EyePoint Pharmaceuticals at RBC Conference: Insights on Duravu’s Promise

On Friday, April 4, 2025, EyePoint Pharmaceuticals (NASDAQ: EYPT) participated in the RBC Inaugural Virtual Ophthalmology Conference, where CEO Jay Duker outlined the company’s strategic developments. The discussion focused on EyePoint’s lead product, Duravu, and its potential impact on the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). While the company highlighted strong financial stability, challenges such as market competition and regulatory hurdles were also acknowledged.

Key Takeaways

• EyePoint has nearly $400 million in cash, providing financial stability until after the wet AMD trial results.
• Duravu’s unique delivery system aims to reduce treatment frequency, addressing a significant unmet need in the wet AMD market.
• Enrollment in phase three trials for wet AMD is progressing rapidly, with plans for DME trials in 2026.
• EyePoint’s US-based manufacturing mitigates tariff risks, and prior FDA agreements support a stable regulatory path.

Financial Results

• EyePoint reported having just under $400 million in cash as of December 31, providing a runway extending to about a year after wet AMD trial data becomes available.

Operational Updates

• Manufacturing: EyePoint’s facility in Northbridge, Massachusetts, can produce over one million DuraCert inserts annually.

• Clinical Trials:

- Active enrollment in two phase three pivotal trials for wet AMD (Lugano and Lucia) is underway, with record-setting progress.

- A phase two trial in DME (Varonis) has been completed with positive results.

• FDA Interactions: The company has established agreements with the FDA on the wet AMD pivotal program, ensuring stable timelines.

Future Outlook

• The DME program plans to meet with the FDA by the end of the current quarter, with the initial trial start anticipated in 2026.
• EyePoint expects the DME market to expand if the majority of eyes can go six months or longer between treatments.

Q&A Highlights

• Tariff Impact: EyePoint’s US-based manufacturing and API production exclude it from tariff risks.
• FDA Layoffs: The ophthalmology division remains responsive, with stable timelines due to previous agreements.
• Efficacy Expectations: The primary endpoint agreed with the FDA is non-inferior visual acuity with a delta of -4.5 letters.

For those interested in more detailed information, please refer to the full transcript of the conference call.

Full transcript - RBC Inaugural Virtual Ophthalmology Conference:

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Good morning, I’m Lisa Walter, senior biotech analyst here at RBC Capital Markets. Thanks for joining us at RBC’s inaugural ophthalmology conference. This morning, we have EyePoint’s Jay Duker, who’s president and CEO, and Ramiro, Ribeiro, who is the CMO. Jay, Ribeiro, thank you so much for joining us today.

Jay Duker, President and CEO, EyePoint Pharmaceuticals: Thanks for having us, Lisa. It’s great to be here.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Excellent. Well, Jay, maybe we can just start off. Can you give us a brief overview of the company, the DuraCert technology, and what stage of development the wet AMD and diabetic eye disease programs are in?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: Of course. So EyePoint is a phase three clinical stage biotech company, and we’re well positioned to be the leader in sustained release drug delivery to the back of the eye. Our lead product is called Duravu. Duravu is the small molecule tyrosine kinase inhibitor vorolanib, in our patented delivery system, which is called DuraCert E. DuraVu is currently studied in two indications.

The first is wet age related macular degeneration, and we are currently actively enrolling in two identical near simultaneous phase three pivotal trials in wet AMD. The enrollment is going incredibly well. We also completed a phase two trial in diabetic macular edema and have an active program in DME. The company is is well positioned from a financial perspective with just under $400,000,000 of cash as of December 31. And that cash runway gives us, we hope and expect, close to a year after data from the wet AMD trials.

So from the perspective of, potential, from the perspective of, safety of our product, from the perspective of the data that we’ve gotten from our two phase two trials, we feel that we’re in a in a terrific position with a very large potential market in both wet AMD and DME, in a very derisked product at this point.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Got it. Thanks for that, Jay. And, you know, just since it’s on top of everyone’s mind, given the recent news that The US will be imposing a 10% universal tariff across foreign made goods and reciprocal tariffs, You know, could this be an opportunity for EyePoint given the manufacturing facility is based in The US?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: No. I I think that at this point, so far at least, pharma has been excluded from the tariffs. But but even if the tariff does start to involve pharma, we are in a very good position. Our API vorolanib is sourced in The United States, and we have our own commercial manufacturing facility that we opened last fall. It’s a 41,000 square foot state of the art manufacturing facility located in Northbridge, Massachusetts, which is about forty five minutes west of our headquarters in Watertown, Massachusetts.

