EyePoint at Stifel Forum: Strategic Advances in Ophthalmology

On Tuesday, 27 May 2025, EyePoint Pharmaceuticals (NASDAQ:EYPT) presented at the Stifel 2025 Virtual Ophthalmology Forum, offering insights into its strategic progress. The company highlighted advancements in its DuraVu drug trials and preparations for commercialization, while also acknowledging challenges in trial enrollments and regulatory hurdles.

Key Takeaways

• EyePoint has completed enrollment for the first Phase 3 trial of DuraVu for wet AMD.
• The second trial, LUCHIA, is 60% enrolled, with completion expected in Q3 2025.
• DuraVu aims to reduce treatment frequency, with 66% of patients avoiding anti-VEGF injections for six months.
• EyePoint’s new manufacturing facility is scaling up to support a global launch.
• The company maintains a cash runway into 2027, facilitating long-term strategic initiatives.

Financial Results

• Cash Position:

- EyePoint’s financial resources are secured with a cash runway extending into 2027.

• Manufacturing:

- The new 41,000 square foot facility in Northbridge, Massachusetts, is being prepared to produce millions of doses for global distribution.

- Registration batches are underway in anticipation of NDA filing and preapproval inspections.

Operational Updates

• Clinical Trials:

- Enrollment for the first Phase 3 trial for DuraVu in wet AMD is complete, with over 400 patients in seven months.

- The LUCHIA trial is on track, with 60% enrollment completion expected in Q3.

- The end-of-phase 2 meeting with the FDA for the DME program is scheduled for early July, with updates anticipated in early fall.

• Product Development:

- DuraVu’s DuraCert e technology allows for fully bioerodible inserts with planned redosing every six months.

• Commercial Readiness:

- EyePoint’s precommercial team is engaging with payers and key opinion leaders.

- Efforts are focused on manufacturing scalability and meeting FDA inspection requirements.

Future Outlook

• Data Readouts:

- The Lugano trial’s 56-week data is expected by mid-2026, with Lucia data following soon after.

• Regulatory:

- NDA filing is in progress, with a supplemental NDA planned for two-year safety data, including redosing information.

• Label and Marketing:

- EyePoint aims for a six-month label for DuraVu, providing flexibility in redosing.

- Plans are in place for a head-to-head marketing study against leading treatments like Vobismo or high-dose Eylea.

Q&A Highlights

• DuraVu Mechanism of Action:

- DuraVu acts as a TKI blocking all VEGF isoforms and PDGF, potentially offering neuroprotective benefits and serving as a maintenance therapy.

• Phase 3 Trial Design:

- The Lugano and Lucia trials use a non-inferiority design, comparing DuraVu to aflibercept, including both naive and previously treated patients.

• FDA Guidelines and Sham Controls:

- The FDA has approved EyePoint’s sham-controlled trial design, with aflibercept as a comparator to meet regulatory standards.

• Patient Population:

- Trials include both treatment-naive and previously treated patients, with subgroup analysis planned.

EyePoint’s presentation underscored its commitment to advancing ophthalmic treatments and preparing for a robust market entry. Readers are encouraged to refer to the full transcript for a detailed account.

Full transcript - Stifel 2025 Virtual Ophthalmology Forum:

Annabel, Interviewer, Stifel: Good morning, everyone, and, thank you for joining us, for the iPoint fireside chat. We’re

Romero Ribeiro, Chief Medical Officer, EyePoint: pleased

Annabel, Interviewer, Stifel: to have George Elson, CFO of, here today and Romero Ribeiro, chief medical officer. And and you all have reached a pretty good milestone today, so congratulations on that. And I guess before we get into that, maybe you wanna give us a quick overview and lay of the land to level set everyone, and then we can launch into some q and a.

George Elson, CFO, EyePoint: Great. Yeah. Thanks, Annabel, and thanks to Stifel for inviting us to the ophthalmology conference. Yeah. We’re we’re very excited about our news, and I’m going to let, Romero talk about that in-depth as we go through the Q and A.

