Can someone confirm where, okay, good. Perfect. Thank you very much. Good afternoon. Thank you very much for your patience. We had unexpected technical issues that just got fixed, so we can host the event here live in New York, as well as webcast to our friends who could not join us today. Thank you very much for joining us for this event. We, as you know, we're a publicly listed company, and we'll be making some forward-looking statements, and you can find our disclaimer on the investor section of our website. I'd like to introduce our speakers of today. The first person to speak today will be Dr. Wykoff. Dr. Wyckoff is a chief investigator of the COAST trial, which, as you know, is the first one to read out, our first pivotal trial to read out. He's a clinical advisor to us.
As a full-time job, he's actually the director of research at the Retina Consultants of Texas and has been practicing as a retinal specialist for close to 15 years. Thank you very much for joining us today, Dr. Wyckoff. Mike Campbell is our Chief Commercial Officer. Mike has a very long experience in ophthalmology, having been part of this amazing journey with Lucentis many years ago at Genentech and stayed in ophthalmology over the years in different capacities in different therapeutic areas, but ended up launching two retina drugs, one for Genentech and one for Novartis, a drug called Beovu, or brolucizumab. Mike joined us last year from Viatris, where he was running the eye care part of the Viatris business. I'm Fred Guérard, CEO of the company. I have worked a number of years, too long, in big pharma.
My last job was to run ophthalmology worldwide for Novartis Pharma, which was a combination of Alcon Pharmaceuticals and Novartis Retina, and then did a biotech CEO job in between Novartis and Opthea, which I joined at the end of 2023. This is the agenda of the day. We will be focusing today really on the commercial readiness of the asset, just to give you a better sense of what we've heard from a number of market research pieces that we have conducted between the middle and the end of last year. First, Dr. Wyckoff will cover to us the wet AMD unmet medical needs, as well as the existing data on our product, sozinibrecept. Then Mike will cover this new market research I was talking about, as well as the customer insight that we would like to share with you.
We'll finish with a Q&A section. We will have time at the end to take your questions, if any. We have the potential with sozinibrecept to be the first drug in the last 20 years to really move the vision outcomes for the patients suffering from wet age-related macular degeneration. Despite these amazing anti-VEGF drugs broadly used around the world, still patients experience vision loss or do not recover fully the vision they had when they were diagnosed or before they were diagnosed. We also know today that we are solving for quality of life with correcting vision loss, but we're also solving for quantity of life. There are very interesting correlations between vision loss and mortality, which we think is really quite compelling. We are the first-in-class drug in this anti-VEGF C and D category.
Sozinibrecept is a trap that is intended to be used in combination with existing standard of care anti-VEGF therapies. We have a good composition of matter IP through 2034 and beyond. We have demonstrated phase 2B statistical superiority in combination with standard of care compared to standard of care alone, with an acceptable safety profile. Dr. Wyckoff will cover this data in detail. So we believe Sozinibrecept has the potential to change the life and improve the outcomes of patients suffering from wet AMD. We're expecting the top-line data for two pivotal programs, or two pivotal trials. The first one is COAST, which will read out first in the early part of the second quarter of this calendar year. The second one is SHORE, and SHORE reads out in the middle of this year. And we currently have enough cash to fund operation until top-line data.
No need to mention the market. It's a multi-billion-dollar market, which is still growing, and as the mechanism of action suggests, we are not actually competing with any other therapy out there. We could be potentially combined with all of them when we get to the market, so that's, in a nutshell, our story on what we are trying to achieve. The timelines are the following, so I detailed already the COAST and the SHORE top-line data. We should be getting some news on the manufacturing front pretty soon. We are in the last stretch of manufacturing the drug product of Sozinibrecept, which is the last step before we can file the CMC module with the FDA. We have a Fast Track designation, so we can file the modules as they are ready, so we will press release that when that happens.
We intend to file the last part of the BLA submission in the first half of 2026, and we expect approval by the end of 2026. So without any further ado, I will hand over to Dr. Wyckoff, who is going to cover the clinical section. Thank you.
Hello. It's great to be here with all of you. Thanks for coming out. It's great to be here. I am a medical and surgical retina specialist from Houston, Texas. I've been working with the team with Opthea for a number of years, and I want to try to give a few different perspectives today, so I'll try to give the patient's perspective, my perspective as a practicing physician, and then sort of the clinical trialist perspective. There's a bunch of us in retina that do a lot of trials, and I think this program is unique for a lot of reasons that are worth taking a deep dive into. I'd love this to be a discussion, so later on, happy to take any questions also. Everything on these slides you will have seen before.
I'll try to give the context behind them rather than going through the details. We are very fortunate in the U.S. and around the world to have anti-VEGF therapies that treat patients. We have truly changed the epidemiology of blindness around the country with these drugs. They are unbelievable, and they are fantastic. To be able to use them in patients is a true privilege. I mean, you take patients when they come in, they're scared of losing vision, and you can make their vision better with these current therapeutics. If you look over time, right, 15 years ago, 20 years ago almost, I was giving Macugen. I actually gave the first injection of Macugen in the VA in Miami back in 2006, approximately.
It was a big deal because we took patients with macular degeneration with this downward trajectory of vision loss, and we were able to stabilize their vision. And then very quickly, it transitioned to Lucentis and Avastin, which now made the vision go up, gain vision, and we'll talk about that. And we've been plateaued on a visual acuity gain ever since. And every one of these steps forward has been meaningful. Eylea, brolucizumab, Vabysmo, Eylea HD, and I would add the PDS on here also. All of these have been important steps forward, and happy to dive into the details of all of them. But if you look at the maximum amount of vision gain that we can achieve with each of these drugs, it hasn't changed over the last 10-plus years. And we truly need things that are better for patients going forward.
You can quantify that. If you look at clinical trials and you look at the average vision when patients come into clinical trials, key metric, what is it, I would ask you? What is the average vision if you look back at all these anti-VEGF trials over the years? It's about 20/60, 20/80, 20/100, somewhere in that range. If you gain 10-15 letters, which you might gain in one of the best phase III trials out there, 6-10 is more typically the range, that's great. Patients aren't losing 15 or 20 letters, and they've gained vision. We've got to back up a second and ask, what's that absolute visual acuity the patients are ending with? If they started with 20/80 and you've gained 10 letters, that's great, but you're still in the 20/50, 20/60 range.
