, there was a five-year period. We used to use it like water, and there was a disruption of the supply chain. Now Kenalog, there's a disruption in getting Kenalog vials. This is very difficult to manage in our practices.
A company which understands our unmet needs, the changing fiscal environment from federal policies. I'm going to talk about this later in this portion of the lecture series. Understanding what our patients' needs are, these are all very important. This slide is a very important slide showing the prevalence of disease in our practices. It's not showing the number of patients we're seeing, but it's showing the breakdown of the diseases we're seeing in our practice. About a quarter of our patients are macular degeneration, as seen in the first two bars. About one in five patients have retinal vein occlusions and diabetic eye disease. What this does not show is the number of patients we're seeing. When I started in 2005, I saw about 2,400 patients a year. Last year, I saw 6,500 patients. The population is getting older. It's a snowball effect.
Every patient that needs a biosimilar, every patient that needs an injection in the eye, that's a repeated number of visits throughout the year. It's a snowball effect. It's very important to comprehend. I don't think the proportions will change too much, but the numbers of patients we're going to see are going to increase dramatically. Undoubtedly, age-related macular degeneration is the leading cause of vision impairment and blindness in our country and perhaps the world. 196 million patients globally, but by 2040, 288 million patients. There is no doubt that cost is a serious barrier to optimal anti-VEGF treatment, and it is getting worse and worse. Every week, denials and all sorts of issues and tiered policies of what treatments we can use first. It's all about cost cutting, expense cutting. It's very important that we have various options to treat our patients.
This is a very important slide that shows that biologics account for greater than 40% of U.S. prescriptions, as you can see in the left side of the pie charts. On the right side, you see that it only accounts for 2% of prescription drug use. Just to try to understand what this is saying, that this small sliver is such a huge expense for Medicare and the rest of the payers. Once again, this expense to society, the access to our patients, this is very problematic and getting to be worse and worse on a weekly basis with changing federal policy. The biosimilars, why are they important to us? They improve access to care. There are many payers. This is the first line. If patients fail this, then we may try other options.
It increases the number of options we have for our patients, but once again, to lower cost. As of September of this year, 77 biosimilars have been approved. This is something that's really becoming a well-established approach to patients in multiple disease states. BioViz is a biosimilar referencing Lucentis, and it's FDA-approved for the treatment of neovascular wet AMD, macular degeneration of the wet type, and macular edema following retinal vein occlusion and myopic choroidal neovascularization. This is a serious problem overseas, perhaps upwards of 20% of patients with subretinal neovascularization overseas is due to myopic CNV. Very simple registration trial. This is the layout of the study. Patients were randomized one to one, Lucentis versus BioViz, the biosimilar. Lucentis is a reference product. The assessments you would expect in these types of studies are looking at visual acuity and drying central retinal thickness on the OCT.
Focusing on the left side of these slides, blue is BioViz and black is Lucentis. If you look at the time course of vision change over the course of one year, they're essentially superimposable. You cannot tell the difference between the biosimilar and the reference product, Lucentis. Likewise, when looking at anatomical data based on OCT of the macular thickness, the blue and the black lines essentially are indistinguishable. There is no doubt that the phase three data supports the biosimilarity of Lucentis and BioViz. The first biosimilar was approved in 2015. As I indicated earlier, in September of 2025, 77 biosimilars across all different therapeutic areas, oncology, rheumatology, endocrinology, but only recently in ophthalmology. We're just starting in ophthalmology. Look at the cost savings. This will only increase exponentially. The health care system saved $20 billion in 2024. Since 2015, $56 billion.
Just think about the savings to the health care system, which, as you know, is really suffering and trying to cut costs. Biosimilars are very well poised to changes that I predict we will see in the health care system. If you look at this, look at the increase from 2015 to 2024, a huge increase in the uptake of biosimilars. As new therapeutic areas start to adopt biosimilars, this number is only going to increase. Once again, very important that every retina specialist, even a small sliver of their practice, could lead to billions in savings, billions. It's very important. When I talk about federal policy, once again, Harrow of all companies really understands what's going on. We're being squeezed in retina. I know it's hard to believe the way retina specialists do. We do well. The issue is that the margins are squeezed.
Back in 2005, maybe we had $475 per needle we stuck in the eye. Now we're down to $104. The margins are shrinking and shrinking. How does the government see this in terms of the adoption of biosimilars? There's something called the ASP and the Affordable Care Act. We don't want to penalize a physician for choosing a less expensive drug. The ASP can range from 6% to 8% of the drug price. You think of it as a profitability to a retina practice. If you have a $2,000 drug, the profitability is $160 on just the drug alone. If you choose a drug that's half the price, instead of making $80, you still get the $160 of the reference product, as to not penalize the physician for choosing a more sensible, cost-effective option. Retina specialists are starting to understand this.
Payers are demanding that we use biosimilars first line, and it's going to get more and more. This is a very important slide to understand that there is a strong incentive to at least consider biosimilars. Of course, we want to use what's best for the patient. I think that over time, practices are going to understand that there is a very important reason to at least consider the use of biosimilars. Biosimilars, in my opinion, are a smart choice and should be considered. The biologics are very specialized therapies that may be very costly to the health care system. They're cost-effective alternatives, the biosimilars, that can also improve patient access. I practice on the south side of Chicago, and patient access is a serious problem. You have to have biosimilars in your fridge. This is not off-label Avastin. This is FDA-labeled drugs.
There is a very serious and very important difference between the two. The biosimilars are rigorously tested to ensure high similarity with no clinically meaningful difference to the reference product, once again, FDA-labeled. I think retina specialists really should be committed to expanding patient access to these life-changing biologic medicines. The other thing I want to say about projects.
And biosimilars is that there is tremendous excitement about Opuviz. Opuviz is the aflibercept biosimilar, and we expect to get this very soon into our offices. I think that this will really increase uptake in terms of the use of biosimilars in retina practices. I want to switch gears and talk about intraocular steroids. We use all sorts of steroids to treat inflammatory conditions, diabetic eye disease, macular edema following retinal vein occlusion in our practices. They're all different, typically triamcinolone, dexamethasone, fluocinolone, and they all have different durability based on the way they're delivered to the eye. Most of these are intravitreal sub-Tenon's. I want to focus on the top two, TRIESENCE, the Harrow product, and off-label Kenalog. TRIESENCE is not just a branded version of off-label Kenalog.