But we announced this morning that we’ve completed enrollment in the first of two phase three pivotal trials for DuraVu and wet AMD. We enrolled over 400 patients in seven months, great investigator in patient enthusiasm. And the second trial, which is labeled LUCHIA, is now sixty percent enrolled, and we’ve guided that that will complete enrollment sometime in q three. The nice new nice thing about that news is we’re looking now at data mid next year, for the Lugano trial. I think coming back to kind of our overview is, you know, EyePoint has been a story about execution, and this is just another example.

You know, we were talking last week that we actually dosed our first patient for DuraVu in January of twenty twenty one, and here we are in mid twenty five, completed the first of two trials. So, you know, it’s been a really great time to be here at EyePoint. I think we’re just to come back to the opening, you know, we’re we’re really focused on delivery of drug to the back of the eye. We’re excited about DuraVu, which is vorolanib, a very potent and selective TKI, that is, blocks not just all isoforms of VEGF, but also PDGF. And, we’ve shown in an animal model that it’s potentially neuroprotective.

And so we’ve been laser focused on developing that program, moving it into now phase threes, in wet AMD. Earlier this year, we reported, really positive twenty four week data in DME, and, we now have end of phase two meeting with FDA in early July, and we’ll update the street later, this probably early fall on plans for that. But DME is a 2026 event. We’ve previously discussed that this year and into next year is all about execution and getting the phase three trials enrolled. Beyond that, we continue to look not just at data next year, but, you know, getting our getting our NDA filed and working through the CMC section, we have a brand new 41,000 square foot facility in Northbridge, Massachusetts that is scaling to potentially make millions of doses to support the global launch, and that team has really been excellent in their execution.

We’re in the middle of starting registration batches to prepare for the NDA filing, but also thinking about preapproval inspection and, you know, ultimately commercial launch. So things are going really well here. We issued earnings several weeks ago. We have cash into 2027, which is well beyond our our data readout next year, and we’re excited about the future.

Annabel, Interviewer, Stifel: Fantastic. So maybe we can just talk a little bit big picture. Wet AMD and DME markets are obviously very well served by anti VEGF, even some longer duration. So, how do you envision and I know this has been tossed around many different times. How do you envision TKIs fitting into the treatment landscape?

Do you see it as a complement or do you see it as a potential replacement? And outside of duration, you trying to provide some other type of solution? So maybe you can just go big picture from that point.

George Elson, CFO, EyePoint: Yeah. Maybe I’ll answer that initially and ask Romero to comment. But point, we’ve always maintained that DuraVue is not another anti VEGF. In fact, you know, as we think about our program, and if you think about our program from the beginning, we’ve always positioned DuraVu as a maintenance therapy in wet AMD. Get your patients stable, put in our put in DuraVu.

If our phase two data holds, you know, we should be able to take two thirds or more patients six months or longer with nothing else. And that’s just on the duration story itself. We believe that DuraVu brings a new mechanism of action to this disease. If you think about wet AMD historically, it’s essentially been the same mechanism of action. It’s a ligand blocking biologic.

And we believe we bring something new. And we’re not saying use us now, not them. We’re saying use both. And if our again, based on our phase two data, there’s great evidence to support that. Ramiro, do you wanna add to that?

Romero Ribeiro, Chief Medical Officer, EyePoint: Yeah. Good morning, everybody. Thanks thanks for the question, Abel. I think the way that, retina physicians see wet AMD with the treatment of anti VEGF is that those those drugs, they work really well for those patients, but they do require a lot of frequent injections. And we see that there is a big unmet need with longer duration therapies.

I think we see this highlighted by the enrollment in our phase three study that shows that there is a big need from patients and physicians looking at duration therapies that have longer duration. The way that physicians and patients think about wet AMD today is mainly as a monotherapy. That’s just one therapy class of drug, anti VEGFs. And as George mentioned, we are bringing new methods of action. So it’s not gonna be either, anti VEGF or TKI.

