Greetings. Welcome to Eyenovia, Inc. 1st quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to John Gandolfo, Chief Financial Officer. Thank you. You may begin.
Thank you. Good afternoon, and welcome to Eyenovia's 1st-quarter 2023 earnings conference call and audio webcast. With me today are Eyenovia's CEO, Michael Rowe, and COO, Brent Kern. This afternoon, we issued a press release announcing financial results for the three months ended March 31st, 2023. We encourage everyone to read today's press release, as well as Eyenovia's quarterly report on Form 10-Q for the quarter ended March 31st, 2023, which will be filed with the SEC tomorrow, May 12th, 2023, as well as our most recently filed 10-K. The company's press release and annual report are also available on our website at www.eyenovia.com. In addition, this conference call is being webcast to the company's website and will be archived there for future reference.
Please note that on today's call we will be discussing investigational product candidates, some of which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during the call, Eyenovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks, which are described in more detail in our annual report on Form 10-K. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 11, 2023.
Eyenovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law. With that said, I'd like to turn the call over to Michael Rowe, Eyenovia's Executive Officer. Michael.
Thank you, John. Welcome everyone to our 1st-quarter 2023 financial results conference call. I will start with an update of our recent FDA approval of Mydcombi, how that approval fits within our overall strategy, and then provide a status update for MicroLine. Brent Kern, our Chief Operating Officer, will follow with an update on our manufacturing and commercial readiness progress. We will turn things over to John Gandolfo, our CFO, who will review the financials as well as our partnerships with Bausch + Lomb and Arctic Vision. We will open the call for your questions. During the 1st quarter of this year and more recently, we have made significant progress on all of our stated goals, punctuated by FDA approval of our first product, Mydcombi.
We also received very encouraging feedback from the FDA and believe that we have a clear path forward for our MicroLine presbyopia program. In terms of manufacturing, we are ramping up our activities and will have our Reno facility online next quarter with Optejet Gen-2 clinical batches being produced later this year. Our partnership with Formosa as well as others that we expect to come, will pave the way for additional ophthalmic opportunities that leverage our Optejet technology. I'll begin the call by highlighting our most recent achievement. Just a few days ago, we received FDA approval of Mydcombi, our proprietary combination of a microdose formulation of tropicamide and phenylephrine for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. This is the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S.
Importantly, it is also the first approved product using our Optejet dispensing device. I cannot overstate the importance to our company of this approval. The Optejet is foundational to our development pipeline as well as our partnered programs, and this FDA approval sets a precedent for the future development of additional ophthalmic therapies delivered by the Optejet in other high-value indications. The FDA's approval of Mydcombi provides crucial external validation of our technology and is just the first of many ophthalmic indications that can utilize the Optejet. The approval also marks the formal transition of Eyenovia from a development company to a commercial organization. The management team is extremely grateful to all of our Eyenovia colleagues for their dedication in advancing this program through this important milestone.
Since Monday, we have received numerous inbound calls and emails from ophthalmology and optometry offices asking when they can get Mydcombi. The reasons for wanting the product include the horizontal delivery, the lower drug volume exposure, ease of use for both the doctors and technicians. One doctor said that she planned to modify her office flow so that she could dilate patients right in the waiting room, and she didn't have to have them tilt their heads back. We of course, see this as very encouraging. We plan to introduce Mydcombi later this summer to several key ophthalmology and optometry offices as part of our targeted launch process.
As much as we would like to be out there tomorrow, we need some time to bring our internal manufacturing capabilities, which are more cost efficient, online. By early 2024, we expect to have our facilities in Redwood City and Reno at full production capacity. For now, customers and all of you can find out more about Mydcombi and soon track our launch progress and ultimately hear what doctors and patients are saying about the product by going to the website www.eyenovia.com. I'll now turn to MicroLine, our proprietary topical on-demand pilocarpine-based therapeutic candidate that we are developing for the temporary improvement in near vision associated with presbyopia. As you'll recall, presbyopia is the age-related hardening of the eye's lens, causing blurred near vision.