And when it is fully up and running, we have the capability of making over a million DuraCert inserts per year, which should be enough to supply, if successful, the global market for our product. We control the manufacturing ourselves. There’s quite a bit of technical know how that goes into making these inserts, and so we think that we’re in a very good position with respect to the global markets given how we control our destiny with respect to manufacturing.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Got it. Jay, that’s super helpful to have the clarity there. And, you know, just another event that is topical and affecting the pharma industry, You know, what impact will the recent layoffs at the FDA have on drug development? How is how is EyePoint thinking about this?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: Well, from the to the first part of your question, you know, I I wish I had a crystal ball and I could answer the question for everybody. I think it it it’s obviously still unfolding, but we feel like we’re in a very good position. First of all, you know, we continue to interact with the FDA about various things, and what I can tell you is the ophthalmology division continues to be highly responsive in giving us timelines that are unchanged from the prior timelines that that we saw before this administration took over. Also, with our wet AMD program, I’d like to remind everybody that that we had actually had a type c meeting with the FDA in 2022 to discuss the pivotal program and had come to an agreement around that pivotal because at the time, we were contemplating going directly to pivotal from our phase one. We eventually decided to do a more traditional phase two, which again was very productive.

It it really taught us a lot about our drug and how it works, and, you know, obviously, it was a highly successful phase two. But then we with that data, we had an end of phase two meeting in 2024 with the agency. And so we have, we believe, very solid written instructions and agreement over the pivotal programs so that I we think that will be very helpful in the future should there be changes in new people coming into the FDA. I think it was it would be more likely than not that they would refer back to the written minutes and the agreements that we’ve already had. So we think we’re in a very good position from an agency perspective.

And remember also, our wet AMD trials are, you know, what I refer to as, you know, tried and true. We’re doing two identical non inferiority trials. That’s the way the last five approvals in wet AMD have been done with non inferiority trials, and we think that’s also very derisking because the the two identical trials, you know, obviously the same enrollment criteria, the same patient population, the same statistical analysis. So all of those from an agency and regulatory perspective, we think are derisking.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Alright, Jay. That that’s very helpful. Maybe before we we dive in more into, DERVIEW and and and the data and ongoing, phase threes, Just maybe a bigger picture question on the wet AMD landscape. The anti VEGF monoclonal antibodies, this is a $15,000,000,000 plus market today. About two thirds of this revenue is attributed directly to wet AMD.

You know, despite being one of the most successful therapeutic franchises today, there remains an unmet need in, this disease area due to the treatment burden faced by patients. So Jay, just wondering, can you remind us how is EyePoint looking, to solve, the treatment burden for patients who are, reliant on anti VEGF, and how could DERVUE change current standard of care?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: So, once again, this is at the essence of what we’re trying to do, which is improve patients’ lives, those who have serious retinal disease. And as a retina specialist and a practicing retina specialist, you know, I’m in a position to say that I really live this almost on a daily basis. So as you pointed out, the ligand blockers have been very successful. The efficacy is very good, the safety is very good, but what they lack is durability. Wet AMD is one of the few chronic diseases that’s still treated in an acute staccato fashion and still treated with a single MOA.

TKIs and vorolanib, they work at the receptor level. This is a different mechanism of action. And because of our unique delivery system, we can deliver the small molecule with what’s called zero order kinetics, which means after initial burst of the drug, in about two to three weeks, we get to a steady state and we maintain that steady state for at least six months in humans. We think in humans by about nine months, the drug is completely spent from the initial inserts. But this consistency of drug release, we think can make a big difference in how patients do.

One of the problems with chronic disease of chronic any chronic disease and certainly wet AMD is that patients, because of the need of continued therapy, they drop out. They can’t make visits, they miss visits, they lose vision. With continuous sustained release for six to nine months, you can actually improve that by accounting for missed visits or late visits and the fatigue that patients can have over many years of having to come in with such frequent injections. So that we believe that our drug will improve the outcomes in wet AMD, and we believe we’ve got the potential to improve patients’ lives by giving them the flexibility to go longer between injections. So patients from our phase two data, two thirds of them could go six months between, injections, and fifty percent went a year with just our drug and no further therapy.