It is a manufactured and very carefully developed product that I was personally involved in when Alcon got into this back in 2007. Myself and three other retina specialists, we went to Alcon and we really made a case of why we needed an on-label version of this drug. As you all know, that Kenalog, if you look at the bottle label on your Google images, it says not for intraocular use. It clearly says it in big, bold-faced black letters. That really was the straw that broke the camel's back that we needed an on-label version to inject into patients' eyes. TRIESENCE is an on-label version. We saw this issue of inflammation in the eye. It's called pseudo endophthalmitis. Endophthalmitis is a dreaded infection in the eye when you inject anything in the eye, when you stick a needle in the eye. These eyes look quiet.
There's a hypopyon, this layering of a white material in the front of the eye. It's oftentimes very hard to distinguish from infection in the eye. What we later found, it was the preservative in Kenalog that was causing it. That was the second reason that we needed this formulated version that was preservative-free, that did not have the preservative in the vials. The other thing is Raj and my other 22 retina fellows, we trained them to highlight the structures in the back of the eye during vitrectomy surgery. The very fine mill size of TRIESENCE is very important, very different than the crystalline properties of Kenalog. We highlight the structures very well when we use it during vitrectomy surgery. This is the labeling for TRIESENCE.
Once again, it's very similar to the Kenalog labeling, but it is approved for various inflammatory conditions in the eye, but also visualization during vitrectomy surgery. A lot of research has been done, David Dyer's group in Kansas City and others, showing how it can make a huge difference in terms of seeing what we need to see during vitrectomy surgery. Personally, from a training perspective, it really helps my residents and fellows see what they need to see when they learn vitrectomy surgery. It comes, you know, the label gives us a lot of flexibility in terms of how we dilute the drug. In the office, we may use 40 milligrams, we may use 4 milligrams. 40 is sub-Tenon's, 4 milligrams is intravitreal. In the operating room setting during vitrectomy, we have all sorts of dilutions based on the structures we're trying to highlight.
To conclude, TRIESENCE is not just regular Kenalog or regular triamcinolone. I indicated it's preservative-free, and this is a very important property of TRIESENCE to help prevent this pseudo endophthalmitis that was seen with Kenalog and caused a lot of problems. The particle size distribution, the mill size of the product, it's almost like a powder when you use it. It mixes, when you apply it in the back of the eye, it's a very consistent coating of the retinal structures, unlike Kenalog where you have the snowball effect, especially when you inject it in the office. It is FDA approved. Steroids do cause pressure elevation. They cause cataracts. If there's a problem, you better believe Raj and I, we want a labeled product. If that escalates to a problem in the courtroom, I think it looks a lot better than having a drug that says not for intraocular use.
Lastly, the expanded reimbursement access. This is a very important thing to understand, and this is the nuts and bolts of what we do on a day-to-day basis. The payer access is very important to understand, and I'm sure at a later discussion, we can talk about this later. With that, I'm going to conclude, and I look forward to any questions during the question and answer session. I want to introduce John Saharik. He just has been such a great partner in ophthalmology and retina over the decades, and he is the Chief Executive Officer of ImprimisRx. Thank you very much for your attention.
Good afternoon, everyone. Thanks for the presentations today. They've been amazing. I know many of you have followed us for many years, and I have been in healthcare 35 years now, the last 12 with Harrow/ImprimisRx. I had the good fortune of meeting Mark and Andrew in November of 2013. Shortly after that time, the Drug Quality and Security Act was signed, and ImprimisRx became real, right? Back in 2013, we had zero products, zero customers, zero revenue. We started our venture in 2014 with a small pharmacy just over the river in Randolph, New Jersey, and began to serve some states up here in the Northeast. Actually, our two salespeople were based out of the California office, so they had to travel quite a bit to get us started. Fast forward to today, and we generate over $80 million in revenue.
We generate a very healthy EBITDA and a very healthy cash flow. It's been an amazing journey. Today we have 40 products. Back in the day, we had 10 people. Today we have about 170 in the ImprimisRx business. To date, we have served over 65 million eyes. Very proud of that number. All of that product was built in the facilities that are in New Jersey, and mainly, obviously, U.S.-based. Today we have about 15,000 customers that we serve in the U.S., and that is a mix of both ophthalmologists and optometrists. Our product portfolio of 40 products, roughly, has come from that group, right? All of the products that were built and made and developed were from either an optometrist or an ophthalmologist that had an unmet need. It's been a labor of passion. I love the business that we're in.
We have really, it's broken down into three categories. We have a perioperative category, we have a chronic category, and we have an acute category, the smallest of the portfolios, but the acute is actually a very, very important product. It's a fortified antibiotic used for serious eye infections. Doctors call it the Friday afternoon drug because it's hard to find a compound therapeutic on a Friday afternoon. The perioperative is really the biggest part of the portfolio, drugs used prior to surgery. You've seen how many surgeries are performed, ocular surgeries in the U.S. We have the products that are used during surgery, and then, typically post-operatively, you're dealing with a steroid, an antibiotic, and an NSAID. That's really what is the base of our overall portfolio.
Our business, since we started, and again, since I had the opportunity to meet Mark and Andrew, is the land and expand strategy, right? We have a really broad portfolio. We might enter an office with a mydriatic. We might enter an office with a product that's used to dilate the eye. There are just many, many options for us to have that first conversation and that first entry into the practice. From there, we've had a great history of expanding and retaining our customers over the years. We did a five-year projection last year when we were building out our five-year plan for ImprimisRx, and we looked at the customers that were joining us along the way, starting back in 2014. They stay with us. It's a great model that we've built. We solve a lot of unmet needs and help build out that portfolio.
What we built it around: high quality, accessibility, and affordability. That really transfers over to the Harrow portfolio overall. That's what we started with at ImprimisRx. More recently, we had our first example of Project Beagle. Project Beagle was where we had a branded alternative that could better serve that customer. Just recently, since we started it back in February, we took the Clarity C, which was a wonderful, great product that Dr. Lindstrom actually brought to us. It made sense that VEVYE would be a good alternative to the Clarity C portfolio. We executed against Project Beagle. All those Clarity C patients are now happy with their VEVYE drug that's appropriately reimbursed. We also had another product in the portfolio called Clarity. It was a preservative-free tear, and those patients have now been converted to Fresco. That will go on as we migrate over time.
