EyePoint at H.C. Wainwright: Strategic Insights on Wet AMD Trials

On Wednesday, 13 August 2025, EyePoint Pharmaceuticals (NASDAQ:EYPT) presented at the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference. The company shared strategic insights into its ongoing Phase 3 trials for Duravu, targeting wet age-related macular degeneration (AMD). CEO Dr. Jay Duker discussed trial designs, financial health, and future plans, highlighting both promising prospects and challenges.

Key Takeaways

• EyePoint is optimistic about its Phase 3 trials for Duravu, expecting non-inferiority to EYLEA and potential label expansion.
• The company has a cash runway into 2027, covering trial completion and early commercialization steps.
• Manufacturing capabilities are robust, with potential to produce up to one million inserts annually.
• EyePoint plans to enroll the first patient in its diabetic macular edema (DME) trial in 2026.
• Strategic discussions with payers and retinal specialists are underway to ensure market readiness for Duravu.

Financial Results

• Cash Runway:

- EyePoint has secured funding to extend its cash runway into 2027, a year beyond expected Phase 3 trial data readout.

- This funding supports NDA preparation, manufacturing, and initial DME trial steps.

• Manufacturing Capacity:

- The new facility can produce hundreds of thousands of inserts annually, with potential expansion to one million.

• R&D Spending:

- The cash runway includes R&D for DME but excludes commercial launch costs.

Operational Updates

• Phase 3 Trials (Lugano and Lucia):

- Enrollment is complete, with a 75%/25% split between treatment-naive and experienced patients.

- Top-line data is expected by mid-2026, with no major protocol changes anticipated.

• Manufacturing:

- The Massachusetts facility is operational, focusing on Duravu production for wet AMD and DME.

• DME Program:

- A successful FDA meeting aligned development plans, with patient enrollment set for 2026.

Future Outlook

• Wet AMD:

- EyePoint aims for Duravu to be non-inferior to EYLEA, potentially offering reduced treatment burdens.

• DME:

- The company expects faster visual and anatomical improvements compared to EYLEA.

• Regulatory and Commercialization:

- Preparations for NDA pre-approval and commercial launch are underway, with engagement from payers and specialists.

- Approval is anticipated in 2026.

Q&A Highlights

• Trial Design:

- Identical trials offer a streamlined evaluation process for the FDA.

- Including treatment-naive patients is expected to enhance results.

• Rescue Criteria:

- Simplified criteria focus on vision loss and fluid increase, based on Phase 2 learnings.

• DuraCert E Technology:

- The bioerodible technology ensures safety and efficacy with a minimal insert volume.

• Commercialization:

- Positive feedback from payers highlights the appeal of a new mechanism of action with sustained release.

EyePoint’s detailed strategic plans and operational readiness position it well for future success. For a deeper dive into the conference insights, refer to the full transcript below.

Full transcript - H.C. Wainwright 5th Annual Ophthalmology Virtual Conference:

Yi, Host, HC Wainwright: Good morning. Welcome to the HC Wainwright fifth annual ophthalmology virtual conference. For this session, we’ll have a fireside chat with doctor Jay Duker, the chief executive officer of EyePoint Pharmaceuticals. Welcome.

Jay Duker, CEO, EyePoint Pharmaceuticals: Thank you, Yi. It’s a pleasure to be here this morning.

Yi, Host, HC Wainwright: Doctor Ducker, we know that EyePoint recently reported that both phase three trials of Duravil, which are the Lugano and Lucia trials, have completed enrollment. Could you tell us whether both trials have enrolled treatment naive as well as treatment experienced patients, and will that potentially have an impact on the future data readout?

Jay Duker, CEO, EyePoint Pharmaceuticals: Well, yes. They did. In fact, both trials are essentially identical, which we believe gives us an advantage with respect to the FDA evaluating the results. And we do expect that the inclusion of treatment naive wet age related macular degeneration patients will be an advantage for several reasons. First of all, I’d like to remind the listeners that we did a very robust phase two trial of, our drug, Durvu, in wet age related macular degeneration in previously treated patients.

This was a tough to treat population in the phase two. On average, those patients had 10 injections normalized in the year leading into the trial. And in The United States, on average, patients get about six injections. So we got very few patients in that trial that had been treated and extended successfully out beyond two to three months. But we did really well to, again, to remind the audience of the results.