This is an addressable market representing over 18 million people in the United States alone between the ages of 40 and 55 who will otherwise never wear glasses and have the resources for a cash pay product. Our proprietary market research suggests this could be a multi-billion dollar annual market in the US alone. We recently received feedback from the FDA delineating a clear path forward for this program towards a new drug application or NDA. MicroLine is being designed for use with our smaller and more advanced Gen-2 Optejet device, which has been optimized for in-home use. The machinery to build and fill the Gen-2 cartridge is being installed and validated in our Redwood City facility, and we anticipate running NDA registration batches in the first half of 2024 after satisfying the contracted clinical needs of our partners.
The FDA requires 12 months of real-time stability data on the final packaged product before filing the NDA. We intend to file approximately 10 months after we run those batches. During those 12 months, however, we will not be sitting and waiting. We will be conducting other critical pre-NDA activities, including supportive human factors and clinical work to demonstrate the usability of the Gen-2 device in the target population, as well as measuring patient preference for the Optejet system. This work will be used to support both the MicroLine NDA and upcoming commercialization of the product. An ophthalmic spray in the Optejet device, we believe that MicroLine has a number of unique features that may set it apart from presbyopia eye drop options. The features of our technology may make using the product easier while lowering drug and preservative exposure and potentially improving tolerability.
The attractiveness of the device itself has been pointed to as a highly desired feature in market research we have conducted. MicroLine may also fit better with the business model of many optometrists. Many doctors have a retail portion of their practice where they sell eyeglasses, contact lenses and other products for presbyopic patients. MicroLine could fit well into their paradigm as they may be able to include supporting items such as unique device skins, starter kits, and so on as part of those offerings. We recently conducted market research with 100 optometrists where MicroLine was compared with the five existing or potential presbyopia eye drops that may be on the market in 2025. What we found was that MicroLine was rated number one by the doctors surveyed in terms of meeting the optometrists and their patients' overall needs.
These doctors estimated that MicroLine could capture as much as 1/3 of the presbyopia pharmaceutical market, with the other five eye drops competing for the remaining 2/3 of the market. Should MicroLine be approved, we believe that the Optejet, with its design, ease of use and lower drug volume, distinguishes the product and ultimately patients and their doctors will be choosing from a number of different eye drops or MicroLine, the one and only spray. Turning to our partnering activities, we were very excited to announce in February a development collaboration agreement with Taiwan-based Formosa Pharmaceuticals. This agreement seeks to combine our Optejet with Formosa's unique APNT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics that employ the Optejet device.
Formosa's proprietary innovative APNT platform improves bioavailability and solubility of active pharmaceutical ingredients, allowing more homogenous formulations that may expand our universe with existing and future drugs that could benefit from delivery using the Optejet. We believe this agreement with Formosa will open up new and large market indications for potential expansion of our pipeline and may serve as a model for future partnerships. We're continuing to advance discussions with potential partners that may benefit from Optejet within their own development programs, such as glaucoma and dry eye. Co-development partnerships such as this, addressing large ophthalmic indications with unmet needs, are a key part of our mid and long-term growth strategy. We are continuing to build a large body of data demonstrating the benefits of Optejet over conventional eye drops. In January, we announced positive results from a research study conducted in collaboration with Dr.
Pedram Hamrah, interim chairman of ophthalmology at Tufts Medical Center. This study evaluated the gene and protein expression of Cytokines and Chemokines after treatment with latanoprost, a glaucoma medication preserved with BAK, administered via Optejet versus administered via standard eye drops. In these early findings, the Optejet technology appears superior to standard eye drops in reducing the inflammatory process. The Optejet was found to achieve a therapeutic dose of latanoprost with significantly less exposure to those excess drugs and harmful preservatives that can be achieved using conventional drops. These results were also presented at the Association for Research in Vision and Ophthalmology annual meeting last month. At this point, I'd like to turn the call over to our Chief Operating Officer, Brent Kern, for our manufacturing update. Brent?