It’s gonna be a combination of both, providing greater outcome for patients. We saw in our robust phase two data that patients were able to go up to six months. That was sixty six percent of patients without receiving any anti VEGF, and fifty percent of the patients with one single review went all the way to one year without any anti VEGF. We also have some preclinical data that shows that TKI inhibition with voronin from our review compound has a potential effect on fibrosis, neuroprotection. So those additional benefits we’re gonna be exploring in our phase three study.

Annabel, Interviewer, Stifel: Just mechanistically, can you talk a little bit about this anti fibrotic and neuroprotective, quality about the TKIs, that you don’t get with just straight VEGF?

George Elson, CFO, EyePoint: Romero, you wanna take that?

Romero Ribeiro, Chief Medical Officer, EyePoint: Yeah. I’ll take that one. So, one of the benefits of vorolanib is that we are blocking the receptors intracellular. So number one, we block the BGF receptors, but also we block other receptors. One of them is BGF.

So by blocking the receptors, on a constant therapeutical delivery, because we’re using the drug delivery system, there is less fluctuation of the disease. And we saw that in our phase two study where we showed that the CST had less fluctuation. So one of the hypothesis that if you have less fluctuation of the disease activity, you might end up with less fibrosis, which also has a neuroprotective effect.

George Elson, CFO, EyePoint: Yeah. And just one point to that, Annabel, is, I’m not sure all the TKIs have demonstrated that. I know in our in our case, we’ve published our neuroprotective data. I don’t believe, the competing molecule has done that yet.

Annabel, Interviewer, Stifel: Okay. I see. Is it that they haven’t shown it, or is it that that they don’t have that capability?

George Elson, CFO, EyePoint: I don’t I don’t know. Do you know that answer, Ramiro? I don’t think that they’ve done that work.

Romero Ribeiro, Chief Medical Officer, EyePoint: Yeah. I I did not know.

Annabel, Interviewer, Stifel: Okay. So maybe you can talk a little bit about physician reception to the adoption of a new mechanism and incorporating this into anti VEGF treatment. You’re effectively changing their treatment paradigm, extending the duration of response, changes their practice a little bit. So maybe you can talk about not just the reception to a completely new mechanism, something that they may not be as comfortable with, and also how it might change their practice.

George Elson, CFO, EyePoint: Yeah. So, Romero is actually a retinal specialist, so I’m gonna let him answer that question.

Romero Ribeiro, Chief Medical Officer, EyePoint: Yeah. No. Great. And I think the retina community as a whole is always looking for innovation. And if you look at the pipeline in retina, it’s very robust.

We’ve seen the new generation of anti VEGF for the past few years, being highly adopted by the physicians. And the intent of those medications are essentially to increase the treatment interval, essentially decreasing the treatment burden. And, again, those those medications were highly adopted by the retina community. I think what we are bringing, again, a new mechanism of action with the intent of providing, vision outcomes for patients while reducing the treatment burden is something that is seen as something that it needs to be addressed by the retina community and patients. And, again, I think this was highlighted in our phase three study and how rapid enrollment happened there.

George Elson, CFO, EyePoint: Yeah. I think just maybe to add to that, the the beauty of DuraVu, it’s actually administered through a syringe injector. It doesn’t disrupt practice. It’s shipped and stored at room temperature. And so as we think about the commercial execution, it fits very nicely into current practice, standards.

And the trials themselves were actually designed with that in mind as well. I think our label, if successful, will be very straightforward and easy for physicians, to read and use.

Annabel, Interviewer, Stifel: K. So maybe you can talk just really quickly review the phase two findings and talk about the safety profile to date. These are clearly implants. You’ve got different doses that might require different number of implants. Just help us understand that a little bit.

George Elson, CFO, EyePoint: Yes. Sure. Romero, you wanna review phase two?

Romero Ribeiro, Chief Medical Officer, EyePoint: Yeah. So first, to review is an insert. So it does not require any search for innovation. It’s an insert. What we’re testing in our phase three study is a 2.7.

So for the phase two program, the david two study, this was the largest wet AMD study evaluating a TKI technology to date. So in that study, patients had previously been treated with anti VEGF. They came into the study. They received three loading dose of aflibercept, and then we had three treatment arms. One was to review high dose, to review low dose, and we use aflibercept as a control.