Both treatment arms of Duravu, two milligrams and three milligrams, were essentially identical visually to the EYLEA on label control. So the inclusion of naive patients, we believe, will give us even better results than we got in the phase two. The reason is there’s probably twenty to twenty five percent of the wet AMD population that is fairly easy to treat. They can be treated and extended out to about three month intervals with virtually any drug, And we think our drug will do very well in that population. So we think automatically by including those patients in the pivotal trials that our results and our number of supplements should go down.

Now from a safety perspective in the phase two, there were really no safety signals at all from either our drug or insert. And, of course, we’ve had no ocular or systemic SAEs secondary to our drug in any of the trials that we’ve run-in over a 190 patients. From a safety perspective, we wouldn’t expect the naive patients to act any differently, certainly. And, to remind everybody, everybody in the pivotal trials gets a monthly load of EYLEA. So by the time DuraVu gets in in in inserted at week eight, those patients aren’t technically treatment naive anymore.

They’ve already, had a load of Eyleo. We also think this will potentially lead to a broader label. We would anticipate, if approved, our label should look something like Derview is indicated in either naive or previously treated wet age related macular degeneration after three injections of an anti VEGF Mhmm. On a q six month basis. So, again, we think the inclusion of treatment naive patients, is an advantage and will derisk the program.

And just to let you know, both trials have about a seventy five percent, twenty five percent ratio naive to previously treated.

Yi, Host, HC Wainwright: Got it. Got it. So this is an ideal ratio ratio. Right? Seventy five percent versus twenty five?

Jay Duker, CEO, EyePoint Pharmaceuticals: Uh-huh. We think so. When you say ideal, we believe that that is a good mix that, allows the FDA to see how we also do in the naive population. We would expect that the previously treated patients, would probably be similar to what we saw in the phase two, relatively tough to treat. And, you know, that makes sense because if you’re a wet AMD patient and you’re already treat and extended out to three months and doing well, chances are you’re not gonna enroll in a trial that requires monthly visits.

Yi, Host, HC Wainwright: Mhmm.

Jay Duker, CEO, EyePoint Pharmaceuticals: So we’ve again, the good another good thing about doing a a phase two is we know our statistics. We know our standard deviation. We believe we found the optimal dosing of the drug, the optimal dose of the drug, and, therefore, we believe that seventy five twenty five ratio gives us the best chance for success.

Yi, Host, HC Wainwright: Got it. Thank you. Can you talk about the rescue criteria for supplemental injections in the trials? And are the current rescue rates in line with expectations?

Jay Duker, CEO, EyePoint Pharmaceuticals: So first of all, with respect to rescue or supplementation, this is a concept that, has been present really since the start of sustained release therapy. And if you’re looking at various clinical trials of sustained release therapies, you’ll note that there’s no set way to, have your rescues delivered. Each sponsor and even various trials, it can differ. So that’s an important concept. The FDA doesn’t appear to mandate a a fixed idea of how to supplement.

So our supplement criteria came out of work that we did on the phase two. Once again, a big advantage to doing a phase two. What we discovered in the phase two that there were certain supplement criteria, for example, new fluid without a change in vision that we really didn’t need to use in the phase three, and it makes sense. If your eye has stable vision that has new fluid, there’s no reason to supplement. That eye isn’t gonna see any better from a supplement.

And, ultimately, that’s the primary endpoint, visual acuity. So our supplement criteria became simple, which is a loss of five letters of vision from best on study associated with a 75 micron increase in fluid CST as measured in OCT from best on study, and they have to be together. And we believe that that will not only protect patients from visual loss, which is critical, obviously, for the patient, but off also for the result of our noninferiority trial. And it’s simple. It’s easy.

It’s easy for the physicians to remember. In addition, we had supplement criteria in the phase three that has to do with hemorrhage. We we want doctors to supplement if there’s a site threatening new hemorrhage due to wet AMD. When we evaluated the patients in the phase two trial in all three arms that were supplemented due to hemorrhage, there were nine of them in total, what we discovered was six out of the nine either didn’t have a hemorrhage or the hemorrhage wasn’t from wet AMD or it wasn’t considered site threatening. So what we’ve done is added a criteria for these sites to take a picture of the hemorrhage and adjudicate it with a rescue monitor to see if the rescue monitor agrees that this is a site threatening hemorrhage.