If that's your better eye, you still can't drive legally. You still can't do what any of you do on a daily basis, or I do. You still can't read very well. There's a lot of patients out there that are incredibly well served by our current therapeutics, but are underserved because they still have a tremendous amount of absolute vision that is not with them daily. They know it. They're asking constantly for this. This slide characterizes that even more. We think that probably almost half of patients do not achieve significant vision gain defined as 10 letters of vision. Again, that's irrespective of absolute vision. Important to differentiate those. Then about 25% will lose vision over the course of a year or longer. Even more than that, 50%, 75% of patients over time will lose vision for a lot of reasons.
But the one we're focused on here is the one in the middle there. That's 60%. So our current therapeutics are excellent. I don't want to take away anything from them. They're fantastic. But they're incomplete. A lot of these patients still have persistent disease activity. That means persistent bleeding in the back of their eye with the current therapeutics that we have. And so you say, well, wait a minute. Haven't we gotten better over the last 10-15 years? You're saying we're exactly the same as we've always been? That can't be right. And here's some data that's, I think, quite interesting. So we have gotten better at certain things over the last decade. One thing we've gotten better at is diagnosing patients earlier, which is great.
So if you look at the presenting visual acuity of patients with wet AMD when they come in, overall, there's a steady improvement in vision when patients come in. Patients know about it. Optometrists know to screen for it. General ophthalmologists are looking for it. It's a disease that has a lot more recognition in the culture across developed countries, and that's a good thing. And you see baseline vision increasing. And you see that on the side of this graph here with the baseline visual acuity. But unfortunately, the trend is still the same across all these time periods, which is you see this initial burst, this gain of visual acuity of three, four, five letters. And then you see this lingering tail of decrease in visual acuity. So there's two problems here. One is this extended durability problem.
There's a lot of things in the space addressing that. Those are super important, TKIs, gene therapies, a lot of things that I believe in and I'm very supportive of. I work on those projects, and I hope they all succeed. That's really important because that might help us address the tail on these trajectories where the patients gain vision and then they lose vision because they're probably losing vision, one, because they're not getting treated enough. If we have extended durability products, that might help that. They're also losing vision because they have persistent disease activity and need something different. The thing I'd like to focus on is the peak of those humps. What we really want to do is let's gain more vision for patients out of the gate and then maintain that greater vision gain over time.
And if you ask patients, that's what they're asking for. I think the doctor's voice is really important, but the patient's voice is the most important. And if you listen to patients, what do they say? They say, I want to see better. Of course, the patients that are 2015, 2020 that get diagnosed early and do well, they want to get fewer treatments. Absolutely. That's the number one thing they ask for. That's a tiny percentage of patients with wet AMD. The vast majority of patients with wet AMD have lost vision. And they say, I'll do whatever you tell me, doc. I'll take a pill. I'll give myself shots in the thigh. I'll take more shots in the eye. Whatever it takes, more frequent dosing. Just please get me more vision. And that's what this slide shows.
Repeatedly now, multiple different questionnaire-based assessments, patients are overall saying they want to see better. And you're seeing this trend among physicians also. I think for a number of years, doctors talked a lot about burden. And we do. We talk a lot about burden because it's a big deal. Shots repeatedly over time are not easy for patients to tolerate, but they're willing to gain as much vision as possible. So on the left side of this, this is the PAT Survey. This is something that ASRS sends out every year to all practicing retina specialists in the U.S. and ex-U.S. that are members of ASRS. And we get doctors' feedback. 1,000 doctors respond, which is pretty good, assuming there's between 2,000 and 3,000 retina docs in the country. And in 2023, docs said durability was the most important thing in treating AMD. And then there's a shift.
2024, docs are now putting first, both U.S. and ex-U.S., the ability to improve vision gains and maintain vision gains is their number one concern. Doctors are also realizing that these incremental benefits with all these next-generation anti-VEGFs, they're helping. They're definitely helping that durability story, and they're also seeing that things like the TKIs, where we have some in phase 3 trials, and the gene therapies, where we have some in phase 3 trials, some of these things may actually pan out, and we may actually have more durable therapeutics to come, and so doctors are pivoting their perspective, they're pivoting their horizon to say, well, what else do we need if we begin to solve this durability problem? Well, we need something that's going to improve absolute vision.
That's where this program, in my perspective, is actually so easy to actually have a conversation about because it truly stands alone. I would challenge you to come up with another program that's in the same sphere as this OPT-302 molecule, which we now call Sozinibrecept, because there's nothing else in late-stage development that's trying to actually improve that absolute amount of vision that patients are going to benefit from on a daily basis. There's a lot of things looking at durability. This is not meant to take away from those. Again, to repeat what I said before, I hope that they're successful. We desperately need them. We need both of these spheres to be successful for our patients. Let's dive in deep about what exactly is Sozinibrecept. Again, you know all this stuff.
But of course, when doctors and people say VEGF, what are they referring to? Well, at a scientific level, VEGF is actually pretty complicated. There's a lot of different family members. There's a lot of different receptors. But the main thing that people are talking about is VEGF-A, which is, we think, one of the primary drivers of the pathologic process of bleeding and neovascularization that's pathologic in the back of the eye. And it signals through VEGF receptor 2 as the primary driver of that phenotype of exudation in the back of the eye. And again, we have a lot of molecules, a lot of drugs that block that. Thank goodness we do. But we don't have anything that blocks two other key family members in the VEGF family, VEGF-C and VEGF-D.
Critically, these also bind to VEGF receptor 2 because we think VEGF receptor 1 probably plays a more minor role in a lot of these diseases. But it's the receptor 2 that we believe is critical to the pathogenesis and continued activity of these neovascular lesions in wet AMD. And there's quite a plethora of preclinical data on this slide, as well as human data supporting this concept that VEGF-C and VEGF-D may be important in human diseases like wet AMD. And the main graph I draw your attention to, which I think is the most illustrative here, is in the bottom in the middle. And this is among patients receiving anti-VEGF-A monotherapy, so one of the on-label products currently today. And what you see is that the levels of VEGF-C are increasing over time as you give more anti-VEGF-A medications. Why is that? What's going on?
It's an interesting thought experiment here. What's driving wet AMD to begin with? There's some phenotype. There's some change in the eye where there's a hypoxic signal. So VEGF goes up. You block VEGF-A. The eye still has the same driver for a pathologic process to drive neovascularization. And so these eyes are compensating. And they're upregulating other things that can drive VEGF receptor 2, VEGF-C, and VEGF-D in particular. And so it makes sense that we would block that to try to improve outcomes for these patients. So this slide summarizes everything I just said. And then we'll go through the clinical trial data to date and look forward to the phase 3 data. But the concept here is, I think, fairly simple. There's a lot in the space looking to improve durability. And those are important programs. I hope they're successful.