Thank you, Michael. With FDA approval of Mydcombi in hand, we've been working with our suppliers to finalize preparations for our upcoming Mydcombi commercial launch. Material order plans are being finalized. We are optimizing processes to align with requests made by the FDA during the review period. Our Redwood City facility, along with our contract manufacturers, continue to support our clinical partners, Bausch + Lomb and Arctic Vision, with clinical supplies being delivered regularly. Additionally, the Redwood City facility has made significant progress in qualifying our fill-and-finish line to support the Gen-2 dispenser platform. This progress has instilled confidence to initiate the design of a high capacity, automated fill-and-finish line, which would support our anticipated demand streams for the Gen-2 device. This state-of-the-art system should be installed in the second half of 2024, with additional qualifications occurring thereafter.
Additionally, our Reno facility continues to make significant progress in establishing base and ejector manufacturing. Recall on our last earnings call, we noted the facility construction was ongoing. These activities have now been completed, and our Reno office staff has taken occupancy. Production equipment is arriving, and installation and qualification activities will follow thereafter. Last quarter, we announced the addition of Enrico Brembilla as Eyenovia's Vice President of Product Research. Enrico joined us in April, and we are already leveraging his expertise in rapidly increasing our engineering capabilities through the identification of new hires, engineering tools, and increased efficiencies, which will be leveraged across our dispenser and an array of drug products. I am genuinely excited about the significant amount of progress we have made over the last few months.
Our operations capabilities are increasing on a daily basis, and the approval of Mydcombi has successfully demonstrated our dispenser platform is a viable technology solution to topical ophthalmic drug application. I'd now like to turn the call over to our Chief Financial Officer, John Gandolfo, to provide a financial update. John?
Thanks, Brent. For the 1st quarter of 2023, net loss was approximately $5.7 million or $0.15 per share, compared to a net loss of approximately $7.3 million or $0.24 per share for the 1st quarter of 2022. Research and development expenses totaled approximately $2.5 million for the 1st quarter of 2023. This compares to approximately $3.7 million for the same period in 2022, a decrease of approximately 32%. For the 1st quarter of 2023, general and administrative expenses were approximately $2.9 million, compared with approximately $3.5 million for the 1st quarter of 2022, a decrease of approximately 15.5%.
Total operating expenses for the 1st quarter of 2023 were approximately $5.5 million, compared to total operating expenses of $7.2 million for the same period in 2022. This represents a decrease of approximately 24%. As of March 31st, 2023, the company's cash balance was approximately $18.5 million compared to $22.9 million as of December 31st, 2022. In addition, the company has the ability to draw down an additional $5 million on its Avenue Capital credit facility through July 31st, 2023, based upon the recent approval of Mydcombi. Licensing programs are an important source of current and potential future revenues for the company, and a major part of our strategy is to complete additional agreements as a source of non-dilutive capital.
In addition to the cash balance I noted above, we have a receivable from our license partners of approximately $975,000 as of March 31, 2023, and they expect a reimbursement payment of approximately $2 million from Arctic Vision for product development expenses in the second half of 2023. Before we open the call to questions, I will conclude with a brief update on our existing licensing programs with Bausch Health for MicroPine in the U.S. and Canada and Arctic Vision for all three of our products in China and South Korea. MicroPine is a proprietary atropine formulation for the reduction of pediatric myopia progression. It has been shown in clinical studies to slow myopia progression by 60% or more. There are currently no FDA-approved drug therapies for this indication.
If left untreated, this can result in retinal detachment, myopic retinopathy, and vision loss. Bifocal, multifocal glasses or contact lenses are typically prescribed to myopic children. Recall that as part of this agreement with Bausch + Lomb, costs related to the ongoing phase III CHAPERONE clinical trial were transferred to our partner and enrollment is progressing as planned. Our agreement with Arctic Vision covers Greater China and South Korea and covers MicroPine, MicroLine, as well as Mydcombi. Arctic Vision is now licensing all three of our current programs in those territories. MicroPine for pediatric myopia, in particular, represents a significant opportunity in China. The Ministry of Education estimates that nearly 53% of all Chinese children suffered from myopia in 2020. Our agreement with Arctic Vision provides us sales royalties in addition to development milestones.