So it’s simple. Those are the only two, criteria that we have. And, again, in the in the phase two, we allowed physicians to rescue at their discretion, and 20% of the rescues in the phase two met no criteria at all. So that is another reason why we’re optimistic that the supplemental rate in the pivotal trials will be less than what we saw in the phase two. As for monitoring the supplemental rate, we believe that at this point, making public statements that include potential results, even masked results, may put us at risk with the agency.

Mhmm. Really don’t want to do that at this point because we feel like we are you know, to use a golf analogy, we’re hitting it straight down the fairway right now and hitting it far, and we’re we’re in line to to break, par here. And so there really doesn’t seem to be an advantage for us to, take a risky shot right now.

Yi, Host, HC Wainwright: Got it. Got it. Thank you for that. So I understand that DuraVue, utilize the bioerodible DuraCert e technology. Can you tell us how is it different from the DuraCer technology used in currently commercial product commercialized products, and could the difference have an impact on DuraBuse efficacy or safety profile?

Jay Duker, CEO, EyePoint Pharmaceuticals: Oh, sure. So, again, going back historically, the DuraSer technology has been around for several decades and is in four FDA approved products. But we when you have a drug that is very soluble, even if you admix that drug with a matrix to solidify it in sustained release it, if it’s soluble, it’s gonna go away fast. So the first medications, APIs that were put into this system were highly soluble drugs, corticosteroid and ganciclovir. And as a result result has slowed down the release.

It was necessary to put a polyamide, essentially plastic inert shell around the matrix, leaving pores to allow the drug to to diffuse out through the pores. Vorolanib is not that soluble. So for, wet AMD, we didn’t need the polyamide shell, and we didn’t want the polyamide shell. It wasn’t necessary. And because polyamide, although inert, it hasn’t caused problems, it doesn’t go away.

And if you really think about how long wet AMD patients live after their diagnosis, we didn’t see any advantage to have in these polyamide shells built up in the eye. So the bioerodible form, quite simply, is drug with matrix but no polyamide shell. So the entire insert should be fully bioerodible. Now I do wanna add, Durasertib was designed so that the matrix holds the drug together and controls the release until the drug is essentially gone. In animal studies suggest that in humans, it should be completely gone from the inserts in about nine months.

The matrix is fully bioerodible and should go away based on animal studies in several more months.

Yi, Host, HC Wainwright: Mhmm.

Jay Duker, CEO, EyePoint Pharmaceuticals: That was by design because what you don’t want is free drug particles floating inside the eye. Mhmm. At that point, you wouldn’t control the drug release anymore, and you run the risk of those free drug particles actually blocking the vision, being visible to the patient, and being visible to doctors. So we don’t have that. We shouldn’t have that.

We’ve never had that. And, again, in over a hundred ninety patients that we have complete follow-up on from the phase one and three phase two trials that we’ve run, we’ve had no patients report loss of vision due to the inserts. So overall, if you think about the the proven track record of DuraSert with the polyamide shell, we’ve actually taken away excipients. And so from a safety perspective, we think there there there really is no reason to believe that there’s a there would be a problem. We haven’t seen a problem.

And in animal trials, there there hasn’t been any safety issues even with multiple frequent reinjections. So overall, the next generation Durasert e, the next generation refers to the higher payload. We think, it will perform very, very well, and the evidence we’ve seen so far from a mass safety perspective would indicate that. I will add, one more thing about our inserts. They are now 94% drug, only 6% matrix.

And given each insert’s only about one five thousand for the vitreous cavity, when you do the math again, that little nubbin of residual matrix that might be left, after the drug is gone in nine months or sooner, really shouldn’t be any kind of problem as it as it fully bioerodes. It doesn’t break into pieces. It doesn’t emulsify. There’s no peg There’s no PLGA in it.

And so, from a safety perspective, we’re very comfortable with next generation Dirasir D.

Yi, Host, HC Wainwright: So as you said, the drug itself should go away in about nine months. The matrix could take a little bit longer to completely disappear.

Jay Duker, CEO, EyePoint Pharmaceuticals: It should. Yes.

