How's it going, everyone? I'm going to step in. My name is Macaulay Cobain . I work under Margaret Kazer covering med tech. We're going to have Glaukos present for us. We have management with us today. You can go to williamblair.com for a full list of our disclosures. We will have Alex kick it off here.
All right. Thank you all for coming and joining us this afternoon to talk a little bit about Glaukos. My pleasure to speak to you all today. My name is Alex Thurman. I'm the CFO of the company. I get the privilege to talk to you a little bit about what we're doing. Skip over the disclaimer, jump right into it. Our company mantra and culture, we like to say, is we'll go first. Why is that? It goes back to the beginnings of the company back 25 years ago when we had one of our early founders who was a venture capitalist who had a son who had glaucoma. Back 25 years ago, he was considering what are the treatment alternatives for this son who had advanced glaucoma.
It was really boiling down to a procedure called trabeculectomy, which was to put a hole in this person's eye. The VC said to the doctor, there must be a better way. From that statement, Glaukos was originated and was born, where the doctor's response is, I think I have a better way, but no one will listen to me. This VC said, I am going to listen to you. What is your idea? Over time, that became the first iStent. Later on, the development of the MIGS category and how Glaukos was born and started its existence. From there, from that birthplace, innovation has been at the core of all that we do. We are very focused on doing dropless therapies and to do so with commercial excellence that we have developed over time.
Today, we have five novel platforms, we like to say, that cover the products that we are out there and working on or commercialize. We have our iStent franchise, which obviously most of you know about. EyeDos, maybe you have heard about, not sure, just kidding. That is our latest product line. Following that are some that are in the pipeline, which is iLink, which we will talk about, iLution and Retina. On the right side is the therapeutic areas that we try to cover with those products. We have glaucoma, obviously, that we have talked about already. We have what we are calling rare disease, which is keratoconus currently, and we will talk a little bit about that. We have diseases in the anterior segment and then the posterior segment of the eye.
As we look at our five platforms on the right in this wheel, we try to show here are the therapeutic areas that they cover from anywhere from ocular hypertension to keratoconus to dry eye to glaucoma, et cetera. How have we gotten there is through an investment over the last, I guess, seven years of spending more than $700 million in R&D to develop these products and to get them to a point where they're either commercialized or they're coming towards FDA approval. We have 14 programs in our pipeline that we've publicly disclosed. There are others that we haven't talked about yet. That's from where we started when we did the IPO in 2015 of just five programs. We continue to invest and reinvest in the business at an industry-leading level to develop what we think will be a long-lasting journey along ophthalmology.
As we talk about 2025 and this year and next year, what are our key commercial catalysts? First and foremost, it's this concept of interventional glaucoma. Let me explain what that means. One of the reasons that we are interested in dropless therapies, and we'll talk about this in a minute, is that we found that drops, while the active pharmaceutical ingredient in them works, people just do not like to take them. I do not know how many of you out there have drops. It does not have to be glaucoma drops, but drops are just, they can be hard to take. They can cause side effects and things of that nature. Oh, he has got one right there. You brought him with you. A lot of people forget to take them when they travel. There are all sorts of reasons why drops just do not work for these patients.
That leads us to try and go down a pathway with our patients and our customers to say, you need to intervene sooner in patients' journeys because with their drops, the glaucoma just does not seem to get arrested soon enough. Can you intervene earlier with tools that will help to preserve these patients' visions? That is the idea of interventional glaucoma. What are those tools that you can intervene with? Up until just a few years ago, there were not a lot of tools that our customers could use. Now, as we will talk about in the presentation, there are quite a few tools that doctors can use on their patients to help them in this journey. The next catalyst we talk about is keratoconus. We will get into this a little further on, but basically, it is a corneal disease that we are tackling.
We have a product that has been submitted for NDA approval with a PDUFA date later this year. That will be our second catalyst over the next near term. As we move into the next slide, here are some crazy statistics. I see that the formatting is kind of odd. What it is trying to say is that, speaking of drops and what we were just talking about, it is amazing to know that 90% of patients do not refill their prescription. They start on these drops. They have these side effects, whether it is stinging, whether it is red eyes, whether it is dry eye, whatever the case may be. They just are not compliant with their drops. Then 50% of those, sorry, that is 50% is the next stat over, they really just never even refill. They take their drops or they do not take them.
When it comes time to refill those prescriptions, they just forget it. The reasons are, look, the side effects that I just talked about, as well as the fact that with glaucoma, it is a disease that is very slow progressing and one that you do not feel. You wake up in the morning, it is not like your eyes hurt because you have glaucoma. It does not cause a reminder to take your drops. It is slow progressing. You do not see it very often. We, from the very early beginnings of our company, knew there was a need to change this whole dynamic and this whole paradigm.