If and when approved, MicroPine could be a significant source of non-dilutive funding for our company over the long term. To date, our license agreements have generated approximately $16 million in license fees, and we have the potential to earn an additional $60 million in net license and development milestones as well as reimbursable expenses over the next four years. Upon commercialization, if our products are approved, Eyenovia can earn significant sales royalties as well. We are also continuing to assess potential pipeline expansion opportunities such as our Formosa agreement, as we believe we could continue to leverage the Optejet technology to address unmet needs in additional large ophthalmic indications. Pipeline expansion was a significant consideration as we were building our new manufacturing facilities. In conclusion, we continue to be pleased with our performance to date.
To summarize our key highlights today, we received FDA approval of Mydcombi, a fixed-dose combination of tropicamide and phenylephrine for mydriasis, and the first FDA-approved product to utilize the Optejet. We received feedback from FDA on our phase III MicroLine presbyopia candidate that provides a clear and efficient path forward for the program that can potentially address a multi-billion dollar annual market in the U.S. alone. We announced a co-development agreement with Formosa Pharmaceuticals. Our manufacturing facility in Redwood City, California, is operational, and our second facility in Reno, Nevada, is on track to be operational in the 3rd quarter. We have continued to expand the body of research on Optejet, as shown by the results from our collaboration study with Tufts that highlighted the significant potential of Optejet to bypass common adverse effects associated with chronic ophthalmic therapy use.
Our licensing agreements with Arctic Vision and Bausch + Lomb are progressing well and continue to offer the opportunity for meaningful development and regulatory milestones as well as line of sight to potential sales royalties, possibly within two years. That concludes our prepared remarks. We would now like to open up the call to questions. Operator?
Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Our first question is from Matt Kaplan with Ladenburg Thalmann. Please proceed.
Guys, good afternoon and, congratulations on the approval of Mydcombi. That was terrific news earlier this week.
Thank you.
Thanks, Matt.
Can you talk a little bit about the commercial rollout? You mentioned some of that in your prepared remarks, but how we should be thinking about that as we move to later this year into next year?
Yeah, I'll take that. Thank you, Matt, very much. We're going to be rolling out later this summer. It's going to be a staged or targeted rollout. The reason for that is that I'm actually here in Reno, in our Reno facility right now, watching them installing lasers and ovens and other equipment. It is much more cost efficient for us to be producing much of this on our own rather than using contract manufacturing. We're going to have a targeted rollout to get the product out in some key offices later this summer. The real push for Mydcombi will come towards the end of this year, going into next year when we have our production facility here fully validated and running.
I would look at it as for this year, it's more to get it into the hands of some very key doctors and get the momentum building for it, collecting names on Mydcombi.com, for example. Then we'll be able to turn everything next year.
Great. Can you talk a little bit about pricing and how that's gonna work? How.
Yeah. Price is $599 for five cartridges. Let's say roughly $120 a cartridge. Each cartridge will support about 75 patients. On a per-patient basis, that's about $1.60. Right now, if you look what doctors are spending on the three eye drops, they're spending about $1.20. It's a $0.40 increase. The customers have told us that when they compare that against the time savings, the convenience, and the overall better situation for their patients, they don't see that as being any hurdle for them to adopt it.
Okay, great. Then just shifting gears a little bit, you mentioned that you received some positive feedback from the FDA on your-
Mm-hmm.
MicroLine program. Can you give us some more details on that feedback and the path forward to the NDA registration?
Right. Our VISION-1 and VISION-2 studies were conducted in the same dispenser that Mydcombi was approved in. And it's a great dispenser. It's perfect for the clinic. We want, however, for MicroLine to be more consumer-friendly, and therefore we want to transition it to our Gen-2, which is more slender and more portable, which fits better with that product. Our question to the FDA was basically, how do you get from Gen-1 to Gen-2, given that they have very similar characteristics in how they deliver the medication? The FDA gave us that information. It involves validating the device the same way we did for Mydcombi. The wonderful thing by having the Mydcombi approval is we know exactly how to do that. In fact, we're doing that right now.