Yi, Host, HC Wainwright: So there there shouldn’t be any safety concern associated with Durasert e for redosing at six months. Right?

Jay Duker, CEO, EyePoint Pharmaceuticals: No. And and as I said, in animals, we’ve redosed multiple times even at a shorter interval than six months and found no safety concerns. I see. Okay. From the phase one and phase two studies we ran, we’ve had up to three inserts and about 80 eyes with no problems.

No issues related to the number of inserts or inserts causing visual loss or or be a problem. So the fact that they’re 94% drug and there’s two inserts with each injection, when you kinda do the math, you end up at a steady state every six months with a volume and a mass less than three inserts. So not a not a concern.

Yi, Host, HC Wainwright: Got it. Got it. That’s very helpful. Has the data and safety monitoring committee reviewed the mask data from both trials?

Jay Duker, CEO, EyePoint Pharmaceuticals: Yes. It has. And we did report, that the, data safety monitoring committee advised no changes in the protocol from the first meeting of both trials. Now that’s important. And so our phase three was informed by our previous trials, especially the large phase two that we ran, and we’ve had no significant changes in the protocol nor do we expect any now that we’re fully enrolled.

We don’t expect any. And that’s, again, a derisking issue. Changing one’s protocol in the midst of a pivotal trial does nothing but add risk to the program.

Yi, Host, HC Wainwright: Yep. Yep. Got it. So I understand Lugano is now expected to report top one data in mid twenty twenty six and Lucia in ’26. Could you remind us the primary endpoints of the trials and your expectations for the data readout based on existing clinical evidence of the review?

Jay Duker, CEO, EyePoint Pharmaceuticals: Sure. So yes. And and, again, what I can’t emphasize enough what a great accomplishment it was for not just EyePoint in our clinical team, but the the sites and the doctors and the patients to get these two trials enrolled so rapidly. About seven months over 400 patients in each trial. It was very, very rapid enrollment, which, again, I think speaks to the enthusiasm that the doctors and patients have for our drug.

So the, again, the primary endpoint is a blended visual acuity endpoint at week 52 and week 56. So, you know, if you do the simple math, allowing for some weeks to get the data together and confirm that it’s right, we should have top line from the first trial sometime in the middle of next summer, less than a year from now. And because the second trial is identical, we would expect that if the results are positive from the first trial, they they should be positive from the second as well. From an expectation perspective, I think it’s simple. We hope and expect fully that we will be noninferior to on label EYLEA statistically and numerically.

I wouldn’t rule out that we possibly could be numerically and perhaps even statistically superior.

Yi, Host, HC Wainwright: Mhmm.

Jay Duker, CEO, EyePoint Pharmaceuticals: What’s the basis of that? Well, if you look at Davio two, the patients who were not rescued in Davio two ended up with numerically better vision than the unrescued eyes in the control group. We may be able to replicate that in the phase three. I also would point to the visual acuity results in our diabetic macular edema phase two. 10 letter improvement in the unrescued eyes, which is superior that to what you’d see from a naive population treated with EYLEA alone.

So there is some evidence that we might actually have numerical superiority to the control. Obviously, we don’t need it. Statistical noninferiority gives us our primary endpoint. We would expect safety to to match what we’ve seen in the past. We have no evidence that there would be any difference in its safety perspective.

And as I’ve said already, I think from the perspective of supplements, we would expect the supplementation rate to be to be down. And so that also leads to one of our important primary endpoints or secondary endpoint rather, which is reduction in treatment burden against the control group. And so we believe we will be able to achieve that. So that’s the expectations, and, we’re obviously very excited to be where we are today. And it’s been an incredible journey of incredible execution and dedication by our team here, and, we’re really excited for next summer.

Yi, Host, HC Wainwright: Yep. That’s very helpful. Has vorolanib vorolanib being approved in any country in the world, and what are the available approaches to facilitate the regulatory pathway in The US for therapy?

Jay Duker, CEO, EyePoint Pharmaceuticals: So, interestingly, the whole history of vorolanib goes back to the same protein chemist who developed sunitinib. And the thought was that sunitinib, which was at the time, being used, or tested orally for kidney cancer, would accomplish the same thing, but with fewer off target effects. And in the laboratory, that was true. In the company that was developing it decided instead of being the second one in for a relatively small indication, why not be the first one in for a big indication? And so they tested vorolanib orally for wet age related macular degeneration.