We've got a great opportunity now with the MKL Melt and what's coming with Melt 300. That will be one of the next Project Beagle initiatives. With that, I would like to bring back our CEO and Chairman, Mark L. Baum, for closing comments.
I didn't know I was going to have to come back up here, but nevertheless, let me just thank all of the physicians, the leaders of our business. I have two board members here, Adrian Graves and Perry. There's Perry. I really want to pay special attention to Dr. Dick Lindstrom, who's in the center of the room. When we were getting the business started, I'm new to ophthalmology. I didn't really know anything about ophthalmology when we started this business, but Dr. Lindstrom is a legendary force in not only the U.S. market, but around the world. He kind of took me and this company under his wing and really helped us build this business. This business wouldn't exist without him, frankly. Thank you, Dick. I guess we're going to get to the fun now, the Q&A. Let's jump into that, Mike.
Once again, before we begin that, let me please once again thank you all for being here. It's hard for us to believe, Andrew, that we've been able to build what you've seen over the last dozen years with all of these incredible partners. It's just unbelievable, starting with $1 million. I guess in poker, they say if you have a chip and a chair, you can win the tournament. That's really what we feel like we've done, but we're just getting started. Let's get it going. Thank you.
All right, we have more time for Q&A. If you want to ask a question, just raise your hand and I'll bring you the mic. I'll make it to everyone.
Chase Knickerbocker, Craig Allen. Maybe just Dr. Hari Prasad and Dr. Patel, could you maybe just speak to what percentage of your patients who are getting intravitreal injections get biosimilars today? What makes that decision as far as what biosimilar you use?
We had, once again, you remember from my presentation, we talked about a supply problem with a lot of the drugs we use. Kenalog, TRIESENCE was a big problem for almost five years. And BioViz, actually, we had a disruption for almost two years that we had problems getting the drug in our hands. In the university setting, getting it on formulary and then being able to actually bill for it through our EMR systems, that's a process that takes place. We finally have it back on board and all that. There was a big disruption for about two years. In the heyday, when we partnered with Biogen to use BioViz, it was easily about 5% of the patients that we do injections. It's not insignificant, but the landscape is very different today than about two years ago where payers understand that these are FDA-approved products.
It's very hard for a payer to insist on the use of Avastin, an off-label therapy, to treat our patients. An anti-VEGF that has a label for these various diseases, that's a different story.
Yeah, I would piggyback off that and say it's about 5% of my practice. I think that number has been rising, definitely in large part due to the payers. Also from us, because as surgeons, we don't like, as he's talked about multiple times, we do not like non-FDA labeled medications. The less I use compounded Avastin, the better. We actually have been actively lobbying against the insurance companies to say, you know, when we talk about step therapies, you may know, the insurance companies say, okay, you have to use three Avastin, have a follow-up, then document that they didn't do as well as they needed to, then they graduate you to some other medication, and they're kind of calling all the shots. What we're trying to do in return is say, how can you make us use a non-FDA labeled treatment for this patient at all?
We're trying to get the use of these biosimilars going because that's a perfect first stop for a patient. It's labeled for them, it's economical, it's safe because it's coming from an actual pharmaceutical company instead of some Joe Schmo pharmaceutical, like compounding pharmacy in the middle of Alabama. If you've, you know, followed the news, there's been outbreaks of endophthalmitis because of some of these really shoddy run compounding pharmacies. We don't want to ever see that, you know, and it's a big problem. I think this is a really good solution to that problem.
I'm so glad Raj brought up that topic about, you know, sort of the pathway of how these drugs get into our hands. Avastin is compounded. We take a big vial of Avastin, the oncology vials, and one large vial goes into about 14 to 18 Avastin syringes versus BioViz, one vial, one patient. That's it. If there's a horrible event, some sort of endophthalmitis or some sort of infection in the vial, one patient goes blind versus 18 patients. It's more than just the FDA labeling, the difference between Avastin and biosimilars, but rather there's actually a very practical reason one vial, one patient is strongly preferred.
Mark, maybe can you speak to how you guys expect to do biosimilars a little different? The first launch with BioViz, the first time similarly had a fairly dominant market position. How do you change that this time when you relaunch under your brand?
Yeah, I think, and Allie talked a lot about this, and first of all, Allie mentioned the quality of the team. I don't know that there's a team quite like the one that we have and that we've been able to assemble. We're not going to play just on price. We're going to talk more about this, I think, Andrew, as we get further into next year in terms of how we maintain not only the service levels to the customers, which is part of the plan, but more importantly, that we have a durable presence within the market. We don't see sort of a death spiral on pricing, which is what you've seen with other biosimilars into the market. We're going to talk more about that as we get closer to the launch.
The key for us, and I touched on this, I think several of us touched on this, is we don't get into a market so that we can participate for 12 months, 18 months, or even two years. I've said, for example, we're going to sell more TRIESENCE hopefully in 2035 than we do in 2025. We will participate in the biosimilars market for many, many years to come. We also think that anti-VEGF therapy will dominate the market for a long, long time. I would always refer to the docs on that, but we see those as the strongest products to treat this disease for maybe the next decade or so.
Hey, Thomas Flaten, just to follow up on that question, though, particularly in the BioViz market, what accounts for the penetration of compounded Avastin rather than moving to BioViz? I mean, it was startling how big that column was in Allie’s slides.
Price. It's just price.
It's all about patient access. It's highly problematic. Even with a biosimilar, it's less expensive, but it's not $31. We really need Harrow to partner with our practices to have patient access programs, which I can personally say are very strong and, you know, similar to many of the large pharmaceutical companies like Regeneron, Genentech, and the others. These patient access programs are going to be very important for the biosimilars as well.
From my perspective, this is an ethical thing. My father's here, actually. If my father had this disease, would I want him to get repackaged Avastin? Heck no. I don't want him to bear those risks. He may be able to afford the good stuff, as I said, but everybody, in our view, should be able to get the most efficacious and the safest therapy. That's an FDA-approved product. That's what we think about when we think about access solutions. That's the way we've operated the business, the way we've built the business, and the way we've created relationships with doctors. That's what we'll continue to do.