That is on the bottom half of the slide, where in the old days, you would go in, if you may have noticed some vision coming in on you, you went to your optometrist likely, who then maybe checked you and noticed, oh, you might have glaucoma. We'll send you to a glaucoma guy. That glaucoma specialist might just prescribe you a drop. You come back six months later and you have not really improved. You may have progressed. They do a second set of drops and maybe a third. Ultimately, it led to these very invasive end-of-stage eye surgeries, where they would literally put a hole in your eye to drain the fluid that was building up on the front of your eye.
Today, we want to get into this bottom half, where you've got this interventional glaucoma paradigm or interventional procedures, where you may start with maybe instead of a drop, you start with a laser, an SLT. After that wanes, you go to a pharmaceutical procedure and then maybe a MIGS procedure and then maybe a MIBS, et cetera. Over the time of your journey with glaucoma, which has no cure today, there are several tools in the toolkit to allow you to intervene without having to use drops, which we know from the previous slide do not get used, and slow or halt the progression of your disease and give you as much time in your life with the vision as possible.
From our standpoint, from Glaukos in this interventional glaucoma journey, we think we have now the set of tools in order to help our customers to progress along that path. The first and foremost, which is very common today, is EyeDos. We have talked a lot about it. We hear about it a lot from investors, which is this tool that allows 24/7 compliance. As I mentioned earlier, the active pharmaceutical ingredient in drops really works if you take them.
Our idea here was to take that API and to formulate it in such a way that it could be put into a very small canister, which you can see on the screen there, and implant that canister inside the eye and allow that API to elute over time and treat your symptoms without having to use the drops that have to get through and penetrate the cornea and get in there. You can eliminate all the side effects. Luckily, we have been able to do that. It was a long journey, a 15-year journey, and one that we are very proud of. There are some key things about there. You can see the size of it on the top left, 5 mm is width. That is about the width of five human hairs. That is how small it is.
You can see that the formulation of that API into that ball of oil that is in the middle there, that was a big engineering effort to be able to put that much active pharmaceutical ingredient in that small canister and have it elute through that membrane. One of the really key things that we did early on was to design this so that it would be anchored and stable inside the eye and not float around and bounce around. The EyeDos is anchored, allows that drug to elute into that eye and treat those diseases and those symptoms.
Furthermore, in this IG journey that we call it, in addition to EyeDos, which you can see will treat all symptoms along the spectrum from ocular hypertension all the way through refractive, we also have iStent Infinite, which is a three-stent product that currently is labeled for this advanced and refractory glaucoma. Then kind of our original iStent inject W, and is used pretty much in combination with cataract surgeries to treat glaucoma. You have a lot of different tools to take you along the journey. There are a lot of milestones that needed to happen as we progress on this journey. Most of these are around market access items. We talk about getting through Max and getting coverage through Max, not only with the drug with EyeDos, but also the facility payments and the professional fees. Along the way, several things that have to happen.
You can see a lot of the check marks in 2024 and then a lot of the things that we continue to do in 2025, including things like phase four studies and other clinical data to help support our customers as they go along this journey and start using these tools in a more fulsome fashion. The next thing we'll talk about is what we're calling interventional glaucoma and the forever patient. What a lot of people don't realize is that a typical average glaucoma patient has the disease for 21 years. So 21 years of their life, they're dealing with this disease. And traditionally, let's say, if I was a comprehensive ophthalmologist, I was really focused on cataract surgery.
I would be focused on all my marketing dollars and acquisition dollars to get a cataract patient in and to do one surgery and one shot to get as much dollars out of that patient I could by trying to pitch them basically an IOL that was a higher, what's the word, a premium IOL, sorry, so that I could then maximize my return. With a glaucoma patient, you have the opportunity to have them for those 21 years and do several iterations of procedures on them over the course of their lifetime. They can do, and we talked about it earlier with the IG modeling, where they can start out with a laser. They can get into the several products that we have along the way between EyeDos, iStent, iStent inject, et cetera.
By the way, you'll get the cataract surgery along the way if they have one as well. This forever patient model helps our customers understand that it's a long journey and there's a lot of opportunity for them both to treat these patients effectively as well as do the right thing for their business economically as well. Going back to EyeDos and our phase three data, just again, sorry for the formatting issues, but the main thing here that happened was for 70% of our patients in both the phase two and the phase three trials, these patients were well controlled with their pressures over a three-year period or 36 months, which is just a phenomenal result. I think when we started the EyeDos journey, our CEO said if he's able to get a product that would last between six and nine months, he'd have a winner.