The other thing they were looking for when I mention human factors is they just wanted us to demonstrate that people can actually use the device, which we're also very confident about because they have been using it. There's a little formal study you have to do with that. None of that is going to delay us. The really the big hole in the tent is making the registration batches, the only reason we can't make those sooner is because we have to make atropine batches for MicroPine for our partners at Bausch + Lomb and at Arctic Vision, because they have ongoing clinical studies that we need to make sure that we can supply, in time.
Can you just detail the timeline for those registration batches?
Yeah. We plan to have those registration batches very early next year, and then 12 months real-time stability. As soon as we get the stability results, we drop it into the NDA, and off it goes.
Great. Okay. Thanks. Thanks for that.
Thank you, Matt.
A final question, questions. Can you give us kind of an update in terms of the progress that Bausch + Lomb and Arctic Vision have been making on their programs, specifically, the MicroPine program, and the CHAPERONE phase III?
Bausch + Lomb has said publicly that they are intending to finish enrollment by the end of this year. When they do, it's three years to that the efficacy endpoint. Arctic Vision is going to be starting their study with the generation two device as soon as we get that to them, which is later this year. I don't believe their study is three years. I think it's shorter than Bausch's. Both of these are probably going to finish up at roughly the same time.
Okay, great. Well, congrats again on the approval.
Thank you, Matt.
Our next question is from Matthew Caufield with H.C. Wainwright. Please proceed.
Great. Can you guys hear me okay?
Yes, Matthew. Thank you.
Yes. Great.
Awesome. Thanks a lot for taking our questions, guys, and major congrats on the Mydcombi approval, obviously. I'm curious on the team's perspective on the seemingly negative sentiment for the stock following the approval. What do you think investors could have been missing or misinterpreting about the prospects for Mydcombi or the Optejet opportunity overall? Just separately, I was curious if you could if, sorry, if further financing could prospectively be necessary tied to the internal Mydcombi launch. Thanks again.
John, do you wanna start with that one as it is a bit of a head-scratcher?
Yeah, sure. From an overall financing. It's a good question. From an overall financing standpoint, we have multiple financing alternatives, including, as I mentioned, the Avenue Capital credit facility, where we could draw down $5 million immediately. The reimbursement for clinical supplies from Bausch and Arctic Vision, as well as, partnership milestones or licensing opportunities. We're pretty much working on all of these as of now. We also have traditional financing mechanisms in place. In terms of the financing for the Mydcombi launch, you know, we will not be building up a sales force.
We don't expect our operating cash burn for the Mydcombi launch really to be much different than it was last quarter, where we had an operating cash burn of roughly about five and a half million dollars. We factored that into all of our cash projections. You know, we are constantly evaluating what alternatives we have in terms of financing going forward. With our current cash resources as well as the funds that we know we could draw down, you know, we're pretty confident that we have sufficient cash through the 2nd quarter into the 3rd quarter of next year. I hope that answers your question.
Yeah, very helpful.
Yeah, Matthew. I'll also add. Matthew, I'd like to add because, you know, something else is I think there might be some people looking, if you look at other companies or the history of companies, that they get an approval, and they put together a 100-person sales force, and they start, you know, spending like crazy, basically. I've observed that at other companies, and I've seen that not work. Our philosophy here is we're not going to overcommit ourselves. We can get to our goals being extremely efficient, and as the product grows, we can add resources and add spend to go along with that to keep it, you know, almost like feeding the fire. People may be concerned that with the approval, that there's going to be this huge increase in commercial spend. That's not going to be the case.
Understood. Very helpful, guys. Thank you.
Thank you, Matthew.
Our next question is from Jason McDonald, private investor. Please proceed.