There are very few programs in this space. In fact, I would say this is the only one in late-stage development actually trying to improve the amount of vision that patients gain at an absolute level right out of the gate, and this is the top-line data from the phase 2 trial. So many programs now in retina, it's fascinating, go from a really early-stage program into a late-stage trial. This trial is quite different. We have a very robust phase 2b trial that was a global randomized multi-center masked trial with very robust data. A lot of patients in this trial, over 300 patients, very well-designed trial that gives us a roadmap for what to expect with the phase 3 data. So this is the phase 2 data, which has been published. It's been out there for a long time. Nothing new on this slide.
But remember, with combination therapy with two milligrams, we saw an over 30% improvement in visual acuity. And so there's a lot of ways to digest this slide. And it's worth taking this apart a little bit. Whenever you're looking at a new drug and you're comparing it to a control arm, really important that we understand how well the control arm did. Because we have been fooled in the past in retina with development programs in which a control arm underperforms. We've seen that in many different diseases across retina, including wet AMD. So it's critical to ask, are those gray circles actually representative of anti-VEGF-A monotherapy inhibition? And the answer is a resounding yes. Look at any of the anti-VEGF-A monotherapy inhibition trials out there, and a 10-letter gain is quite robust. In fact, it's probably more than you would expect, I think.
And so I would say that the control arm here performed exactly as you would expect, if not better than what you would expect. And with that context, now you look at a 30% gain. And to me, clinically, that is quite relevant. The second point I would say is you could look at this and say, three letters gain. What is that? That's trivial. That doesn't mean anything. Three letters, come on. And the critical point there is that shifting means is quite relevant on a population basis because it means that every patient has a higher probability of having more vision gain. There's a higher percentage of patients with 15 letters gain, 10 letters gain, five letters gain. Across the spectrum, you've increased that shift. So you've shifted the average, which is quite meaningful if you're the patient that's losing vision from wet AMD.
We've also learned as the field to take safety extremely seriously. If you look back at some of the products that have been approved, there were a lot of comments on podium of no new safety signals. And we've learned to take those comments with a grain of salt. And so I love the fact that the team put these front and center. I think this is critical. We've seen a lot of investment go into a few products recently in this country and then really not be used at all commercially or very little because of very real safety signals, even rare safety signals. So we take this very seriously as clinicians and clinician scientists. And so the two points I would look at on this slide are, first of all, the total ocular treatment emergent adverse events. This is basically anything that happens both severe and less severe.
Then you want to compare that to your control arm on the right in gray there, which is 11.8%. And then you see the combination therapy is the same or lower, which I would not have anticipated. These eyes are receiving two needles in their eye, not just one. And every time you put a needle in the eye, even if there's nothing in the syringe that you're pushing in, there's going to be a risk there of inflammation, of hemorrhage, of pigment in the eye, all sorts of changes. And so to see zero signal of increased ocular emergent adverse events, I think, is quite meaningful to the safety. This also looks specifically at the inflammation. This was on the previous slide also. And again, the inflammation in the combination arms is identical to the control arms or lower across the bar.
You've got to be careful looking at the end values because the number of patients treated in each of these columns is different. That's where the percentages are what matter. So that's sort of the groundwork of the phase 2 trial. We'll talk about some of those subpopulations in a minute. But this has laid the framework for the ongoing phase 3 program. And I've been a part of this phase 3 program since the beginning. And I must say the Opthea team was quite small when this trial began. And they've grown substantially. And I encourage them to grow more. I think they're going to need it. But quite impressive that they pull off this scale of a global trial, 400 sites across nearly three dozen countries and nearly 2,000 patients enrolled treatment-naive wet AMD. That is no small feat. That is a tremendously large, well-designed trial.
The enrollment criteria are almost identical to the phase 2 trial. One of the key principles that we've learned in retina over the years is don't change the enrollment criteria when you go from phase 2 to phase 3 when you have a successful large phase 2 trial, as we did with OPT-302 or Sozinibrecept. Therefore, the key inclusion criteria are exactly the same. They're enrolling all of the angiographic subtypes. They're enrolling classic, minimally classic, and occult lesions. Really important. They're wanting to include all wet AMD patients. The visual acuity inclusion criteria are exactly the same as well. Then the key exclusion criteria are also exactly the same with one notable exception. They left out a small minority of patients with RAP lesions. We'll talk about another subcategory of wet AMD.
But this is where it kind of depends if you're a lumper or you're a splitter. And I would venture to say that most of you guys are splitters like I am. And there's a lot of different phenotypes in Wet AMD. There's probably half a dozen different ways you can talk about subpopulations within Wet AMD. And one of those small subsets are wrap lesions. And those eyes in the phase 2 trial did not perform as well with combination therapy as all the other subpopulations. So it made sense going into the phase 3 trial to drop them out. And we'll look at what that looks like on the next slide. Here's the breakdown of where the number of patients were enrolled across the different countries. And then if you look at the different arms of the COAST and SHORE trials, they're essentially identical except for the comparator.
So COAST is comparing combination therapy with Eylea or aflibercept to Eylea or Aflibercept alone monotherapy. And then SHORE is doing exactly the same thing, but with Lucentis. So Lucentis alone arm compared to Lucentis plus sozinibrecept. And then the sozinibrecept arms either get monthly dosing throughout the entire trial or every other month dosing throughout the entire trial. Primary endpoint is at week 52. And ultimately, these are two-year trials. The other key thing to understand about this trial is that this is a superiority trial. The way that we have improved all of those previous agents from Eylea forward through all those green boxes I showed you before are non-inferiority trials. And that's a really important distinction. Non-inferiority means that you're achieving equivalent visual acuity outcomes, whereas this trial will not succeed if it achieves non-inferiority.
It has to be superior to actually have a successful outcome, and that's what we showed in the phase 2 trials. These are superiority trials, very unique in wet AMD. There are one other superiority trial ongoing out there right now in phase 3, which is quite different for a lot of reasons where the control arm is not exactly what would be done standard of care. The unique situation in this program is that the standard of care arm here is absolutely the gold standard: monthly Lucentis or every other month Eylea after loading doses. OK, so let's take a deep dive into some of the subpopulations in phase 2, and this is where I think some people get confused. This does not have to be confusing, but it's worth going through this so you understand it. Again, we talked about the different phenotypes in wet AMD.