We have reasons to believe that in the phase three, we will do even better than that. But once again for us, a supplement injection with Eylea is not a treatment failure. If we can reduce the treatment burden for a patient, but it might require our drug plus one or two Eylea or Lucentis or biosimilar supplements during that time period, but it represents a significant reduction in their prior treatment burden. I think the patients and the physicians would be very happy with that. So that the idea of flexibility to reduce the number of visits and reduce the treatment burden is what we’re really gonna offer.

Now I have to add, there we have the potential to do even better than just be a longer acting medication. Because of the new MOA, it’s conceivable that some patients may do even better with a receptor blocker than a ligand blocker. We’ve seen some evidence of that and certainly in our DME trial, which we can talk about. But we also should have an anti fibrotic effect. We block PDGF, which theoretically should block fibrosis.

And when you ask retina physicians why do patients in the long term lose vision in wet AMD, The number one answer is the patients stop coming in for the injections. The number two answer is they get geographic atrophy, dry AMD. The number three answer is fibrosis. So we’re in a position to take care of two of those three long term reasons why wet AMD patients lose vision. So if in fact we are anti fibrotic, that’s something that the ligand blockers can’t offer.

In addition, we’ve done preclinical studies, animal studies, that suggested that vorolanib may be neuroprotective, meaning in patients with retinal detachment fluid under the retina, animals that got vorolanib showed that there was less loss of the photoreceptors, and if we can show that also in patients, I think that would be another reason why doctors would really be motivated to use our drug because in the long term we may be protective to the outer retina. So I think again we’re in a position to offer patients and practitioners flexibility to go longer between visits and injections, but beyond that, the second MOA, the anti fibrosis, the potential for neuroprotection is something that really may push us into a position where doctors have to find a hard reason not to use us.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Jay, thanks for that. And I just maybe want to dive in. You mentioned this anti fibrotic effect, as something that could be differentiating, from a tyrosine kinase inhibitor versus, anti VEGF. How how could you go about measuring an anti fibrotic effect? And is it is this something that you’ve explored in your, clinical studies?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: So, again, a good question. And the answer to that question is that ancillary testing in all these wet AMD trials and DME trials are done frequently and at, you know, every visit patients get an OCT, optical coherence tomography, which is a cross sectional, quantitative measurement at the center of the retina. Fibrosis can be detected on an OCT. It can also be detected on a fundus color photograph, which we do periodically, and also on fluorescein angiography, all of those together. And so like any large clinical trial, we have what’s called a reading center which looks at these ancillary tests and rates the fibrosis at the beginning of the trial and a year into the trial, and again we’ll do it at year two as well.

What we hope to show is that for eyes that have progressive fibrosis, our drug shows a difference between the fibrotic effect versus the Eylea control. So we there will be quantitative ability to to show that, and we hope that we can show that as a differentiation between our drug and the ligand blockers.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: And Jay, for fibrosis and since you’re looking at patients quite frequently trying to assess the effect here of the TKI, Should we be anticipating, versus the Eylea arm, like a rate a slower rate of decline in terms of fibrosis? Should we be looking at perhaps, stability with the TKI versus decline with Eylea? Or is there potential to even reverse fibrosis in, TKI treated patients? How how should we think about that?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: So I think it’s really, again, a slowing down of the fibrotic process so that the fibrosis can be measured quantitatively in an area. And, you know, eyes that don’t have fibrosis at the beginning can develop fibrosis, eyes that have fibrosis can get more. And so that we’ll be looking quantitatively at the area of the fibrosis as it enlarges to see if there’s a difference between the treatment and the control groups. Reversing a fibrosis, I don’t know that our mechanism of action is going to allow for that. It’s conceivable that blocking PDGF may allow for that.

There were some early trials done on coronary vascularization that was a type two where there’s did show some reversal of that. The type of coronary vascularization is is rated on an OCT, and type two CMV used to be much more common. And nowadays, since wet AMD is being diagnosed earlier, most of the coronary vascurgations we see are type one, which are a little less associated with fibrosis. And so while that may be possible even in this population to show reversal of fibrosis, that that’s not our expectation. But I do think in the end, it’s all about visual acuity.