I've found that if we make a little bit less on the front end over a longer period of time, our relationships are so much stronger and we create so much more equity and value for our stockholders if we just do the right thing. Doing the right thing for these patients is ensuring that they have access to an FDA-approved on-label therapy at an affordable price.
Switching gears a little bit to Larry. It's been a minute since we saw the Melt 300 data, but we're not looking for an NDA submission till the first half of 2027. Can you fill in that timeline? It seems a little bit long.
Sure. I'll let Amir chime in here too. We've got some ancillary studies to run. There are four studies that need to be run. One is a RATTaX and three are PK studies or labeling studies. We're going to get those kicked off here very shortly. We should have that data and the final study reports in 3Q of next year. In parallel, we'll be assimilating the NDA. I think 2026 is still doable. Filing it next year is still very doable. I'll let Amir.
Yes, yes. Hello. Yeah, obviously we're going to try to beat the timeline. Anything we put out, we either beat it or meet it. That said, Larry pretty much walked you through what needs to be done. There are numerous activities that need to be put in place. If we were to tell you December 31, 2026, I don't think it would make a difference. We are confident with the 2027 filing.
Yeah, sorry, I had a water accident here. Mayank Mamtani from B. Riley Securities. Thanks for taking our questions. Maybe a financial question. I saw the 2027 quarterly revenue goal stayed the same. Couldn't help notice the line item under retina or disease portfolio going from, I think, $20-25 million to, I think you're talking about $140 million by the end of 2027. If you could maybe talk about what the different components of that business line item is. It looks from your biosimilar timeline that doesn't come live until the second half of 2027. It looks like a lot of growth in IHEEZO and TRIESENCE. Maybe talk a little bit about that.
Ali, you want to come up here? Mayank, thanks for coming, by the way. Good seeing you. Importantly, on the retina side, we do have two new products coming to market, 2026 and hopefully in 2027, with BioViz and Opuviz, respectively. Those are massive markets, massive opportunities. We're seeing with that first ILIA biosimilar right now, the opportunity within that market. I think it's only going to get better for these biosimilars over the next two years as we prep for that launch. We're going to have time to prep. I always tell people when we do deals, a lot of times we're buying the product, it might be post-approval, and we're kind of building the plane while we're going. VEVYE is a great example where we acquired the product and we launched it like two months later.
We had to kind of figure out the launch plan along the way. Opuviz, we're going right into an existing market that is massive, $8 billion, $9 billion. We've got time to kind of plan it out. We've got the relationships already in place with IHEEZO. We even get kind of like a test case with BioViz, which is a great product as well. Everything's going to lead up for that product to be really, really successful. I think it's going to have an immediate impact. BioViz is also going to have a really big impact. I think it's going to be a pretty quick uptick as well. I'm putting a lot of pressure on Ali right now, but she can take it, trust me. IHEEZO is rolling. It's going to be a rising tide for that product as well. It's already picking, getting more uptake within retina.
Ali and her team are doing a great job building awareness for the product. You'll see that product come up as well from a volume perspective. I'd love to put out a bigger number, but Ali's already got enough weight on her back. I definitely think she can do even better than what we have.
On the HAFA (Harrow Access for All), it seems like an extension from VAFA (Vivye Access for All). It looks like the big focus is on the surgical specialty products. You also had an IHEEZO Access for All launch recently. Maybe just talk a little bit about your learnings from both VAFA (Vivye Access for All) and IHEEZO Access for All and how you think about that evolution going from a patient who's on a $59 script to maybe getting them on a commercial insurance script. Thanks for taking it.
I think the whole, all these access for all programs are centered around what I tried to talk about. That is, you know, over the last dozen years, I love going into physicians' offices. I sometimes will get there before the salespeople get there because I want to talk to the staff or even sometimes talk to patients. When you meet the people that these doctors are treating, you really need to, if you're smart, I think as an executive, help the doctor take care of all of their patients, the rich, the poor, the ones with good insurance, bad insurance, or no insurance. Make sure they get access to these medications. We have such a broad portfolio at this point. Frankly, I think it's incumbent upon us to make sure that these products are available. Natisen, for example, is the only FDA-approved antifungal.
The drug that John and his team make for these sight-threatening infections is refrigeration stable, and it's in physicians' offices to make sure that these patients can get taken care of. What we're trying to do, big picture, Mayank, is partner with the doctors and really build, and I hate the word ecosystem, but really a platform that they know they can reliably access, that we partner with them to make sure that if their patient has a need, they will get affordable access to that medication.
What you will see with HAFA, the broad program that I've worked with, with Prashant, who's my partner here, on a lot of this stuff, is a series of decision trees so that a physician, if it's a cataract surgeon, can come up with a protocol for that patient, or a LASIK protocol, or a retina protocol, or a you name it protocol, and that we can take them through a series of medication choices for those patients that they approve in a seamless, efficient way and ensure that the patient gets access to the most appropriate medicine, consistent with what the doctor's office wants. It's a series of digital decision trees that will be made available in the second or the second phase of the program. Does that make sense? Thank you, Mayank.
Steve Sitos with Canter, and thanks for hosting the event. It's great to be here. It's a great event. Wanted to ask, maybe first on Melt, just with respect to the label expansion strategy and any clinical studies that would be required, timing of those, the scope of those, and just what to look forward to, even between now and approval and subsequent to approval.
Yeah, I have a perspective also. I'm going to show it at the end.
In respect to the label expansion, we'll have to go back to meet with the FDA. I would think of the pain, you know, the Lortabs kind of the world. When they go to get their label, you know, they don't run studies in every single, you know, pain state that you can be in. They find three representative studies: third molar extraction, abdominoplasty, and bunionectomy. We'll have to get agreement with the FDA in some sort of analogous way. Sedation. We've already done cataracts, so we'll go back to the FDA, talk to them, you know, what other representative procedures would they kind of make them satisfied with giving us a broad sedation label. The product will get filed, let's just call it early, let's call it early 2027.
As soon as it gets filed, I believe we should meet with the FDA, get that nailed down and begin the work, and then do that work while Melt 300 is existing on pass-through for cataracts. That's plenty of time.
I mean, the short answer is it's up to the FDA.