The three big ones on fluorescein angiography are classic, minimally classic, and occult. Where did that come from? Why did we talk about that? That was relevant back in the PDT days. That was one of the first things that was approved for the treatment of Wet AMD 15, 20 years ago. That therapy worked in some subpopulations of patients, but not in other subpopulations of patients. We've seen that with drugs before where you can have better efficacy in one population than another. Every trial in Wet AMD since then has looked at these characteristics of the different lesion types. When you look at the occult plus minimally classic lesions, that represents about 75% of all Wet AMD patients. That's where we saw the most robust outcomes with sozinibrecept combination therapy in the phase 2 trial.
On the left there, you see 50% more vision gain, 5.7 letters on average gained, and that's why that's the primary analysis population for phase 3. The words get confusing, though. It's the primary analysis population. In other words, that's not the patients that were enrolled. Remember, all comers were enrolled on the angiographic subtypes, but there's a subpopulation representing the large majority that will be analyzed first, and that's to maximize the chances of success at the phase 2 trial. It's not to exclude the other population. Because the secondary analysis, the secondary primary analysis, is going to be the total population, which again is all of the angiographic subcategories that we talked about. OK, and then just earlier this month, the team showed the baseline characteristics for the phase 3 trials. Always really important to look at baseline characteristics and compare it to what we know.
Here are COAST and SHORE baseline characteristics on the right compared to the phase 2b population on the left. Critically, I would say everything is very similar, if not stacked in favor of the phase 3 trials. Looking through this, age is mid-70s, what you'd expected for a wet AMD population. Majority are female. The majority are Caucasian. Of interest, there's a slightly higher percentage of patients with Asian descent. This is probably relevant to the PCV subpopulation that we'll talk about in a second. Visual acuity is almost identical between phase 2 and phase 3. Then the lesion types again here are highlighted. I think this is worth looking at in a little bit of detail. Again, there's five different lesion types here that are outlined. Again, these can get confusing, but I don't think they have to.
Occult, minimally classic, and predominantly classic, again, are the angiographic subtypes, which all patients fall into. In addition to that, patients can have wrap lesions. But you can be any three of those subcategories and also have a RAP lesion. That was excluded from phase 3. The PCV population is the same. You can be any of those three angiographic subcategories and also have PCV. That population is slightly higher in the phase 3 trial, which I think probably bodes well for their outcomes because here was the data with PCV on the far right from phase 2. This was actually a subpopulation that showed probably the greatest benefit with sozinibrecept, showing a 13.5 letters gain compared to 6.9 letters with ranibizumab monotherapy. You can see that that population of patients is slightly overrepresented in the phase 3 trial.
So in summary, I think this is a unique story. I think it's one that resonates with patients most importantly. And if you talk to patients, they want to see better. And they want to see better today and tomorrow. So we need agents that truly are more durable. But we really need agents that are actually going to improve absolute vision for these patients. And from a clinical trialist perspective, all the hard work has been done here. These trials have been enrolled. We're going to have data later this year for both of these trials in the very near future. And I think that when these are successful, I think this could have a tremendous impact on how we practice retina every day. So thank you. Happy to take any questions later on. Mike, I'll pass it over to you.
Thank you, Dr. Wyckoff. All right, thank you, Dr. Wyckoff, and good afternoon, everybody. Thank you for joining us. As Fred alluded to, I'll take you through some updated epidemiology claims data, marketplace landscape data that starts to really frame up the opportunity of sozinibrecept. We've also done quite a bit of research, several insights that I'll be sharing as well as we go through this. I should say right up front, most of what I'm going to talk about is US-focused. There are a couple of global comments that I'll make, and I'll make sure to point those out so it's really clear. Also, I should say that anything I talk about from a standpoint of sozinibrecept go-to-market thinking is obviously predicated on an FDA approval.
So with that being said, if I gave you the headlines across the epidemiology claims data work along with the research, here they are. Number one across the board in all of the research we've done with retina specialists, patients, and practice administrators and payers, vision has been the number one category of an unmet need, which fits nicely into the sozinibrecept value proposition. But if you also look at some of the key insights I'll be sharing in more detail in just a minute, we've got a substantial market opportunity here. I mean, you're looking at a U.S. base of $7 billion and growing and about 1.2 million treated eyes. Understanding the development now of sozinibrecept, obviously, it's being developed to be able to use with any anti-VEGF-A therapy. We're not trying to replace anti-VEGF-A. We're not trying to compete.
In fact, we look at it commercially as a partner to all of them. It's a very established and concentrated market. Obviously, within retina for two decades, this buy-and-build model is very established. And it's also a very concentrated market, meaning there is a relatively small number of physicians doing the majority of the anti-VEGF injections. And I'll share that with you. The key insight here is that a commercial footprint can be very lean and very focused to be able to go after this market. We've also got a favorable market access environment. I mean, I'll show you the data in just a minute. But the top five considerations that payers make for coverage decisions in wet AMD is all around vision, which again plays right into the proposition that we're bringing forward with sozinibrecept. And it's also very concentrated with one payer.
I mean, you're talking to more than 90% of these patients sit within Medicare. So I'll share some of that with you. But we've also been developing a very experienced commercial leadership team. It's been said that the best indicator of future success is past success. And I think this leadership team actually exemplifies that sentiment. We've got Anthony Bonifazio, who's our vice president of market access. And we've got Anand Sundaram, who's our vice president of marketing. And collectively, amongst the three of us, we've got a half a century of retina commercialization experience across five successful product launches. So that gives us a great deal of confidence that should we have an opportunity to get FDA approval, should we have an opportunity to commercialize, that we can have another successful launch. So this is the one slide I'll talk about from a global perspective.
So when you look at the branded anti-VEGFs globally and you combine that with the lower-cost options that have been made available globally in biosimilars, you're really looking at a $12 billion global opportunity where sozinibrecept has a chance to be partnered with any anti-VEGF-A. And based on some of the recent epidemiology refresh that we've done along with claims data, you can see there's about 1.5 million wet AMD patients in the U.S. from a prevalence standpoint. And about 1.2 million of those are diagnosed with about nine million receiving treatment. I'm sorry, almost a million receiving treatment. So when you look at the bilateral disease, it's about 35%. So what you see is that it's about 1.2 million treated eyes. Overall, the big takeaway is that we have a prevalence rate that's growing. We have a very high diagnosed rate.
We have a very high treatment rate within wet AMD. It's also a very concentrated market from a prescriber standpoint. About 1,400 physicians make up 80% of all the anti-VEGF injections in the U.S. It gets even more concentrated when you get to the 50% mark. 500 retina specialists make up 50% of all the anti-VEGF injections. Of course, here in the U.S., we've got a private equity structure, business structure within retina that's growing. When we look at the top four private equity business structures here in the U.S., they make up 25% of all the anti-VEGF injections. What this says, again, is that we have an opportunity here to be able to go to market with a very lean and efficient commercial footprint.