It went through phase one and phase two, had very good efficacy as an oral drug. But, of course, systemic TKIs and the doses used can have side effects, and it had hepatobiliary side effects, which limited its use so it didn’t get out of phase two as an oral drug. We have a partner in China, Beta Pharmaceuticals, which, has the rights to vorolanib outside of the eye. And, just recently in the past year, Beta got vorolanib orally approved in China for, kidney cancer. That is the only approval worldwide of vorolanib.

It’s it’s a new, drug entity in The United States, which gives us some advantages in the obviously, potential advantages if we’re approved, with respect to patent protection and things like that, which we think is also of of value. So vorolanib, again, well tested, known safety in the eye, and, we believe it has some, real advantages as a sustained release API.

Yi, Host, HC Wainwright: Got it. How do you expect Duravu to be used in real world practice among existing wet AMD therapies, including Lucentis and Eylea, both of which have biosimilar drugs on the market, and also abismol, sesvimo, as well as off label investing. And on that front, investing could be become an unlabeled drug for Sure. Later this month.

Jay Duker, CEO, EyePoint Pharmaceuticals: So all of the drugs that you just mentioned, all have the same mechanism of action. Mhmm. They are relatively large molecules that block the ligand extracellularly. Obviously, there’s differences, and there’s longevity differences. And I think, everybody’s well aware of how well Vobizmo has done, with the promise of one or two more weeks of extension for patients between injections.

We think that speaks very well for a drug that we think based on the phase two should, in the majority of wet AMDIs, be able to go six months or longer between injections. Now the way it’s gonna get used, again, I think we can speculate in a position to know the retina community pretty well. And and so I think that if the phase two data holds, you’re gonna see probably the same general three ways that retina specialists approach wet AMD. The the primary is treat and extend. And I think you could see a treat and extend protocol with patients who are already being treated with a ligand blocker adding DuraVu and that extending out the intervals to see how long the patient goes.

And remember, in that situation, if I’ve got a patient where I have to treat every four weeks with Eylea and I add a DuraVu and I don’t see fluid again for four months So even though it’s not six months, I can then give the patient another Eylea, and then at six months, give them another DuraVu. And all of a sudden, you’re talking about two to three shots a year instead of twelve shots a year. So that’s a win. That’s a win for everybody. Mhmm.

Plus, the doctor’s gonna be able to take advantage of two MOAs. We’re used to chronic disease all over the body, including the eye, approaching chronic disease with more than one MOA. We don’t do that right now for wet AMD or die diabetic macular edema, and we think our drug gives the opportunity to add a second MOA also with what I like to call an insurance policy. You know, if you’ve got an elderly patient who you’ve tried to treat and extend out three to four months, that’s a long time to go between visits. And if they get sick or they go on vacation or they miss a visit, it’s hard for doctors to get them back in.

I think doctors will like the peace of mind of having a sustained release insert in the eye, knowing that they’re still getting drug even if they miss a visit. The other advantages that we have, which probably will lead to even more uptake, is we potentially will be anti fibrotic. And we’ve as you may know, we’ve had some preclinical data to suggest that we’re neuroprotective. And if we can show either or both of those in the pivotal trial, I think that would make it a situation where doctors would use us without hesitation if we’re approved. So I think that the integration of a second MOA that sustained release is something that doctors are really looking forward to now.

And I, believe that, given positive data, our uptake will be rapid.

Yi, Host, HC Wainwright: Can you talk about, your expectation on how receptive the payers will be for a six months TKI treatment for?

Jay Duker, CEO, EyePoint Pharmaceuticals: Well, given that we’ve done a lot of work already on that, we’ve had a a an early product development group working for two years to, work with retina specialists, not just the KOLs, but the retina community in general, working with payers and working with administrators of various retina groups, both private equity, non private equity, large and small, to to really find out what it is they want and how can we best position DuraVu to give them what they want. The payers have been very receptive. They just have. That the idea of a a new MOA with sustained release and the ability to take at least some patients out longer between injections because remember, the burden isn’t the cost of the drug. The burden’s the visit.

The burden’s the OCT. The burden’s the cost of injection. So there’s other peripheral charges around, visits that payers would like to see more efficiency if possible, and we hope to provide that.