Yeah. The second short answer is there will be other studies. Yeah, there'll be more.
The good news here too is because, and I mentioned this in my talk, what we did is we met the combination rule for every combination product. You've got to meet the combination rule. Future studies now are just going to be against placebo. There won't be an active comparator. That's a big deal.
You can do placebo-controlled studies for the indications that, yeah, okay.
Right. There's rescue involved, right? They're not, patients aren't going to be at risk or anything, but the next studies will be active Melt 300 versus placebo because we met the combination rule.
Okay.
I was just going to add, one of the other things we didn't mention in the press release or even in the AK is that Melt really is more than Melt 300. There's actually a Melt 210 program that was a part of this Louise study, which is midazolam only. There's a significant body of data against midazolam in the form of the Zydis technology versus placebo. We have powerful data there as well. It may be the case that we have more than one product that we can talk to the FDA about.
The other thing to note is that in anesthesia, it's a little different than ophthalmology. We're happy to use things off-label. Standard of care for our type of field is what a reasonable practitioner would do in your shoes. That's not really a hard bar to meet if you're talking about procedural sedation. Once I envision it hitting the market for cataract surgery and you have it now in our tool belt in the anesthesia realm, you'll start using it for other things, whether or not the label is there yet. Our standard of care is kind of set differently. It's already a safe drug. It's a sedation drug. Anesthesia depends a lot more on the experience of the practitioner using it.
I envision most people, once they kind of see it, use it, they'll start doing exactly like I do every day with the compounded version: whoa, can I use it for this patient? What about this patient, and start kind of pushing the envelope. I get a lot of calls already from office surgeons asking about its safety profile. That's probably my number one common question because it's surgeons having to administer it traditionally in the office. Personally, I think one of the greatest things about it is its safety profile. Right now, when I go into offices and I hear what kind of, I'll use dentistry for an example, and they're giving a narcotic, they're giving a Percocet, they're giving a Phenergan, which is an anti-nausea medicine that also is a potent sedative combined, and then sometimes a Valium with it. I think, oh, the horror.
We're lucky more patients aren't dying in offices because those are really dangerous combinations. We've found and they continue to study that the safety profile is extremely forgiving when you leave out the use of a narcotic.
Can I just follow up on that and what you commented on in your presentation, just the different use cases? It's related also to the fact that I think there was mention in the deck of $500 per unit drug price that would be relevant for the reimbursement. How many units are, like what is the average number of units that you would need for cataract versus the other procedures that you're familiar with with MKO MELT?
It's an excellent question. The compounded version and the Melt 300 are slightly different. Most of us who had used the compound thought we should increase the ketamine component of it. I'm really excited to be able to use Melt 300 in my practice. I think this version, and in the studies they used one, I think we'll be going down to one from the standard two of the compounded version that I'm currently using, which has a lower dose of ketamine. I think we'll have to use less. It's also somewhat, again, anesthesia sedation is a little bit of an art. You also have to get used to using the drug. As people start, they'll either overdose or underdose, and I don't mean overdose as in harm to the patient, give more than they need, or give too little, and you'll find that sweet spot.
I do think that they hit it perfectly with the one being all most patients need.
Great. Maybe just for Mark or Andrew, if you wanted to take the opportunity, you wanted to ask just on VEVYE volume, net price, refill rate, reimbursement in third quarter, quarter to date, if you have any comments on how the quarter has been.
I'm the wrong guy to ask. I'm always telling Mark, we're putting out too much script information because all of our competitors see that data. I can just say what we are seeing with refill rates and the continuation of product demand for the product is very, very strong in Q3.
You know, I wanted to add one thing, go back to the prior question, because I think it's interesting on Melt, and we were excited about Larry on the phase three data. The three milligrams of midazolam on the PK side of things converted to what equivalent in IV? About 1.75 cc.
If you think about 1.75 milligrams, is that enough to...
Yeah, the typical dose of IV midazolam that's used is 2 milligrams. It was extremely close. I think the difference between 1.75 and 2 is an insignificant clinical difference. Also, to comment on the price per unit, a lot of these office-based procedures are out of pocket. These are patients that are paying $30,000 plus for dental restoration, cosmetic procedures, and all of that, and adding $500 for their comfort. I usually find patients not even flinch in the substantive area when you're talking about some of the office-based cash business.
We have to see also how we price it. I mean, there's an ophthalmic opportunity with pass-through, and then there's a much bigger opportunity not only in ophthalmic surgery, but in these other use cases. We have to see ultimately how the product is priced.
Hello, Lachlan, Henry Brown, William Blair. I guess the first question was Dr. Patel, you were talking about IHEEZO, and you want to be able to give everyone the good stuff. Do you give everyone IHEEZO? Are there patients that you don't give it to, and if so, why? Are there clinical situations that you wouldn't do it, or are there still some access barriers?
No, I appreciate the question, actually. I was going to piggyback off of what Mark was kind of saying to the previous question about Harrow Access for All. You know, Allie and her team have made it seamless for me to provide it for everybody. I don't have to give second thought to anybody's insurance, and I don't make it a habit of ever checking. I just look at the retina in front of me and the patient as a whole, and then we make a decision on what their best treatment plan is. Harrow's been excellent at just taking that out of the equation. I always tell people whenever I was training residents, going into retina is a fast-twitch sport because you're seeing 50 to 90 patients in a day, and you're making decisions really, you have to do it at an efficient pace.
When it comes to a numbing agent, you don't want to have to do different things for different people. That's one, it's not fair, but two, it's also unsafe. When you start to do different things across the board, something's going to get missed, something's going to be done wrong. Here, I didn't have to ever do that. I actually, when I talked to my sales rep initially, she said, "Yeah, you can make it your standard of care." I said, "What do you mean? That doesn't compute." As a doctor, that never ends up being the answer. There's always an insurance problem. There's always somebody telling me, "No, I can't use what I want for that patient." No, I use it on every single injection, whether they have platinum-plated insurance or they're seeing me and I'm doing pro bono care.
All I have to do is ask my rep, "Hey, I'm running low on my samples. Can I get more?" I sign a form and they come. They make it really, really seamless to get it going. The biggest thing is just, I think for people that are used to doing things a certain way, it's hard for people to change, right? You get in the habit, 10 years of doing something, 20 years of doing something, any one of these docs up here will tell you, you just, you get into the rhythm of things and it's hard to change. Interestingly enough, I'm the second of three surgeons in our group. There was one that's 10 years senior to me, and then I recruited somebody a couple of years ago. The senior doc, if you remember in my slides, he was using topical drops and had been for decades.