When you look at branded products and obviously the entry of biosimilars, what you see very clearly is that this is still a branded marketplace in wet AMD, where physician choice is still in branded products. The biosimilars have had really very little impact on the overall market, and so branded products are still preferred, and branded products are still growing. Now, I mentioned the buy-and-build model that's very established, and I really want to take a minute and explain this because this is where I think sozinibrecept has a non-clinical opportunity. So if you think about this buy-and-build model, and we'll just use drug in this model, practices buy their anti-VEGF-A and potentially sozinibrecept direct. They inventory that product. So they've paid for it up front. They inventory that product in their practices, and they give an in-office procedure of an intravitreal injection.
Once they do that, they can bill the insurance company to recoup the cost of the drug that they purchased. But for using this system, they're allowed to have a margin of 4.3% on top of what they paid for the drug. So if you think about this model, this is why sozinibrecept fits so nicely and actually gives an economic consideration of favorability. Because you're not only doing this per patient for the anti-VEGF-A, you're also doing this per patient potentially with sozinibrecept. So there's an economic consideration here that brings some favorability. I mentioned the research that we've done. I mean, we've had 350 retina specialists that have been a part of our research. We just finished a round of payer research with 19 medical directors or 16 medical directors.
I should say that all of the big eight national payers were represented in this research. It represented 204 million lives within these plans that we did the research. Having been in ophthalmology commercialization for 26 years, this is the largest payer research that I've seen to date. There's some really interesting insights here that I think are going to help guide us as we think about potential go-to-market thinking. We also included practice administrators. These are the folks that run the practice logistically, patient flow along with the reimbursement process. We had 19 practice administrators. All four of the big private equity groups' practice administrator staff were in this research. Again, I mean, across the board, across all of our research, vision was number one for patients, retina specialists, and payers, which falls right into our value proposition with Sozinibrecept.
Again, looking at the vision piece of patients and their preference, obviously, vision was number one. There's a really key insight here. And Dr. Wyckoff talked about this a minute ago. But if you look all the way to the left, injections are dead last. Meaning the key insight is they're willing to get injections and more injections for better vision. And it's not surprising when you think about almost, well, more than half of the wet AMD patients who are currently on anti-VEGF-A therapies don't reach 20/40 driving vision. So I won't spend time here. Obviously, Dr. Wyckoff mentioned this survey with retina specialists. But you can see the change in the trend that he showed where vision is now number one for retina specialists as well.
Now, one of the interesting things we did is we wanted to test the lower boundaries or the floor, if you will, of where a doctor would consider using combination therapy. Is it one letter, two letter, three letter? Is that enough to still use combination therapy, and so if you look all the way to the left, between one and three letters, we had physicians tell us that they would use combination therapy with sozinibrecept on 24% of their patients. Now, obviously, you saw other data that Dr. Wyckoff shared with you where we had substantial gains in very large patient populations, subpopulations, but even at 24% of this market, you're still looking at a billion-dollar market opportunity with sozinibrecept. So there's clinical and non-clinical insights that we were able to glean. Obviously, this 20/40 vision is a big deal.
If you go to our corporate website or our corporate deck on our website, you'll see a subpopulation that Dr. Wyckoff was talking about of occult and minimally classic lesions. By the way, that's about 75% of the total wet AMD market falls into that category. But you'll see in that data that we had a 42% relative increase in patients being able to get to 20/40 driving vision above or in comparison to monotherapy Lucentis. So pretty exciting for patients. From a non-clinical consideration, obviously, the buy-and-build model and injections are an economic consideration for all retina practices. It's become larger, actually. Most retina practices have a larger percentage of their economic considerations built around buy-and-build with biologics. And obviously, vision improvement to a patient is a very straightforward conversation for a retina specialist to have. So let's get to some very interesting payer data.
So as we looked across the payer landscape and conducted this research, what was really interesting here is that the top five considerations that a plan looks at for coverage decision are all vision-related. It's mean improvement of vision. It's proportion of patients achieving 20/40. It's proportion of patients gaining vision. Everything they look at in making coverage decisions in wet AMD is around vision. The Medicare payer landscape, as I mentioned, about more than 90% of these patients sit in this Medicare category. When you look at that Medicare population, it's almost 50/50. So 50% of that Medicare population is what's called Medicare fee-for-service. Really, all that means is that it's a very open, unmanaged side of Medicare where physicians can choose to use whatever they want to use when they want to use it.
And then we have the other side, which is Medicare Advantage, which is a bit more managed. It could be anything from a prior authorization or asking for a low-cost option to be used for a minimum number of injections, something along those lines. What's really, really good about sozinibrecept is that we have an opportunity to get broad coverage across both of these categories within Medicare. And here's what gives us that confidence. So when we talk to the payers about what they look for for broad coverage improvement clinically, they're looking for a minimum of 20% improvement in vision over standard of care, over any VEGF-A therapy. So they're looking for a 20% improvement.
Now, if you go to our phase 2B data and you look at how we performed in our phase 2B data, you can see our total patient population minus RAP lesions was 4.4 letters, so more than a half a line of vision, but it's a 42% relative increase over standard of care, and again, you can see this population of minimally classic to occult lesions, which makes up 75%. I mean, we were 5.7 letters, so more than a line of vision gain with a 56% relative increase over standard of care with Lucentis, and the same with PCV at a much higher relative rate, but 6.7 letters gain compared to Lucentis monotherapy, so this gives us a lot of confidence that pending our phase 3 trial, that we'll be able to get broad coverage across the Medicare.
We also wanted to understand how they were thinking about the use of Sozinibrecept with all the different brands that are available. They went through and looked at all of the brands that are currently available along with the biosimilars. They could see us being used pending, obviously, a label from the FDA. They could see us being used with any anti-VEGF-A therapy. Pricing. We also wanted to understand pricing considerations. Based on the clinical profile that we shared with them, which was the phase 2B data and some of the relative increases, they looked at it and said their expectation on pricing is that we would be priced at parity with the currently available branded anti-VEGF-A therapies. What you see on the slide are the list WAC prices of the branded currently available anti-VEGF-A therapies.
Their expectation is that we would be at parity in this range. When we look at how we start taking some of these learnings now and thinking about it from a go-to-market commercialization standpoint, obviously, vision is going to be a key part of how we commercialize for patients, for physicians, and for payers. We're also looking specifically at opportunities to activate patients as part of our strategy thinking. We're looking at everything from traditional to digital to social media platforms. Believe it or not, social media is a highly growing platform in this Medicare population. We'll be looking at all those kind of executional things to be able to activate patients. We're also looking from a retina specialist standpoint.