Thanks for taking my questions, guys. Just had a quick one, kind of to your last point there, Michael. When you talk about a hybrid organization having some products in-house and some being outsourced, of course, does the team really view the outsourcing of the technology as the bigger revenue-generating opportunity long term? I mean, obviously you have to wait and see, but I'm just curious where your heads are at, if you think that's really the long-term opportunity?
Thank you, Jason, and thank you for being a shareholder and partner with us. Let me give an example. If we talk about the opportunity in glaucoma. There are many different segments in the glaucoma market. You could be a prostaglandin, you could be a beta blocker, you could be a ROCK inhibitor, and so on. One way to look at this is that by partnering with different companies that have different drugs in those segments, you can actually multiply the number of opportunities that we would have ourselves if we wanted to go into the glaucoma market with a product. We are looking at some of these areas as ways that we can magnify the impact that we can have and get the Optejet out there.
I mean, it's good for patients, it's good for doctors, and it's good for you as a shareholder if we can get this used in more situations. Does that answer your question?
Yeah. makes total sense. Appreciate it.
Yeah. If I could add one thing, Wilson. As we think about the structure, I think that we think about it more as a partnership type of opportunity where we could retain a really large portion of the economics as opposed to a straight-out license type agreement where you're giving up pretty much all of the upside. I think structurally, that's an important distinction to make as well.
Absolutely. Just to follow up onto that point, when it comes to the expenses, you know, long term, are you guys looking to keep this fairly small, like you're saying, Michael, to go in not guns a-blazing, be careful with how you're kind of proceeding with these products to kind of see what the uptake is, and maybe one works better than the other? Is that kind of the intent to stay agile in that sense?
That is exactly it. you know, we will look and see, maybe two years from now, we might have 24 salespeople as we get ready to launch MicroLine. When MicroLine takes off, you know, we can add more, but we don't have to incur that expense today.
Fantastic. Thanks for taking my questions.
Thank you.
Thank you.
As a reminder, it is star one on your telephone keypad, if you would like to ask a question. We will pause for a brief moment for any final questions. Our next question is from Robert LeBoyer with Noble Capital Markets. Please proceed.
Hi. Thank you for taking my call. Congratulations are in order. My question goes back to the financing that was brought up and asked by the previous caller. Is it safe to say... I know we all disdain financing that is of a dilutive nature. Is it safe to say you're not contemplating any dilutive financing, secondary offering or anything in the near future, possibly not till maybe 2024?
Well, I think it's safe to say that what we're doing is we're evaluating all of the opportunities that are out there. You know, we certainly, I will tell you that whenever we think about financing the company, our main focus is to do it in the least dilutive fashion possible. You know, as I mentioned, we do have cash available over the short term from Avenue Capital facility as well as some other receivables that will be coming in. You know, we do a full in-depth analysis. I don't wanna say yes, and I don't wanna say no, but I will tell you that we do have a lot of optionality when it comes to our financing.
Okay. As of right now, you've made no decision to pursue any secondary dilutive offerings. Is that correct?
Well, as of right now, we're evaluating all of the financing opportunities that we have with our partners and everything. There's been no absolute firm decision on a capital raise.
Okay. You know, I don't mean to beat this to a, like, a dead horse, if you do decide on that, how far off into the future would you think that would be?
I haven't really thought about that at this point in time. I will tell you that we evaluate our alternatives constantly. You know, I don't wanna commit to anything like that at this point in time.
All right. It's just a concern a lot of investors have. They, I think I see that as the only hurdle from stopping someone to invest in your company is, it's a factor. It is a factor. They don't wanna, you know, invest in your company knowing that there's a secondary waiting to come to the market within a few weeks or a couple of months. It's an overhang, if there was some assurance there was no overhang, I'm sure everybody here would be a lot more bullish. I appreciate your answer and, do you have anything to add to that or no?
No. I think that's it, that we're constantly evaluating all of our alternatives.
Okay. But this would be probably the last one you'd wanna use, I gather from what's been said so far.