The one that I recruited had been using subconjunctival lidocaine his two years of practice. After three months of me doing what I was doing, they both changed, not from me telling them anything, but purely because the staff who were administering the numbing agents, the staff who were answering the phone calls after patient care was done, were telling them, "Hey, Dr. Patel doesn't have any people calling us back after hours or later on in the afternoon because they're uncomfortable." They both switched, and I didn't say a word to either of them. That does not happen often in medicine.
Yeah, thanks. I guess for the company, I think a few of you mentioned that with VEVYE and VAFA, the addition of the second pharmacy partner should or is increasing coverage rates. Can you maybe just elaborate on that? Give us a sense of how much of an impact you are seeing or expect to see with the addition of Apollo Care on top of FillerX?
Yeah, unfortunately, you sign up with these specialty pharmacies. You don't have complete visibility into their pharmacy network to determine what the overlap is. You can make an educated guess, but we don't completely know the entirety of the overlap. We do have a belief that we've significantly expanded the overall pharmacy network and the contracting that those pharmacies have with the plans. This is a new relationship with Apollo Care, so we need to collect some data. I think, you know, Prashant said it, we're sort of pharmacy agnostic. At the end of the day, if a pharmacy partner will submit to our business rules and our algorithm so that the patient gets treated appropriately and that the physician's office has a high-quality experience, we will bring them on to this program. Candidly, we're open to other competing products even joining our platform in the future.
At the end of the day, the vision for Harrow Access is to really make sure that every physician can take care of their patients in an efficient way. We do have a broad product platform, but if others are interested in being a part of it, we're open to discussing that too.
I could tell you from my clinical experience, you know, I probably write about 50 to 60 prescriptions in a day that are refills or first new prescriptions. It's very rare for the drug not to go through for that amount. I have a good team. They've been doing it a lot. They know how to do PAs. They spend a lot of time, unfortunately, in that area, and perhaps that skews it a little bit. In the rare case that it does happen, that's where I'll use samples if that's the drug that is the most effective for them. Overall, I felt like the success in my clinic with this approach, and a number of companies have been wise enough to use these online pharmacies, is far better than our experience in the past. VEVYE's, you know, a unique $59 seems to be vast. I'm well over 95%.
I feel like I could certainly verify that with my staff.
We are starting to see coverage improvements. What I can tell you is that it is a slow slog, right, Maria? It is tough. You have to be very patient, but we are starting to see coverage come in at rates that are attractive for our stockholders. It's unwise for us as executives to submit to the rates that a lot of these other companies have submitted to. They're literally losing money on every prescription, and that's not really sustainable. By the way, thank you for coming, Lachlan.
I appreciate it.
Of course. If I can ask one more, when you introduced VAFA, we had the price reset, you know, obviously with a big growth in volume. How should we think about that kind of dynamic with the VAFA across the broader portfolio? Should we expect some kind of reset at some point in the next few quarters as you maybe see a decline in price or an increase in volume?
I think everything that we've done so far with the program with HAFA is theoretical. We've done a lot of modeling, and we have a lot of internal data that suggests that this should dramatically increase volumes and ultimately profits that we generate from this program and open up access, which is sort of the three key factors. It's just theoretical. We need to, as we did with VAFA, put it into practice. We're going to do that beginning here in the next couple of months.
Okay. Thank you. Tom Schrader from BTIG. Thank you for the remarkable event. I want to stay with Dr. Karpecki. When you treat for dry eye, do you overwhelmingly treat with a cyclosporin or any of the alternate drugs squeezing the class? I guess what I'm really asking is, should they add a non-cyclosporin?
That's a good question. Typically, and again, my clinic is 100% referral. The patients have already seen a good doctor. They've already been managed. This is kind of a last stop. I tend to begin a lot with steroids, believe it or not, topically to begin for the first month for a couple of reasons. One, if they respond to that, I will go to an immunomodulator, whether it be, you know, VEVYE, for example, could be even lifitegrast. It depends on what, you know, how they, what they have coverage, what's available. From the cyclosporin class, VEVYE is a very easy choice. Just the tolerability, how quickly it works, it's there.
I'll typically start with a steroid because if they don't respond to the steroid, I'll go down a path of biologics, which would be amniotic membranes, serum tears, something that is very similar to the way immunology manages patients systemically. It seems to work well in the dry eye space also. That's a more typical approach with the patient population I see. With my colleagues who I educate a lot, and that's one of my goals, keep elevating the dry eye across the professions, they won't see that level of patients at the beginning. They are going to begin with something that they have access to, that goes through, that's reasonable for the patient, but that is in that category of immunomodulators and steroids a little less at the beginning of their process.
I do feel like, though, when I talk to even colleagues within my practice, that their goal is to try and get the right drop into the patient. They are moving faster away from an artificial tear. Meaning they may keep the patients on artificial tears, but they understand they're not going to get the results they want without prescribing a prescription medication. That's a big trend that's starting to happen at the primary eye care level. For their decisions, it's what is comfortable. The case I showed you was a, I wouldn't say he's an average primary care physician, but he does a lot of everything, glaucoma and glasses and contacts. I don't do any of that stuff. He says that for him, his first choice is VEVYE. That's based on clinical experience, his results that he's seen, where it's at.
That might be a good proxy for general practice. It comes down to access, what's available, comes down to experience, and it comes down to the response to the first drug. To be fair all around, there are some Xiidra super responders. I can't pick them out right away, but when I put them on it, I can't move them even to something as great as VEVYE. If they lose access, I've got to find other ways to kind of get them there. There are unique approaches depending on the patient presentation. Mucin deficient, which is where I have staining on the way to the eye patients, responds slightly different. They like Flarex far better than loteprednol. Maybe a patient that's in an evaporative state tends to like those lipophilic drugs, like loteprednol or equally. It's getting nuanced to that level.
In general, I think doctors like to use something that they know is safe, comfortable, quick, and tolerable. That's why I think VEVYE will probably be used there. In my clinic, it'll have to show success with steroids, and then I'll move to a drug like that.