Aflibercept was given on label every two months after the three loading dose. What the david two phase two results show is that it matched the primary endpoint at week twenty eight thirty two. That was the average BCVA. Visual outcomes were similar between the Duravu arms and the Flibercept showing a non inferiority. And what is very important is that there was a big reduction in treatment burden of about eighty percent.

When we look over time, six months after dosing with the review, sixty six percent of the patients did not require any anti VEGF. And then up to one year, that number was fifty percent. So fifty percent of patients up to one year did not require any anti VEGF. Even more important than that, in terms of safety profile, we did not see any SAE ocular systemic related to the review. So safety profile review has been, excellent, not just in wet AMD, but also in our other clinical programs.

We have those more than a 90 patients across our phase one, phase two studies, and our excellent safety profile continue those programs. I think, again, I think the safety profile review is one of the things that we hear from investigators and their excitement on the phase three study that has been a study that it was easy for them to offer to patients because they were confident on the safety profile.

Annabel, Interviewer, Stifel: Okay. There are, there have been some questions about, the insert technology and whether it accumulates that’s happened to others in the past. Can you just give us give us a little background on that?

George Elson, CFO, EyePoint: Yeah. Sure. So DuraVue utilizes what we call DuraCert e, which is stands for erodible. That’s our the kind of the the evolution of the underlying DuraCert technology, which has been kinda EyePoint’s core for a long time. And previous iterations of DuraCert, were actually non erodible implants.

It includes products like YUTIQ and ILUVIEN. And they were nonerodible because they had a polyamide shell, which controlled drug release, and that shell stayed forever. For DuraCert e, we’ve essentially removed that polyamide shell, and so the inserts that we’re now using in the phase three are 94% drug, 6% matrix, and they’re fully bioerodible. And we’ve, done animal studies to support that. Our phase three will actually be redosing every six months, and we’re we’re excited to move that program forward.

Annabel, Interviewer, Stifel: K. Yeah. Maybe you can talk about the design of the phase three, how it’s different from phase two. What are the some of the adaptations you’ve made, populations, patient populations, etcetera?

Romero Ribeiro, Chief Medical Officer, EyePoint: Romero? Yep. I’ll take that one, Annabelle. And I think going back to our phase two study, this is, you know, of course, very important that we have a very robust phase two study because that taught us a lot on how to appropriately design our phase three program. So we are following something that has been used for the past four approvals in wet AMD, which is a non priority study.

Our Lugane and Luci studies are, they are identical. They have the same study design. Patients receive three loading dose of aflibercept in the beginning, and then they get to review or the control arm. So we have one treatment arm for the review, the review two point seven milligrams, and as a control, the aflibercept. The primary endpoint is PCVA, which again is is very standard for wet AMD study, and we are assessing that at one year.

What is important in our phase three study, patients are randomized and enrolled on day one. And therefore, we’re going to see the primary endpoint one year after that.

Annabel, Interviewer, Stifel: Is there anything specific about the inclusion criteria, or even in terms of, either rescue or retreatment. I guess there’s slight differences between the different trials as far as when you rescue a patient. So can you help us understand some of the differences there? And we just wanna make sure that, people understand that, generally, the trials are similar, but there’s very there’s various tweaks that maybe they are not comparable across trials. So maybe you can help us frame that a little bit.

Romero Ribeiro, Chief Medical Officer, EyePoint: Yeah. And and this, I wanna make it very clear. Right? Lugano and Huqia are identical studies. So from an inclusion exclusion criteria, they are identical.

So we should have very similar patient population. And we are for those two studies, we are enrolling both naive patients as well as previously treated. And, again, I think we got good learnings from our phase two study on how to design those criterias. Second, in terms of supplemental criteria, again, the supplemental criteria for Lucanine Luchea are identical. There’s no difference between the two studies.

We have essentially two criteria. One is a combination of vision loss plus increase in CST, And then the second one is hemorrhage that is because of wet AMD. Those two criterias are very straightforward. They’re very, used to in wet AMD studies. And, again, I think we had a good learning from our phase two study on how to select those criterias.