Yi, Host, HC Wainwright: Got it. What is your current manufacturing capacity for DuralView?

Jay Duker, CEO, EyePoint Pharmaceuticals: So current at the moment, we, manufacture and are capable of manufacturing thousands of inserts here in Watertown in in our in our in our main office. As we’ve announced and and made people aware that we built a manufacturing facility that is about a forty five minute drive west of here in Northbridge, Massachusetts. This is a 41,000 square foot facility built to our specifications controlled by us that is, at the present time, only gonna be manufacturing to review for wet AMD and DME. That is, facility is up and running. We’re currently doing registration batches there.

And at the current capacity, potential capacity with the eight clean rooms, we would estimate that, we can make hundreds of thousands, of inserts there a year, which, should be adequate not only for The United States, but should we choose to launch out of The United States there as well. Now we also have capacity in that site, to expand, not just within the current footprint and add to it. And so in the future, we have the potential to make about a million inserts a year there. Obviously, that’s not where we made the inserts that we’re currently using in study, and we don’t believe we’re gonna have to do any kind of human bridging study between it. And we are actively preparing for, NDA preapproval inspection and eventual commercial success.

Yi, Host, HC Wainwright: Got it. Thank you. Switching to the, indication of diabetic macular edema. Can you talk about your plan for this indication and whether you expect the review to, show comparable performance in these patients?

Jay Duker, CEO, EyePoint Pharmaceuticals: So, from the plan’s perspective, we had an interface two meeting with the FDA in, middle of the summer. We’ve had some back and forth exchanges with them, and expect to see the final written minutes shortly. And, once we’ve fully evaluated that, we’re gonna talk publicly about what our plans are. The meeting went very well, and, we’ve really reached alignment on virtually everything that we wanted to with respect to, the plans. And, as we’ve said already, though, the first patient in in DME is a 2026 event.

And so while we’re doing some of the early work now to get ready to for manufacturing and hiring some new clinical positions, etcetera. First patient in is will be will be next year. With respect to how we we’re gonna do, I I am really excited about our phase two VORONAS study. The first thing to look at, if you look at the results here, is our higher dose arm, two point seven milligrams, which is what we’re using in the wet AMD trials and what we expect to go to market with, did incredibly well, and it did it fast. If you look at the four week visual acuity results against EYLEA in this population where everybody was active with DME, everybody was wet, within four weeks, we were already much better than EYLEA, both anatomically and visually.

And in the eyes that were not rescued, it was over 10 letters improvement with about a 120 microns improvement of fluid, much better than what EYLEA showed in this trial. So we think there were odds of us being noninferior is very high, and we also think that, we may be able to achieve this type of visual acuity improvement and anatomic improvement faster than EYLEA, which would be a huge advantage in the marketplace.

Yi, Host, HC Wainwright: Got it. Does the company currently have enough cash to complete the pivotal trials in with MD, obtain regulatory approval, and commercially launch?

Jay Duker, CEO, EyePoint Pharmaceuticals: The first part, yes. We have a cash runway that is into 2027 about approximately a year beyond data. So cash runway for that is good. We have talked about, all the current NDA prep that we’re doing, the manufacturing prep that we’re doing, getting prepared for the DME trial. That’s all within that cash.

The DME trial is not on obviously, commercialization, is not in that either. But I’m gonna state the obvious. We’re we’re optimistic that if we achieve the type of results we fully expect to achieve from the phase three trial, the value creation that will come to our investors, in the position that we will be in, I don’t think we’ll have any problem through multiple avenues to raising enough cash to be able to successfully launch the drug in The United States ourselves.

Yi, Host, HC Wainwright: Yep. Got it. Doctor Ducker, we are getting to the end of the chat. Do you have any closing remarks to the audience?

Jay Duker, CEO, EyePoint Pharmaceuticals: Well, I again wanna thank you, Yi, for having me on and just say how excited we are here at EyePoint to be in the position that we’re in. The first patient was dosed with our drug only four and a half years ago, and here we are after a robust phase two wet AMD trial, having fully enrolled very rapidly two phase three trials and, expecting the results in less than a year. We’re in a really good position.

Yi, Host, HC Wainwright: Thank you very much. Best wishes.

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