We were fortunate to see these pressures being really controlled for three years. In many cases, the patients were medication or drop-free during that time or at the end of that time. From a safety profile, EyeDos stacks up very well. You can see there in both the phase three and the phase two trials, really no adverse events of any kind and very strong safety profile. We believe that's with the design of the product and how it's working and seeing that. One of the key things we talk about today is now that EyeDos has been approved and commercialized, the clinical results we're hearing from our customers in the real world are even as good or better. There is a lot of clinical excitement for the product as it's gone out into what we call the real world now.
Talk a minute about combined therapy, which is the combination of two different things. On that pie chart on the top left, over half of patients today use what they'll call combined therapy, meaning more than two drops, two or more drops today. Surgeons and doctors understand the power that can be done with multiple APIs or multiple procedures in the same patient. We have looked at it in combination of having cataract and EyeDos together. There were some profound reductions in the pressures of those patients that had cataract surgery along with an EyeDos. You can see that on the bottom part of the graph, where 44% reduction in pressure from the baseline. That represents about an 11.3 drop in millimeters of mercury.
From a market opportunity perspective, we like to show this because on the far left of those funnels is the cataract market. That is the historical market Glaukos played in when we had to do our stents in combination with cataracts. You can see it's only about a 500,000 market. When we look at the total amount of patients in the United States that either have ocular hypertension or some form of glaucoma, it's 22 million eyes, of which 13 million have been diagnosed, of which 12 million are being actively treated in some fashion today. That's a huge step up in the opportunity for Glaukos and others to get into what we call the standalone market and taking it away from just having to do things in combination with cataract surgery. Here's the IG roadmap that Glaukos has and all of the different things.
You can see in green the stent products that we have either already approved or in clinical trials. The blue talks about our EyeDos. Again, EyeDos, we've only got generation one out there right now currently approved. Some of you know about our next generation, which is called the T-Rex or TR Extended, which we hope that in theory would be twice the amount of pharmaceutical ingredients. Hopefully, or we'll see, twice the duration. That is in a phase two, phase three trial. Beyond that, we have other generations of EyeDos. We have iLution, which we'll talk about in a minute, which is a cream-based drug delivery system, and then some other tools at the bottom. All of these tools are available for our customers to treat their glaucoma patients along the spectrum.
As we build this business, we've always said that the journey for interventional glaucoma is not a six-month journey. It's not a two-year journey. It's more like a 10-year journey. There are various phases that we like to think about. The first phase was just getting these surgeons to buy into the idea that they need to intervene earlier and get away from this knee-jerk reaction or historical reaction to just prescribe a drop and then more drops and drops.
What is very encouraging to us is that in the recent ASCRS conference, the very first day was a three-quarter day symposium that was put on by the society called the Business of Interventional Glaucoma Surgery, where they met with not only the surgeons, but also practice administrators, back office staff, revenue cycle managers, et cetera, to talk about what IG means, what that could mean to their practice, and how do they operationalize it. Very encouraging as we get along. What we're seeing in this step one is we continue to push that messaging. Step two, we've already talked about is this idea of combination therapy. For example, in EyeDos, the design of that API is to slow down the production of fluid in the eye as opposed to the stent, which is designed to drain the fluid naturally in the back of the eye.
Together, those two are complementary. Can they be done in combination? Should they be done in combination? Every surgeon will have his or her own algorithm, but we believe that that combination therapy can be very effective and very powerful. We are going to continue to support our customers through data and other things to help them to understand that and push that. Three is that we have many customers that would like to do, for example, procedures in the office. Today, EyeDos is done primarily in the surgery center. Can it be done in the office? It can. How do we support that? We have a next generation EyeDos where we will design an applicator or an inserter that allows EyeDos to be done in the office setting.
We want to be to a place where we are agnostic as to whether our customers choose to do a procedure in their surgery center or in their office setting. We will move towards that over time. The next step is to, again, as I mentioned earlier, the T-Rex product where you can get an EyeDos that is basically hopefully twice as long, lasts twice as long as our original EyeDos. Continuing to offer longer solutions to patients, less invasive for them, and hopefully just as good at outcomes as we see today. Beyond that, we talk about the fact that PE groups today are really consolidating the ophthalmology practices around the country. They really understand the financial side of this idea of interventional glaucoma and the forever patients as well. We continue to build upon that as those PE groups continue that trend.