George Elson, CFO, EyePoint: Yeah. And maybe if I can add to that, Annabel, we because we did a phase two, you know, we we learned a lot. And so remember, phase two was a very heavily pretreated group. That patient population came in with an average of 10 injections per year, and we did really well in that group. We had two thirds make it six months without a supplemental injection.

But actually when Romero’s team went back and looked, about twenty percent of those supplements met no criteria. And as we looked at other reasons for supplementation, it really had no effect on vision. Remember, the primary endpoint for these trials is non inferior BCVA to aflibercept. And so as we looked at the supplement criteria in the phase three, we wanted to narrow that to things that really mattered, like vision. And so, as Romero stated, the the primary the the main supplement criteria is a loss of five letters with 75 microns of new fluid.

They must supplement. There’s no negotiation. And we’ve actually taken investigator discretion away in the phase three because of a lot of the things we observed in the phase two. I think ultimately because we’ve now included these previously treated I’m sorry, these newly diagnosed patients, we should we expect that we’ll do better in the phase three because we’ll have a less needy population.

Annabel, Interviewer, Stifel: Got it. I guess one question regarding the the phase three that you just mentioned. You have both naive and previously treated patients. How might that impact the outcome if you’re having two different types of patients? Is this how it’s always been study or you you know, I I noticed you’re not sticking only with treatment naive or treatment experience.

So how should we think about how those results might evolve, and do you separate those different groups when you review the results? Are are you looking at different sub subanalyses?

George Elson, CFO, EyePoint: I’ll let Romero answer that, and then I’ll come in with, additional color. Go ahead, Romero.

Romero Ribeiro, Chief Medical Officer, EyePoint: Yeah. So, Nabil, I think what is important for both naive and previously treated is that the inclusion criteria and exclusion criteria vary are the same. So they have to have a certain amount of fluid in the retina, and they have to have also some vision loss because of wet AMD. Mhmm. So although some patients might have been treated in the past, we still believe that in terms of how they behave over time in this study is gonna be relatively similar.

Of course, we’re gonna be doing subgroup analysis splitting between naive and treatment, and previously treated. But, again, I think we’re confident because the inclusion criteria are the same that the both population are gonna behave similarly.

Annabel, Interviewer, Stifel: Okay. Got it.

George Elson, CFO, EyePoint: If I can add one thing to that. Sure. Because remember, we’re doing a non inferiority trial. So if randomization works, remember, we only have to tie. We don’t have to beat.

And we you know, again, going back to the phase two by including the naive patients, we we think that we should even do better.

Annabel, Interviewer, Stifel: Just on on that, I guess, strategy to include treatment naive patients, is that sort of a suggestion you’re trying to get in as early as possible? Are they always going to need anti VEGF as an initial treatment and then move into, TKIs? Or do you see a moment where TKIs will supplant that in some patients?

George Elson, CFO, EyePoint: Well, the trial was designed for regulatory approval. And so I think that’s the case. We we’ve never believed that you needed a load, but that was what was required for the FDA. And so we’ve gone down that path. And, actually, if you look at the DME data, we’ve, you know, we did very well, without a load.

And so, you know, the the inclusion was really to have both a wider label, but we also wanted our control arm to behave like the treatment groups did that got the non inferiority margin. So we wanted to derisk that as much as possible.

Annabel, Interviewer, Stifel: Got it. Got it. You know, maybe we can talk a little bit big picture. I know there’s a little a lot of confusion out there about FDA guidelines. Some say they like sham.

Some say they don’t like sham. Some say there’s no need for sham. They don’t like sham. Can you clarify that for us?

George Elson, CFO, EyePoint: Yeah. Happy to. In fact, you know, that that question comes up a lot, but I think it’s it’s a moot point from EyePoint’s perspective. Two things. Number one, we had an end we’ve had the type c in at end of phase two.

FDA seen our protocol and our plan and signed off on our use of sham as they have with, other competitors currently and, you know, essentially every program since Lucentis. Actually, there’s nowhere in the draft guidelines, which are draft, by the way. You don’t have to use them. That’s been said publicly by the agency. And the word sham is not mentioned there.