We're building strategies now and tactics around how do we communicate this superior vision opportunity for their patients, along with also providing retina practices with the right tools and resources that they'll need to add sozinibrecept and a combination approach to their practice flow, but also making it a very smooth reimbursement for the retina specialist. And lastly, payers. Obviously, we're already engaging payers through research. Post top line data, we will do another round of research. But our plan is to frequently and often and early partner with the payers because we have a true opportunity for very broad coverage with any anti-VEGF-A therapy with the payers. So with that being said, just to put everything back into context, all of the epidemiology, all of the research we've done, superior vision is clearly the cornerstone of the opportunity that we have with sozinibrecept.
Substantial market opportunity here in the U.S., currently at $7 billion with 1.2 million treated eyes, a very established and concentrated market, buy-and-build, and a relatively smaller number of physicians doing the majority of the injections, and a very favorable market access environment that we believe will give us a chance for very broad coverage. So with that in mind, I'll turn it back over to Fred for some closing comments. And then we're excited to take your questions.
Thank you, Mike. So to conclude, we have obviously fully enrolled. We are nearing top-line data readout for COAST and SHORE. Just to remind everybody about the timeline. So COAST will readout early second quarter of this year. SHORE will be around a quarter after that. We will communicate our update in manufacturing. But we are tracking according to plan or a bit ahead of plan in terms of manufacturing. As I said, this is the last piece of information we need before we are able to file the BLA module on the CMC module for the BLA on manufacturing. We did not mention enough that we have FDA Fast Track designation. So we're allowed to not only file these modules as they are prepared, but also potentially be reviewed as fast as 10 months as opposed to the traditional one year.
So that allows us to believe we could be potentially approved end of 2026. And finally, we've built what we think is a world-class team in terms of commercial capabilities. We are very lucky to be able to hire such experienced retina leaders on the commercial side. We've launched already a number of retina products in the U.S. So we can extract this knowledge and this experience for the launch of Sozinibrecept. So I will invite Anthony and Anand to join us for the Q&A. And I will be sorting the questions. So you may get some of them. Just to remind everyone, Anthony is our VP Market Access, and Anand is our VP Marketing at Opthea. And I think we should start by opening the questions to the floor and then maybe take a couple of questions online if we have any. Please.
Yeah. Hi, Dan [uncertain] . So your question is for Mike. Do you get the sense there'll be a correlation between performance?
Mike, do you get the sense there'll be a correlation between performance of the therapy and the price? Or is it really a fixed line at 20% improvement will be the kind of price that you've indicated there?
Yeah. I think payers, there's so many good anti-VEGF-A injections that they're currently covering. When they're thinking about adding another like a combination approach, what we heard in the research is they're really looking for that 20% relative increase over anti-VEGF-A alone as their benchmark. Is this worthy of broad coverage? It wasn't a price thing. I mean, as you saw from a price thing, they guided us towards branded pricing at parity. So it was more about relative increase over standard of care. Yeah.
Oh, there is a mic question here.
Hi. Yigal Nochomovitz of Citi. So this ASRS PAT survey, that's really interesting. I'm just curious, was there anything specific that happened in the landscape that caused this dramatic shift to vision to get promoted to the number one? I mean, it's just an unusual immediate change year over year.
Yeah. It's a good question. The true answer is no. I mean, if you look at the 2023 outcomes, vision was on there. It was like number two, and then small changes in the absolute number of percentages brought them up to number one, but I do think it represents the shift in the landscape of development and what doctors are hearing and what they're seeing in the pipeline. I mean, we have three gene therapies in or about to be in pivotal trials. We have two tyrosine kinase inhibitors in phase 3 trials, so I think doctors have heard a lot about durability for a long time. They've seen an evolution there with Vabysmo, with Eylea HD, with the port delivery system, so they've heard a lot about durability for a long time, and they see a lot more products coming.
And so I think they're beginning to pivot away from that and saying, "OK, these are really useful. This is good for the field. What else is still missing?" Because really, that's what the question is trying to get at. And the wording of the question always changes year to year. But the question is really trying to get at, what do you really care about in the context of everything that's happening that you want to see next? And I think doctors now are kind of realizing, "OK, maybe this durability thing, we're getting there. Let's get better vision.
And then my one follow-up is the chart you showed with the increases in vision over time with the different drugs and then hitting the peak and then the decay. Obviously, you argued eloquently for the increased absolute vision increase. But what about, is there any potential for that decay to be softer with the combo? Or is that something that TBD, but you didn't comment on that aspect of it.
The simple answer is absolutely. I think there's a very clear pathway there. I think there's probably three things driving that decay. So one is incomplete treatments. Doctors are just not giving enough injections because it's hard to sustain monthly or every other month injections forever. That's where the durability play comes into play. More durable agents will hopefully soften that fall. The second thing is dry AMD. So AMD has two major phenotypes, a wet and a dry. We haven't talked at all about the dry. But there's a huge landscape out there of drugs in dry. And we need better drugs there. And some of those patients are losing vision because of progression of atrophy. But the third one, where sozinibrecept fits, and I don't put them in order of importance.
They're all important, that is, probably 60% of those patients, the majority of those patients, have persistent disease activity despite frequent anti-VEGF injections, so even those patients that are getting regular injections, they probably are being undertreated due to these escape mechanisms such as VEGF-C and VEGF-D upregulation.
Thanks.
Yes.
Thanks for taking my question. This is Debanjana from Jones. So I wanted to ask you if you plan on generating some treatment data in previously treated patients, for example, by implementing a crossover design in the open label portion of your trial, given the trial's enrolled treatment naive patients? And I have a follow-up.
Maybe I can take this one. We don't have any open-label portion of the trial. The patients stay for two years on the same regimen all the way in this fixed calendar of injections. We don't have a crossover or some sort of treatment extension plan for the second year. Patients stay on whatever treatment they are randomized into. That's something we would certainly look into after launch. We would certainly be interested to see if we can indeed improve some of these patients after they've been initiated only with an anti-VEGF-A. That's a very good question.
OK. Thank you. And maybe this is for Dr. Wyckoff. So I wanted to know how you would incorporate this therapy in your practice. Do you think you will inject this therapy on the same day as your standard of care VEGF A injections? How long do you think that would extend the visit duration? Or do you think you would prefer to inject this on a different day?