Now fibrosis is a long term problem, but I believe my colleagues will accept that if we show significant decrease in fibrosis at one year, that will eventually show up as improved visual acuity in the long term.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Jay, just digging in here a bit more, are you potentially thinking you could explore having an anti fibrotic effect on the label should DERVU get approved? Is that that something that could end up in the clinical section of the label as a as a differentiating feature? How are you thinking about that?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: I think that’s certainly possible depending on what the results are. Yes. It is an endpoint that we’ll be looking at and if it’s achieved then I think we will be able to put that on the label.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Got it, that’s helpful. Well, you already had touched a little bit on the phase two data in terms of efficacy. Just wondering if you can remind us about, what the safety profile has looked like, with DuraVu across, you know, the one hundred and ninety plus patients that EyePoint has treated to date.

Jay Duker, President and CEO, EyePoint Pharmaceuticals: Sure. So let me start out with the preclinical safety. We have not found a maximally tolerated dose of Verrolandin in animals, and we’ve done a a scaled dose in rabbits 10 times higher than what we put into humans or could put into humans with no toxicity seen. We have also not found a maximally tolerated number of inserts. We’ve had up to six inserts in the rabbit eye simultaneously with no toxicity.

So from a preclinical perspective, we’re very comfortable with both furolanib and our delivery system. Now remember also the delivery system has been used in tens of thousands of patients prior. It was a little different. It wasn’t erodible. The non erodible for previously treated FDA approved products had a polyamide shell around the core of the drug.

That polyamide shell is inert, but it never goes away. So that made the previous inserts non erodible. We took away the polyamide shell for Derview to make it completely bioerodible, but that also gives us comfort that the inserts in the matrix that’s used in the insert, which has been in tens of thousands of patients, is safe. And finally, as you mentioned, we put the review in over one hundred and ninety patients with at least a year of follow-up, and we’ve had no ocular or systemic SAEs reported due to our product. The AEs have been basically one would expect in a wet AMD population for the most part they’re grade one or grade two from the phase two trial and they’re things like subconjunctival hemorrhage, which is, know, broken blood vessel on the white of the eye from the injection, which is common with any injection.

And of course we had patients who in the phase two had AEs reported as progression of wet AMD, and some of them did progress and required, you know, supplement injections in that in that regard. But as you look at the AE tables, you know, again, we, you know, just had the DME trial reported out. The there were the the number of AEs in the DME trial was exceedingly small. So from a safety perspective, we’re very comfortable with Duravu. We’re very comfortable with vorolanib.

And and as I said, so far so good. We believe that the the safety so far has been terrific.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Got it. Thanks. Thanks, Jay. And maybe let’s talk about the LuganoLucia trials. You mentioned these are two ongoing phase three non inferiority studies.

I’m getting a question here from, the audience. Can you remind us what the rescue treatment criteria is?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: Sure. But just to give if you like, if you don’t mind, I’ll give you a little background. Sure.

non inferiority trials enrolling approximately 400 patients into two arms. The first arm is the treatment arm which is two point seven milligram of our insert. This is again inserts that are 94% drug in the phase two we used lower payload inserts that had about five times more matrix in them. The patients are about seventy five percent will be treatment naive, about twenty five percent will be previously treated. All patients get randomized on day one.

On day one, they all receive two milligrams of EYLEA, they receive another two milligrams of EYLEA on week four. At week eight they receive two milligrams of EYLEA and thirty minutes later they either receive, Duravu or they receive, a sham injection for masking. The patients are then watched monthly, every other month the Eylea arm gets another Eylea, the dura view arm gets a sham, and at month eight, six months after the first dura view, the patients will get a second dura view. The primary endpoint is non inferiority change in visual acuity combined weeks fifty two and weeks fifty six. Both arms can be rescued.

This is a little bit of a unique aspect of our trial design. The physician who determines if an eye meets rescue or supplement criteria is masked to which arm that eye is in. The supplement criteria in Romero Ribeiro, our CMO who’s on the call as well, was instrumental at really studying the phase two to determine which rescue criteria really mattered. So we’ve really simplified rescue down to a drop in five letters from best on study due to wet AMD along with 75 microns of new subretinal or intraretinal fluid due to wet AMD. So the eye has to have both of those simultaneously to meet rescue criteria and if they do we want them to be rescued.

We don’t want patients to lose vision. We want them to have that protection of of a supplement injection in either arm if they need it. And I, you know, go back to either arm. Remember, the EYLEA arm is gonna get treated every other month. In the real world, about twenty percent of patients still need monthly treatment.