Okay. And if I can follow up with a very general one for Mark and Andrew, I thought it's telling after the deal, you only kept $10 million of dry powder. Do you think you're largely done adding products? Would you be highly opportunistic from now on? Are there obvious holes where you think you're really looking? A related question is, how fertile is the Project Beagle pipeline? Are there obvious huge compounded drugs that are just ripe to be spun out? Are the good ones out? Thanks.
I think we've, you know, when we look at the field, there are probably fewer targets today than there were five years ago, for sure, because we've acquired most of them. There are really interesting products out there. We always say if we can buy a dollar for a dime or even a few pennies, we'll do it.
Our stockholders should expect that. There are a few things that we're looking at. There was one that we were far down the road with recently that we withdrew from. It's got to fit into one of those buckets, the surgical bucket. It's got to make Chad's team more powerful. It's got to make Allie's team more potent, more important to the customers that they serve. Same thing with Maria. There are a few things that we're involved in. As you've seen, we like structured deals. We don't like to pay full price. Some people call us cheapskates. I don't think our stockholders do. I always say there's like a greed desperation continuum. They have to be sufficiently less greedy for us to be able to work out a deal with a potential seller.
Very few are at that stage, but there are a few that we're looking at that we're really interested in. I think we're really excited about some of the stuff we've got coming up, but we're not going to blow it. We don't need to blow the bank to do it. We've shown that we can take small amounts of capital and create significant pools of long-term value.
Yeah, Thomas, when we did the debt deal too, one of the things we did that was unique is this was an unsecured notes offering. We went through a rating process that BTIJ did a great job leading us through. It gives us sort of a new platform to raise capital quickly on the debt side too, at a really, really, I think, efficient process, but cost-efficient as well. That was one of the big reasons we went with the approach we did instead of going the private round. It also allows us to not carry as much debt as maybe we otherwise would have had to on the balance sheet. We've got, because we have quick access now, especially as the deal presents itself. We'd like to, I mean, Mark and I have that gross leverage ratio target we talked about.
When we do deals, if we're going to put up money and it's a commercial stage product, our expectation is it's going to be delivering as well. We try to structure in that way with the upfront. Like the Melt Pharmaceuticals deal, for example, the way that deal is structured, we have a payment at FDA approval. When that thing launches, we're going to roll right into those customers that are using the MKO Melt. The expectation is we'll make that payment up quickly. We certainly will have the cash and availability of liquidity with the ABL to make that payment, plenty of it. Importantly, even if we draw down on the ABL, $50 million, immediately it should be a delivering event for the business.
I think along the way, these ancillary studies that we're going to finance are under $10 million, probably closer to $6 million or so. For $4.3 million, which is what we put out, an additional investment of a handful or so million dollars, we should be able to get an NDA filed and get to the point where we have an FDA-approved product as a substitute for a product that we already sell a lot of units. That's how we use modest amounts of capital. I think that'll continue to be our approach to inorganic growth.
Hi, Dave Schiller from Marquandom Capital. The question is, the Access for All program, just wanted to maybe talk about how that affects pricing and margins over time.
When you offer a cash-paid price, let's take a step back to before Access for All. Patients, I had a friend of mine that went to his pharmacy in Denver, Colorado. He was quoted $800 out-of-pocket costs for VEVYE because the prescription was sent to King Sooper's pharmacy in Denver. Whereas if that prescription would have been sent to, you know, FillerX, it would have been accessible at a much lower price. The question is, is that patient, now my friend happens to be a rich guy, is that guy who's maybe not as rich going to be able to pay $800 for that prescription month after month after month? The answer is no. What we had to do is design a program, as I said, that worked for all patients, the rich, the poor, the good, the insurance, bad insurance, no insurance. That's what this does.
Out of the gate, you do take a margin hit. We saw a larger number of patients go with a $59 prescription. Those patients would have been like my friend that wouldn't have ever gotten it in the, they wouldn't have continued with it to begin with. We would have lost them. The question is, how do you, over a long period of time, without submitting to these crazy multi-year PBM contracts, profitably address this patient population? We think that this Access for All program does that. For us, it's all about MIPS. We have some patients that we get commercial coverage on out of the gate or soon thereafter. We do very well on them. Maria, I mean, these patients we make, you know, you can get $600, $700 reimbursements, Medicare, Medicaid. We throw those into the mix and then you throw the $59.
When you swirl it around, you do end up with a very attractive ASP student, if you will. Over time, as we get more coverage, we expect that number to rise as opposed to decrease. Right now, and I'd say since, you know, when we modeled out our original net profit per prescription, we're significantly ahead of where we thought when we were launching.
Yeah, and I can, one of the, Mark and I kind of cut our teeth along with John in the ImprimisRx business, which is cash pay, it's direct distribution. This is really modeled off of that. We're eliminating middle people that we're pulling out of that value chain and driving down our profitability on a prescription basis anyways. That's really the key tenet of the program. Number one, you increase patient access, but by pulling out all these other middle people and having a great partner with FillerX in particular, we were able to become more profitable on an everyday prescription. That's something that wasn't the case in the traditional chain. When we look at the expansion of Harrow Access for All, there's going to be products that we make less money on, for sure.
There's going to be some, this is going to sound crazy, there's going to be some we probably do better on. One of the reasons for that is because Medicare, Medicare Part D typically doesn't pay well for ophthalmology products. There's incredible pricing pressure from the payer. You throw in the middle people's pulling off of that. Our profitability on some of these products is really, really low. By going direct, in some instances, we're actually going to be doing better on some of these products.
I'll add one more thing to that. Dr. Patel mentioned this as well. Doctors also have to pick and choose sometimes who they're going to prescribe for, even in this dry eye category. I know Paul would agree with me on that. We're capturing a lot of those paid prescriptions, not only in our pharmacy hubs, but also in the retail space for that reason. Doctors don't have to pick and choose which prescription they're sending to the pharmacy because they know one way or the other, the patient has access to the drug. They're thinking, dry eye is present, dry eye is diagnosed, I'm sending it and it's going to be VEVYE. We're getting the benefit that a lot of those prescriptions, again, in the retail space are also being covered now.
I think you made a great point of that earlier, not having to pick and choose and have that added hurdle for both physicians and patients as well.