Let me, John, if I can, and correct me if I'm wrong. Our strategy, among other things, is to develop partnerships, as John had mentioned. Those partnerships obviously would bring in some money associated with them. Things like that that are non-dilutive are absolutely our preference. If you're looking, Robert, for what our preference is, it would be to close a partnership or two, and we're working very hard on those, and then do the non-dilutive and save dilutive for the last option. John, would that be correct? Yeah. Look, I think that, I think you're trying to corner us into an answer. What I'm telling you is that we look to, at all times, do things in the least dilutive fashion possible.
Yeah, I understand. I'm glad that you've got capital to last you said until the first or 2nd quarter of 2024. Maybe there won't be a need to do this for a while anyway.
Thank you. Thanks.
All right. You're welcome.
Our next question is from Leonard Yaffe with Stoc*Doc Partners. Please proceed.
Thank you very much. Congrats on the development with Mydcombi and all the other success, Michael, that you've enjoyed since you took over as CEO. It's clear, financing to build out the company for all the potential applications that you have, and that shouldn't be a surprise. It should be welcome. My question is, given that you've got a study, I believe through Tufts, that showed the superiority of Optejet versus drops in glaucoma, which are widely prescribed medications, Mydcombi clearly seems to have benefit both in terms together instead of having to be dosed separately and the ease of use and convenience. Could you discuss perhaps the size of the major ophthalmological markets such as glaucoma, where there might be partnership opportunities?
I think not only would people be interested, but I would expect that the U.S. dollar size that would accrue to Eyenovia could be significant to overcome some of the concerns as expressed by the last caller. Thanks so much.
Thank you, Leonard. If we use glaucoma as an example, there are somewhere between three and four million glaucoma patients actually treated with topical medications in the United States. If you look at first-line therapy, it makes up about half of that, which I believe is about a billion and a half dollars last time I checked. Any good first-line branded medication in glaucoma should expect to make between $150 million and $300 million, that's without really going crazy. Historically, they made more than that before many of them were genericized.
There are a number of partners out there who are looking at this opportunity and saying, "You know, this is meaningful for us, especially if we can convey all of these benefits to patients." We didn't even mention the potential benefits of the Gen-2 to the doctors, where you could track compliance and adherence because of the electronics that are embedded in the Optejet Gen-2. That's what we're looking at, and that's why we're interested in it. I think a good glaucoma medication in the Optejet can bring basically the whole package that people have looked for in this market. Thanks.
Our next que-
Operator, next question.
Yes. Our next question is from Alex Matthews with--. He's a Private Investor. Please proceed.
Yes. Thank you for taking my question, and congratulations on the great achievement. I just want to find out about marketing of the product. I know I talked to my ophthalmologist, and he hadn't heard about the Optejet. You know, how do you plan to get the word out to all the optometrists and ophthalmologists around the country?
Well, thank you, Alex. I'm glad your doctor didn't hear about it because it would mean my marketing person was promotion ahead of what he should have been. Now that we are approved, the next step is we have to get materials approved through the FDA, that takes a few weeks, and then we will be reaching out to various meetings, through email, through social media. If you go onto things like LinkedIn or Instagram-
Yeah.
We have a presence there. We will be able to get the news out. I think also when we start placing the product with some of these very highly visible offices, they all talk to each other, all of the doctors, they will all begin to see it. The fact that your doctor doesn't know now, that's good. I would suspect that he or she will know, six months from now about the product.
Yeah. That's wonderful. Thank you.
Thank you.
We have reached the end of our question and answer session. I would like to turn the conference back over to Michael for closing comments.
Thank you very much, operator. Thank all of you for joining us today. That concludes today's call. We hope we haven't conveyed our excitement on our significant progress and outlook for the coming. We have our first FDA approval in hand. With the approval of Mydcombi, our MicroLine presbyopia program is progressing, and we look forward to updating you on the manufacturing progress as well as discussions with potential future partners. Thank you again for joining us, and we look forward to our 2nd quarter update later this year. Bye-bye.
Thank you. This does conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.