So clearly, some of the patients in the control arm will be relatively undertreated, but those eyes will also have the ability to be rescued. And so in the end, when we compare the rescue numbers, it’s going to be a comparison between our arm, the treatment arm, and the control arm. In addition, we have one of the rescue criteria, which is new hemorrhage due to wet AMD, and and that is gonna be adjudicated along with the help of a rescue monitor. The reason we added the rescue monitor to the hemorrhage is that when we looked at the hemorrhages in phase two and there were nine hemorrhages across the three arms, It turned out that six out of nine, they either weren’t a hemorrhage or they weren’t due to wet AMD. So we wanted to be sure that the eyes that had active disease get rescued, but the ones who did not have active disease do not.

Hence, the rescue monitor with respect to hemorrhage. We no longer allow physician discretion to do a rescue. We did in the phase two, and it turned out about twenty percent of the rescues didn’t meet any criteria, and so we wanted to eliminate that in the phase three. So that’s the supplement criteria, and and we’re quite comfortable that this will accomplish the goals that we like.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Jay, just a couple of questions on the the rescue criteria. Is there no option to retreat just if there’s presence of fluid? You have to have both, BCVA reduction and presence of fluid. Is that correct?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: That’s correct. And so one of the things that, I think people should be aware of, and this is a little subtle, but we retina specialists, we use OCT in the presence of fluid as a biomarker for activity. When in reality, what a patient cares about and what a doctor cares about is visual acuity. As it turns out, eyes that have a little bit of subretinal fluid in wet AMD, there’s multiple trials that show that the end result for visual acuity is actually better in an eye with a little bit of subretinal fluid as long as it’s stable than eyes that have no subretinal fluid. So that implies, and I think it’s true, that fluid in and of itself is not necessarily a bad thing in wet AMD.

And toleration of stable small amounts of fluid is now something that is, I think, becoming acceptable. Because, of course, there are certain eyes that you can’t get rid of all the fluid. So fluid alone, especially subretinal fluid, does not necessarily mean a drop in the vision. And, therefore, going back to that question, fluid alone is not a rescue criteria for us because, ultimately, our primary endpoint is visual acuity. It is in fluid.

We care about fluid, and we especially care about fluctuations in fluid, which again, since the topic was brought up, I’d like to go back and remind people of our results of the the fluid stability in the phase two. While the control group every other month EYLEA had a typical sawtooth pattern that you see with every other month EYLEA, meaning the two months after the last injection the eyes were gaining fluid. The DuraVu eyes did not have a sawtooth pattern, they were rock stable.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Thanks, Jay. That’s that’s really helpful. And I do have a couple other questions here from from being emailed into me. Are there any limits to the number of rescues patients in the treatment arm can have? You know, once they get one rescue, are they still eligible for more?

Or would this be triggering or a safety issue to the FDA if a patient in the treatment arm is getting multiple rescue injections?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: Yes. So there is no limitation. Anytime they meet a rescue criteria, they should be and we hope will be rescued. There’s no limitation per se, but the rescues are handled with sensitivity analysis. It is a statistical way that they’re handled, and that that it it would make sense that an eye that has multiple rescues would be handled differently than an eye that only had one or that an eye that had none.

But that’s a, you know, statistic sensitivity analysis that will be done after the totality of the data is there.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Jay, just on the non inferiority BCVA primary endpoint, do you have a written agreement with the FDA that the margin is, negative 4.5 letters? Or yes? Okay.

Jay Duker, President and CEO, EyePoint Pharmaceuticals: We do. Yes. We we had that written agreement at the type c meeting in 2022, and it is reiterated at the end of phase two meeting in 2024, minus 4.5 letters.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Got it. Got it. That that’s super helpful. Maybe just let’s talk about the, enrollment and how that’s going. I I believe the last update you gave you were getting closer to, over over halfway enrolled.

Is that right?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: Actually, a little more than that. We were halfway enrolled. I think we updated that in January in the first trial, and then we updated again about a month later that we were close to 60% enrollment. So that was in early February. Here we are now in April, and that what I can say is that the pattern of enrollment has not slowed down.

And while we haven’t yet changed our guidance to full enrollment in both trials in the second half of the year, what I can say is about the first trial Lugano is that there has been no slowdown in enrollment. We are literally setting records with enrollment. The second trial is going with the curves of enrollment look almost identical. And so the second trial is also enrolling very, very rapidly. I think this is a testament to a couple things.