Yeah, there's significant pain as a prescriber when it comes to having to go through this process, right? If there isn't an access program, you are so much more less likely to even think about that drug, even when the really well-insured patient comes in the door. It's just not going to happen because it's just not even on your radar because you can't get it for Tom, Dick, and Harry that came in before them with the really bad insurance, right? In my use case, for example, in a given month, I might use 400 or 500 billed IHEEZO injections. I may also use like 100 samples for these patients that have really, really bad insurance or no insurance or what have you. If I didn't have this program, all of those patients would never have been billed. I would never have used IHEEZO in the first place. Does that make sense?
Just so you get a little insight into kind of how we feel from our end.
Just one thing to add to that. I think when you look at, when we talked about our commercial model, you know, think about all these launches that go out. It's really hard to launch products, right? I think when you think about it often, when somebody says, "I'd like to try it on my patient, but," right? I go back to the example you mentioned in your practice. It's super important that when a doctor writes it, that they know the patient can get it confidently. What happens is when you tell your peers, you know, that replicatable experience really takes off for us as an organization and the product performs really well when a peer tells another peer. That's one of the things that's really important as we go forward in the early stage of our launch.
One, we remove that barrier that when a doctor makes a choice, they can get it. There's a positive experience. Ultimately, we have peer recognition telling other people about the products and recommending them. That's really core with where we're at in our early launch phase and core to our HAFA expansion. VEVYE growing our depth and breadth is really leveraging it where we remove that barrier. It's super important for us in the early stage of launch.
Just know you can't recover from signing a bad PBM contract. That's the bottom line. We are not going to sign boneheaded PBM contracts. They're long-term bad deals. We're just not in the business of losing money for our stockholders. We're demonstrating that you cannot sign these stupid contracts and do pretty well.
All right, maybe one more question, and that's all the time.
Thanks, Ari and Kyle. Thanks again for doing this day, Mark and company. Four quick questions about BICLOVI. Number one, for surgeons, what are the two highest volumes of pain relief medications that are being prescribed today, and what are their names? That's question number two. Number three, number two is what are the volumes for those medications? When we compare efficacy for those two preferred treatments by surgeons, can you just compare those with their efficacy versus what you discussed with BICLOVI?
I was going to say three doors to your left is probably the guy who's used more topical steroids than anybody in the galaxy. If you want to pass the mic, Dick, do you mind talking about topical steroids?
Yeah. I'm sorry, I got the call. You're welcome. Okay, I can repeat the question. Good luck.
I'll repeat it.
Regarding BICLOVI, question number one is what are the two most frequently prescribed pain relief medications after surgery that are used today?
Steroids after cataract surgery, and steroids, which is most commonly used.
What is, you know, what is maybe the annual volumes for those two? The third is when you compare those two named medications, how do they perform compared to BICLOVI?
By the way, Dick is the one who told me about clobetasol several years ago and how physicians wanted access to it.
Routinely after ocular surgery, we don't prescribe any pain medicine other than to tell the patients they can take Tylenol or Advil or aspirin. They do have pain. If you do a study and you evaluate the patient's pain on the first day or two after any procedure, it's meaningful. They have pain, but typically we don't prescribe anything. About 3% to 4% of patients do get an opioid, and certainly there's strong incentives not to use opioids anymore. Typically, it's a codeine-type containing opioid that they obtain. Usually we don't take care of their pain. We'd love to do things that make them not have pain because comfortable patients refer other patients, and patient word of mouth is still the way most of us grow our practices.
If we have something that's safe and effective that we can add to a regimen to make patients more comfortable, that's basically going to be a patient builder. Most of the time we're not doing anything to be direct.
When BYQLOVI is available, your guess is, when BYQLOVI is available out of every 10 patients, obviously some complain about pain, what portion might you prescribe that BYQLOVI, given its benefits and its lack of risk? I mean, would it be 2 out of 10 patients or some other number?
I'm not certain to be direct. I don't really, I can't really give you a good solid number there that would be useful for you, I don't think.
Okay.
Yeah.
All right. Thank you.
To add to Dick's point on Dr. Lindstrom's point on that, every patient will get a steroid. Every patient gets NSAIDs, typically very commonly topical, which we're talking about also here. The range is across the board. There are those who will use even a non-branded prednisolone drop and NSAIDs at times. They'll do compounding through ImprimisRx where they get all three in one. There's some that try to go more branded, which I'd say the bromfenac molecule gets used a lot in that category as an NSAID. Topically, maybe a branded prednisolone, rarely Durezol anymore, just because cataract surgeons are so good at what they do. Not a lot of information, but I think that's where that drug will play. Dr. Lindstrom's right.
We're not going to do a lot for the pain specifically, but it could become the alternative if it's shown to be as good and help with pain and help with discomfort, which would have to be studied, of course, to those typical drugs that are out there and even to compounded options, which are three in one.
By the way, we sell a drug through ImprimisRx for about one out of five cataract surgeries. Every one of those cataract surgeries gets a topical steroid, typically. What Chad and his team are going to do, I think, is offer both, I think, a best-in-class topical steroid for a hundred, I don't know of many cataract surgery patients that don't receive a topical steroid or a steroid of some kind. He's going to have, I think, the best-in-class topical steroid, and then I'll have a best-in-class injectable steroid, all branded.
I just want to add that the value proposition for BICLOVI is really its anti-inflammatory properties as a steroid, less so as an analgesic. It does have data for both on label. That said, really the go-to for BICLOVI, the reason to go to it is really flares and inflammation.
All right. That's all the time we have for today. Thank you all for coming to our first ever Investor Day, and thank you to all our guest speakers for making the trip.
You know what I love? I want to change my mind because this just don't feel right to me. I want to raise your spirits. I want to see you smile, but no, that means I'll have to leave. Know
That means I have to leave. Lately, I've been thinking. I want you to be happier. I want you to be happier. I'll go. Go, go, go.
Hi there, everyone. Just want to make a quick announcement that for all of our Harrow employees and Board of Directors, we'll be heading down for the closing bell ceremony at 3:00 P.M. For all of our Harrow employees and Board of Directors, please stick around for the closing bell ceremony. We'll be heading down at 3:00. For everyone else, please enjoy some refreshments or coffee before you head out.