Yeah. Great question. There's a lot of different forces that are going to drive that. Overall, for my personal practice, I think probably a majority of retina specialists over time are going to inject exactly the same day as the anti-VEGF-A monotherapy. The patients there, the convenience of getting them there is already taken care of. They're prepped. They're already anesthetized. It's become routine now to give two injections on the same day for the same eye because of the Geographic Atrophy drugs. Many physicians, when they use those, use them at the same time in the same eye when there's concurrent wet AMD and geographic atrophy. Some doctors, though, do split them up, and the nice thing about this is that you could do that. If that's the patient preference or the physician preference, you could split this up.
But overall, I think given the number of patients that I think could benefit from this, I think the practice efficiencies and convenience for the patients will drive the practice to be same time, same injection. And then your last subtle point, which is a really good one, is that going to increase the duration of the visit? I think the short answer there is that no. The majority of time that patients are in the office is spent on working up the patient and preparing for the injection, not giving the injection itself.
Thank you so much.
There is a question here and then Matt's here.
Hi, guys. Matthew Caulfield, H.C. Wainwright. So one follow-up to Deb's points. With the combo for Dr. Wyckoff, do you think you would start off with the VEGF-A as baseline? Or could you speak to maybe the idea of using the combo as first line therapy for a new patient?
Yeah. Right. Great question, and I think you know, back up there for a second because there's also a good question about the crossover design. There's a lot of, if you look at what happened after the approval of Lucentis or Eylea or Vabysmo, what you see is when a drug gets approved, there's a tremendous opportunity now to do more studies. We're not answering everything with the pivotal trials with any new drug. We're trying to see, in this case, what's the maximum benefit we can get. We're trying to set that ceiling and see how good we can do. And then, of course, there will be a lot of variations of that. Can you treat and extend OPT-302? Or there are some patients that might benefit from more frequent or less frequent dosing.
If you look at the anti-VEGF-A monotherapies, maybe 10% of patients can get a few shots and then never get another injection, and yet those are ignored in many of the trials that we do over the years. You lump a lot of things together in these phase 3 trials, and then you parse them out with subsequent studies over time, so there's a lot to look at. In my own practice, without all those additional trials that I think will come with OPT-302 over time, I think that the two subpopulations that will be the lowest hanging fruit to use this drug in are treatment naive patients, so patients that fit the criteria in the phase 3 trial because we'll be able to help guide these patients and say, look, these are your chances with or without the drug.
Then also those patients with persistent fluid, with persistent disease activity despite regular anti-VEGF-A monotherapies. Those are going to be the two that doctors look at and say, yeah, these are the patients I want to use this in right away.
Sorry, there was a question here. Yeah. Thank you.
Hi. This is Basma Radw an from Leerink. We have a question very similar to the prior question regarding the patient who's going to be selected. When I look at the market share based on the improvement for BCVA, which patient would you prioritize for this treatment? I mean, would you also not prioritize a patient who is 20/40 because probably this patient, you want to maintain their vision? Or would you actually prioritize a patient with greater disease activity? Would you provide more color?
Yeah. It's a great concept. And there's sort of two ways I think about that. One is, I hope I don't have to worry about prioritizing. I hope I don't have three of these shots in my fridge and have to pick that day who gets them. But if that's the scenario where I only get a finite number of these injections in a given day, you're right. I would probably pick those patients with useful vision that could be better in their monocular eye. But I think the broader way I would answer that question is, who are you going to use this at the beginning if you have unlimited access to the drug, which is what's always happened in the past? And in that case, it's the patients that are treatment naive that have vision loss. And that's a huge population of patients.
The one caveat there, if you're like, well, who wouldn't you use this drug in? Maybe a 20/20 eye that comes in with a very fresh conversion to wet AMD where their vision is already perfect. We do see that. Then maybe I would just use anti-VEGF-A monotherapy and do one injection and then observe and see what happens. That's a very unique situation. The vast majority of wet AMD patients that are treatment naive have experienced vision loss. And that's why we're treating them. And so I would say all those patients that I would plan to use this drug in. And it would not just be patients that fit the visual acuity criteria in the trial, for example.
Because, for example, if someone came in with 20/25, 20/32 vision, they would not be enrolled in this trial because the vision criteria makes them have less vision to get into the trial, and the reason for that in the trial is we want to make sure there was enough ceiling to allow 15 letters gain and 10 letters gain, so we exclude the patients in the trial that have really good vision, but even those patients, I would use combination therapy to try to maximize their vision.
Serge Belanger from Needham. First question for Fred and Mike. I think both of your phase 3 trials are looking at two different dosing regimens, once monthly and once every two months. Do you plan on seeking approval for both? And for Mike, does that matter in terms of the payer feedback? And then for Dr. Wyckoff, do those treatment regimens really matter once you get to real-world practice? Or it just gets incorporated in your normal treat and extend paradigm?
Right.
Want to start?
Yeah, I'll start. So from a payer standpoint, it was really looking at the insights around using it with all anti-VEGF-A therapies. And so which they saw based off of our target product profile that we shared with them in the research based on our phase 2b data. So they weren't limiting any of our treatment opportunities. They really saw it as a class effect for all anti-VEGF-A therapies. And one comment that I'll mention that came out in two pieces of the research with the retina specialists and also with the payers, that if our phase 3 data is similar to our phase 2b where we have this patient population, all patients minus RAP, that's 90% of all of wet AMD in the U.S. And then you look at this other subset of patients that make up the occult and minimally classic lesions.
That's about 75% of all the wet AMD market. And so they saw that. And the way the payers responded to that was, we see this as a class effect. And we wouldn't limit the opportunity for any patient to be able to get sozinibrecept in combination.
Yeah. From the clinician's perspective, I think flexibility is really useful when it comes to label. And really what that comes down to is more frequent dosing on label is really useful because doctors can definitely use less frequent dosing. And you can just go longer. And when you go more frequent than on label dosing, that's where it's a problem with payers and insurance carriers. So from an ideal physician and patient perspective, you would get on label monthly dosing. And then I could use it every six weeks, every eight weeks, every 12 weeks, whatever was appropriate for the patient. And I think physicians are going to adapt just as they have with anti-VEGF-A monotherapies to the given patient. So some patients need monthly anti-VEGF-A monotherapy indefinitely. Some patients can go every 12 weeks, every 16 weeks. It's highly variable.
I think we would probably use the combination therapy at the same frequency as the anti-VEGF-A monotherapy.
Any other question in the room? Yes. Back here.