First of all, we did a phase two trial and the doctors know the data from the phase two and they’re impressed with the efficacy and they’re impressed with the safety, it makes it a lot easier to talk to the patients when they can say look almost 200 patients have had this treatment already and it looks like it works and it looks like it’s safe. The second thing is everybody gets treated. We don’t withhold treatment. And so if you are randomized to the control arm, you’re getting state of the art two milligram Eylea, and obviously if you get the treatment arm and you need supplement, you’re going to get it. It’s an easy trial to understand, it’s an easy trial to explain to patients, it’s a real world trial, and it’s a two year trial.

I think that’s another advantage that we have from out the start is that the physicians know that this trial from the beginning was a two year trial and I think that they that gives them comfort about, you know, planning on keeping the patients in. So enrollment has been absolutely fantastic and again I need to call out my colleague Romero, our Chief Medical Officer. He and his team have just done a fabulous job with enrollment.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Got it, thanks Jay. And I just want to get a sense of your expectations. You know, the the primary endpoint, the 4.5 letter delta, that’s pretty well accepted. You have you have a written agreement there, so that’s not up for debate. But what do you need to see in terms of reduction in injections or percentage of patients that are supplemental injection free, at the six month, you know, interval mark to get excited about the commercial prospects, for for Dervu.

You know, we saw sixty three percent in DAVIO two, from the phase two. Is is that the right bar?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: So, let me start with, you know, the primary endpoint again, as you say, non inferior visual acuity. So at this point in the pivotal trial, that as long as we are statistically non inferior, I don’t believe the actual numerical difference matters if we are less than EYLEA. What’s the evidence of that? Well, look at high dose EYLEA. It was minus 1.4 letters worse than two milligram Eylea, but it was statistically non inferior.

But that doesn’t I’ve never heard one of my colleagues say, well, I’m not gonna use high dose Eylea because it was 1.4 letters worse. That small amount is not meaningful to doctors or patients. So the actual numerical difference, if we are less than EYLEA, is not relevant as long as we are statistically non inferior. Obviously, safety, you know, our safety track record has been great. We talked about that already.

We hope and expect to see similar safety from from the phase three. The reduction in treatment burden, there’s no number that the agency has attached to that, and so I don’t think this is a a regulatory number that needs to be hit. But, clearly, the better the reduction in treatment burden, the more effective your drug and the more likely you’re gonna be commercially successful. We were about 80% reduction in treatment burden even at one year in the phase two, and that I would expect that we will be similar or even perhaps slightly better in the in the pivotal trial. And I think we don’t need to be that good to be to be commercially successful.

You know, when we queried KOLs before the phase two data, we asked them that question, which is what type of reduction treatment burden would you wanna see for you to use this? And we then most of were around 50% was good enough. And there’s evidence of that too. If you look at the real world use of a Vobizmo, Vobizmo is doing great. It’s a, you know, $4,000,000,000 drug right now, but it only offers about a week or two longer longevity over two milligram Eylea.

Yet retina specialists are are using it, even, you know, that that small amount of, you know, longevity, a relatively small amount. So we think the majority of eyes being able to go six months or longer will open up a very large market for us.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Got it. And, Jay, we’re we’re just about at at time here, but I I do wanna, just touch on DME. You know, you you shared, the positive twenty four weeks results from the phase two Varonis study, earlier this year. What are the next steps for the DME program?

Jay Duker, President and CEO, EyePoint Pharmaceuticals: Yeah, so we’re really excited about the potential of DME. When you really look at the data, and especially you look at the rapidity which our drug worked and how it was significantly better than a single shot of Eylea as early as week four with a tremendous drying effect. And you look at the eyes that were supplement free, and they had a, you know, drying effect of almost a 25 microns and letter improvement of 10 letters, which is better than what we saw in the phase three trials for two milligram Eylea and DME. We’re really excited about the potential. So the DME, we continue to work internally on the program.

We have plans to meet with the FDA at the end of this quarter to talk about the DME program. But the first patient in the initial start of the DME trial, if you wanna call it first patient, is gonna be a 2026 event.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Got it. Thanks so much, Jay. Well, we’re over time, so I’ll end it there. Could ask you a thousand more questions, but but we’ll keep on schedule. Jay, Romero, thank you so much for joining us today.

It was a pleasure to have, EyePoint participate in our inaugural ophthalmology conference.

Jay Duker, President and CEO, EyePoint Pharmaceuticals: Thanks a lot, Lisa.

Lisa Walter, Senior Biotech Analyst, RBC Capital Markets: Bye. Take care.

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