So there’s one corner that seems to be raising sham as an issue, but it must be their issue because, you know, we’re well aligned with the FDA on this.

Annabel, Interviewer, Stifel: Okay. Got it. And you mentioned earlier you did design retreatment into your trial. Correct?

George Elson, CFO, EyePoint: We did. Every six months. So it’s a two year the base three is a two year trial. We’ll submit with one year safety and efficacy, but we are redosing every six months over two years, and we’ll do a supplemental NDA with the two year safety, which will include four total of four doses for DuraVu. Why?

Because we want that on our label, and that’s what the agency told us. If you want redosing, you have to have that two year data with 300 patients, which is why the studies were designed the way they were.

Annabel, Interviewer, Stifel: Got it. Got it. Okay. And then, maybe just one more question with regard to guidelines. Everyone is essentially seeing aflibercept as a as a comparator.

Is it moving over to Vibizmo at some point, or is that FDA is okay

George Elson, CFO, EyePoint: with Yeah. So the FDA has been pretty clear about that. And the reason is you have to use Lucentis or aflibercept because that’s where the non inferiority margin was calculated. I I I expect perhaps over time, Vobismo will become, but, you know, where it stands now, you know, the agency is very clear. There’s just not enough data with the newer drugs.

From EyePoint’s perspective, though, you know, upon success with the phase three, assuming, you know, whether it’s high dose Eylea or Vobismo in in the lead, you know, one of the first trials we’ll do is a marketing study Mhmm. To, you know, head to head against the leader and time to first supplement. And where we have a real advantage there is, you know, we’re six months or longer.

Annabel, Interviewer, Stifel: Okay. Got it. And then, one question about just Vibizmo’s label. They have a a pretty wide label. It could be one month.

It could be up to four months, and the flexibility for has worked out very well for them in the marketplace. Is there any kind of flexibility that you’re designing into yours? What what’s your ideal label looking? No.

George Elson, CFO, EyePoint: That that’s a really And we’ve really designed this from the beginning. You know, when we talk to doctors about sustained delivery, remember DuraSuite, we’re delivering drug for about nine months, zero order kinetics. But we’re going for a six month label because when we did our early work, that’s what physicians want. And similar to you know, I know there’s an ongoing, struggle between vebisimone and high dose Eylea because of the label.

You know, where we see a real benefit in our timing is we know we’re giving drug for about nine months. Six months is the sweet spot. So say a patient presents at month seven, but you have a nine month label, you can’t redose. And so we wanted to give doctors flexibility, which is what’s been built into our design.

Annabel, Interviewer, Stifel: Okay. Got it. I know we’re running out of time, but maybe you can just talk about the timing of your catalyst and commercial readiness, in in the last minute that we’re here.

George Elson, CFO, EyePoint: Yeah. No. Thank you. So we’re you know, we continue execute here at EyePoint. So we announced Lugano today.

We’re very excited about that. Lucia, is our next milestone, which we’ve now updated to be in q three of this year. And so from a data perspective, we’ll have the Lugano Lugano fifty six week data mid next year with Lucia following shortly thereafter. So both trials will read out in 2026. From a commercial readiness perspective, we’ve been very active, in that area.

I talked about our manufacturing capabilities. We’ve been very focused on that to make sure that we cannot just provide clinical material, but also get through an FDA inspection and registration batches. And we have a precommercial team that’s already doing early work with payers and KOLs, and we will be, in a good position to not just, execute there, but also get our NDA filed, which is something that Romero’s team and our regulatory folks are already working on.

Annabel, Interviewer, Stifel: Okay. I think that’s all we have time for, unfortunately, but thank you for the the quick overview, getting into, the weeds a little bit with us, and we’re excited to see the enrollment of the next one, and then next developments.

George Elson, CFO, EyePoint: Great. Thanks very much, really, again

Annabel, Interviewer, Stifel: Appreciate it.

Romero Ribeiro, Chief Medical Officer, EyePoint: For having us. Bye.

Annabel, Interviewer, Stifel: Alright. Take care.

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