Thank you. Eka Gigauri on behalf of Andreas Argyrides at Oppenheimer. Mike, you mentioned branded treatments are still preferred in general over biosimilars based on the research. Do you think this could still be true for a combination treatment potentially with sozinibrecept? And can you talk about the anti-VEGF-A biosimilar co-formulation program that Opthea has going on? Thank you.
Sure. I'll take the first part of that. Fred, maybe you want to talk more about the co-formulation program. But clearly what came out in the research is that they agreed. Of course, here's the thing with payers. They're always going to cover you to label. So based on our FDA indication and label, what was clear that came out is they would cover us to label. And so in that environment, obviously any anti-VEGF-A so it goes back to what I said earlier. The way we're thinking about this commercially is that we're not competing with anti-VEGF-A. We don't have a preference to a brand. We don't have a preference to a biosimilar. Our design of our program is to be used with any anti-VEGF-A. And the payers agreed with that.
Now, from a retina specialist standpoint, we see it as a big opportunity to give the retina specialist the flexibility to really do what they want to do. They can use their preference, whether it's a biosimilar or whether it's a brand. You can see the brands are still growing and the biosimilars really aren't. So our assumption is that most of the Sozinibrecept use will be used in combination with a branded therapy. But they could use it with a biosimilar if they chose to.
When it goes to the co-formulation, so we are now in stability testing. So we are basically mixing an anti-VEGF-A and sozinibrecept together and looking into what conditions these co-formulations, these two biologics would be stable. We're going to report that whenever we have data that we can show. As you can imagine, it's quite challenging to stabilize two different molecules in the same vial. But we think it's actually a useful option for some clinics that would prefer to inject the two drugs in one injection. We think it will be actually very useful ex US more than in the US simply because the flexibility that the Medicare Part B reimbursement system in the US offers to the clinics to purchase different anti-VEGF-A's now that many biosimilar options are on the market or will be on the market tomorrow.
We keep that flexibility having sozinibrecept as a monotherapy for the clinics to select which anti-VEGF-A they want to use. But obviously, in other health care systems, it could be useful to have the two drugs premixed in one vial. So we're already working on this. Any more questions in the room?
Oh, thanks for the presentation. This is Claire from Jefferies. So can you remind us of the phase 3 pivotal study? Is there any statistical design for the superiority? And also just want to get some clarification on the reimbursement. Are there any reimbursement differences between dosing, doing a second injection for one eye versus bilateral eyes and in one day versus in two separate days? Thank you.
Yes. So maybe I'll take the first question. You will take the reimbursement question. So we have power at 90% to detect a difference between the comparator arms and the combination arms. So we're very, very well powered in the clinical trial. Hence the size of the clinical program. So we don't think the power will be more than enough to detect a difference between the different treatment arms. You may want to cover the reimbursement injection fee.
Yeah. I think what would be helpful is we have Anthony Bonifazio in the room. He's our VP of Market Access. He actually conducted the research with the payers around reimbursement. So Anthony, why don't you make some comments on that?
Sure. Turn around and face everybody.
So from the research, two areas of research that we conducted. One is with payers, one with practice managers. Very robust research. And what we heard very clearly was as far as the reimbursement for the product, two products, precedent has been set to Dr. Wyckoff's point. Right now, when there's an injection, it could be in the same eye. It could be bilateral injections, one with an anti-VEGF therapy, one with an anti-complement inhibitor. What we've heard from our practice managers and from payers is both of those products are getting reimbursed appropriately. I say that with the caveat they have to be coded billed correctly. And a lot of that is on the human side. As far as injection fee, again, those precedents have been set as well.
And what we're looking into though actually for sozinibrecept is in the oncology space, combination therapy is very common. So we're looking into a lot of payer policies right now that endorse based on label combination therapies to where second infusion, second injections are fully reimbursed. As of right now in the retina space, that is not precedented. But that's something that we are digging into and hopefully get more clarity on moving forward. Thank you.
Thank you, Anthony.
Yes, sir. Eka from Oppenheimer. I just had one follow-up. So what is the exact procedure for the way this primary analysis will be analyzed? Because you've got the four-week, the eight-week, and then you're saying the primary analysis population is the occult and minimally classic. So is it, I mean, how do you do it? Is it the eight-week first, the four-week first, or are they parallel?
It's parallel. So we split the alpha. It's parallel testing and it's a hierarchical testing when we go for what we call biomarker positive, which is occult and minimally classic lesions, and then all comers. And we do that for every endpoint. It's two testing per endpoint.
OK. And then one more for Dr. Wyckoff. If I could ask you to speculate, let's assume that both the COAST and the SHORE work and they hit their endpoints. But obviously they're paired with different VEGFs. So do you have a view as to which of those trials may result in the more compelling data? Obviously, some say Eylea may have a little bit different properties than Lucentis. Do you have a view there as to which would be the more compelling data set, assuming they both work?
Right. It's an interesting hypothetical situation, and I agree with Mike and the concept that the ideal situation for us as practicing physicians and patients is that they're both successful. Because that will then sort of lead to a very natural story of this is parallel with any anti-VEGF-A monotherapy. That's sort of the ideal situation. In that context, as you're saying, which one I think could be more positive, I don't know. It's all speculation. I mean, all of the direct head-to-head outcomes between Eylea and Lucentis have shown equivalent visual acuity gains with one exception in a different disease state. In DME, there's a protocol called Protocol T, which was a population of DME patients. In that study, patients with worse vision and more active disease appeared to do better.
Definitely through one year, the superiority was a little less pronounced at two years with Eylea over Lucentis, and that appeared to be because of a greater drying effect of Eylea in that population.
Thank you. Any final questions from the audience in person here?
Fred, if not, there's one question that came in from those participating virtually, and it is, do you expect payers to restrict sozinibrecept to be used with biosimilars to save cost on combination treatments?
Yeah. So I'll take that, Fred. So some of the payers did mention the fact that they would look at considerations with biosimilars. But they didn't talk about it in terms of being able to restrict Sozinibrecept's clinical profile for patients or injections for patients. It was more in terms of for the side of Medicare that actually manages the class that I referred to earlier, that Medicare Advantage side, where they may put a step at it or they may require a patient to get an initial low-cost injection. They would use Sozinibrecept with broad coverage for those initial injections before a physician could use their preference to move to a branded product. But it wouldn't drop off for Sozinibrecept at that point. So that was the considerations that they talked about in the payer research.
Thank you. Any other question online, PJ, or?
That's all we had in the queue.
OK. Very good. I would like to thank everybody for coming today and joining us, whether physically here in New York or online. I hope it was an informative session. Of course, we're available for any question you may have after this day. Thank you very much.