Last but not least is really this long-term vision where you see our ophthalmology comprehensive surgeons as well as glaucoma specialists who understand what the glaucoma patient and the disease means, the opportunity to all, and the idea that they can have a practice that is very robust and treating glaucoma just as much or more than today with their cataract practices. Based on that funnel we talked about earlier, there are two and a half times as many eyes with glaucoma as there are cataracts today. There is a huge opportunity for them if they can see that vision. We'll help them to do that. Okay, switching gears a little bit to corneal health. There is this disease called keratoconus, which is basically when you have a cornea that has weakness in the cornea and the cornea bulges out. You can see that on the bottom left.
There is really no other FDA-approved procedure other than our iLink, where Fitrexa, the name of the product, goes in and arrests that development, restrengthens the corneal fibers through something called cross-linking. The challenge with Fitrexa today is that you have to, for lack of a better word, scrape off the outer layer of your cornea in order to put this drug on it. It is very effective, but it is also very invasive. Our next generation product is called Epioxa. Epioxa allows you to treat that patient without touching the cornea, so to speak, not having to scrape off that outer part of the cornea to apply the drug. This will allow, obviously, a much less painful procedure and a quicker recovery time for all of these patients, most of which are in their teenage years.
It is difficult for them to spend time recovering when they are in school and other things like that. We have submitted our NDA, which was accepted last December. We have a PDUFA date on this in October of this year. We are excited for the opportunity to allow this product to go out to our customers and to hopefully be a much better and much more easy and painless solution than what we have today to treat this rarely diagnosed disease called keratoconus. What if you could take the next generation of this product, the idea, where it is more targeted and you can basically map the cornea, figure out where those weaknesses are in the cornea, and actually specifically target the treatment in order to strengthen those fibers and get that cornea to even a better state and maybe a better vision outcome.
That is what we talk about here in our third-generation iLink therapy, which is under development today. From an iLink or keratoconus product roadmap, we've spoken about all of these things. We are continuing to really focus in and try to help this patient population that is out there that has this disease in people that you may not know have it, like Steph Curry. He has this keratoconus disease. It is rarely diagnosed. We want to help those that have it to be able to arrest the development of that. I'll talk briefly about iLution. iLution is a cream or a formulation that we have the rights to that allows us to introduce a pharmaceutical into that cream to treat certain diseases.
Today, we'll focus on what we call Demodex blepharitis, which is a disease that has little Demodex mites that crawl on the follicles of your eyelash. Yep, they're nasty to look at. People have them. The ability then to take the pharmaceutical that will treat and, well, it'll kill those little critters, put it onto a little dab of lotion, and wipe that right on the follicles of your eyelid and hopefully get rid of them is highly attractive. We're working through and we'll start a clinical trial on that this year to allow us to pursue that particular therapeutic area. Last, we talk about that Glaukos has the temerity to want to be in the retinal space and to tackle a market that is fully developed today at $10 billion. To do it in, again, a different way.
Today, most of those treatments that are out there on the market are based on anti-VEGFs, which are large protein molecules. Our approach being different is to take a TKI, axitinib, which is a small molecule, put that into a biorotatable pellet, so to speak, and inject that into the eye. In our animal models, we've seen success where the duration of that particular application lasts approaching three years. We've just started a kind of a phase 1b/2a trial on our retina products to get that into humans and to watch and see what happens. Hopefully, that advances along. We can try and change that marketplace as well through longer duration and less burden on the patients. Building the business in stages. Stage one is interventional glaucoma, where we've come a long way with all of our different products.
Stage two, we just talked about with kind of rare disease, keratoconus and what we're doing with that. Stage three is the anterior segment. These are the iLution things that I was just mentioning. We've got, in addition to the blepharitis, presbyopia, dry glaucoma, other things. The phase four would be the retina products that we were just talking about. There is our portfolio. We feel it's one of the industry's most formidable. We're very proud of what we've been able to do and what's left to do. There's still a lot to go. We're excited for the future and what's happening today as well.
I know I'm running out of time, so I'll just hit really quickly on these are the key milestones in 2025 that we're shooting after, all of which are in the clinical area as we move towards some of these newer products and putting them forward. Last but not least is some of the key highlights operationally from the company. We're very proud to have grown a 10-year CAGR of over 20%. The commercial infrastructure that has grown over the last several years, where we have over 300 people now in the commercial area. We have very nice and attractive gross margins at over 80%. We have not only U.S. glaucoma, but we have a large international business now that provides a lot of revenues. We have our corneal health business that we've talked about.
Last but not least is the fact that our balance sheet is strong, been able to generate cash, cash balance of over $300 million. Last year, we were able to eliminate all of our debt. That is no debt in the $300 million. With that, I will say thank you again for listening.
This presentation has now finished. Please check back shortly for the archive.