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Date

Wednesday, May 6, 2026 at 8:30 a.m. ET

Call participants

  • President and Chief Executive Officer — Jay Duker, M.D.
  • Chief Financial Officer — George Elston
  • Chief Medical Officer — Ramiro Ribeiro, M.D.
  • Chief Commercial Officer — Michael Campbell

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Takeaways

  • Cash and Investments -- $223 million at quarter-end, projected to fund operations into the fourth quarter of 2027 beyond key Phase III milestones.
  • Total Net Revenue -- $0.7 million, reflecting a substantial decrease from $24.5 million in the comparable prior-year quarter, due to recognition of deferred revenue from a prior YUTIQ license agreement.
  • Operating Expenses -- $88 million versus $73 million in the prior-year period, primarily driven by ongoing Phase III DURAVYU trials and manufacturing scale-up.
  • Net Loss -- $85 million, or $0.99 per share, compared to $45 million, or $0.65 per share, in the comparable prior-year quarter.
  • Clinical Progress — Wet AMD Program (DURAVYU) -- All patients in both Phase III trials (LUGANO and LUCIA) have completed the week-32 visit and have received a second dose; more than 35% have received a third dose at week 56.
  • Trial Discontinuation Rate -- Approximately 5% for DURAVYU in ongoing Phase III studies, below the typical 10% yearly average in wet AMD trials; no discontinuations were treatment-related.
  • Data Safety Monitoring -- Two positive Data Safety Monitoring Committee recommendations received, with a third review scheduled for later in May; no new safety signals identified to date in ongoing trials.
  • Phase III DME Program (DURAVYU) -- COMO and CAPRI trials have enrolled over one-third of planned patients since first dosing at February end; company targets full enrollment in both by the third quarter of 2026.
  • Manufacturing Capabilities -- Northbridge, Massachusetts cGMP facility operational for over a year and supporting CMC requirements for anticipated regulatory filings and commercial supply.
  • Peer-Reviewed Data -- ARVO presentation reinforced vorolanib’s multi-mechanism of action, including JAK1-mediated IL-6 inhibition, based on kinase screening and in vitro studies.

Summary

EyePoint Pharmaceuticals (EYPT +0.23%) confirmed pivotal Phase III wet AMD trial top-line data (LUGANO) will be reported this summer, with LUCIA results to follow. Management stated both trials use derisked non-inferiority designs versus on-label 2-milligram aflibercept controls and target 6-month redosing, supporting real-world relevance. The DME program’s COMO and CAPRI trials are enrolling rapidly, leveraging the existing investigator network; over one-third of patients are enrolled with full enrollment targeted this year. Financial discipline was emphasized, with the cash position funding key value-creation milestones. Commercial readiness activities advance, including the appointment of Michael Campbell as Chief Commercial Officer and cGMP scale-up for anticipated launch preparation.

  • Chief Executive Officer Jay Duker said, “We remain on track to deliver these Phase III top line data in wet age-related macular degeneration or wet AMD, beginning mid-year, positioning us to potentially be the first to market among all current investigational sustained release programs.”
  • “a single dose of DURAVYU demonstrated durable efficacy with improved vision and tight anatomic control.” in Phase II, per company statement.
  • Data Safety Monitoring Committee has issued two consecutive positive recommendations for Phase III trials, and all trial discontinuations so far were not treatment-related.
  • Vorolanib—DURAVYU’s active component—was described as a “potent inhibitor of JAK1,” with preclinical and in vitro data supporting multi-mechanism action against VEGF, PDGF, and IL-6-driven pathology.
  • All 90 wet AMD investigators invited to participate in the DME trial also accepted, indicating broad clinical enthusiasm, as noted by the management team.
  • Operating expenses rose $15 million year over year due to advanced clinical trial activity and manufacturing investments.

Industry glossary

  • DURAVYU: EyePoint’s lead investigational therapy, a twice-yearly, bioerodible, intravitreal implant containing tyrosine kinase inhibitor vorolanib for major retinal diseases.
  • LUGANO / LUCIA: Phase III pivotal trials for DURAVYU in wet age-related macular degeneration.
  • COMO / CAPRI: Phase III pivotal trials for DURAVYU in diabetic macular edema.
  • CMC: Chemistry, Manufacturing, and Controls; regulatory area concerning drug formulation and production processes.
  • cGMP: Current Good Manufacturing Practice regulatory standard for pharmaceutical production facilities.
  • IL-6: Interleukin-6, an inflammatory cytokine implicated in retinal disease pathology.
  • JAK1: Janus kinase 1, a key enzyme in inflammation signaling targeted by vorolanib.

Full Conference Call Transcript

Jay will begin with a review of recent corporate updates and discuss our ongoing clinical programs for DURAVYU in wet AMD and DME. I will close with commentary on the first quarter 2026 financial results. We will then open the call for your questions, where we will be joined by Dr. Ramiro Ribeiro, our Chief Medical Officer; and Mike Campbell, our Chief Commercial Officer. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found in the Investor Relations tab on the company website, www.yepoint.bio.

Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory matters and time lines, the potential success of our products and product candidates, financial projections and our plans and prospects.

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is on file with the SEC and in other filings that we have made or may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of EyePoint.

Jay Duker: Thank you, George. Good morning, everyone, and thank you for joining us. The start of 2026 for EyePoint was marked by a strong quarter of consistent execution as we approach a pivotal inflection point for our lead program, DURAVYU. We have strong conviction that the upcoming LUGANO and LUCIA readouts will catalyze our future transition into a fully integrated biopharmaceutical company, furthering our mission of improving the lives of patients with serious retinal disease. We remain on track to deliver these Phase III top line data in wet age-related macular degeneration or wet AMD, beginning mid-year, positioning us to potentially be the first to market among all current investigational sustained release programs.

In Diabetic Macular Edema, or DME, we are seeing strong momentum in our Phase III program with enrollment rapidly progressing to support our ambitious goal of full enrollment in both pivotal trials in the third quarter of 2026. As we advance towards these significant milestones, we are confident that our clinically-rigorous, derisked and patient-centric approach will continue to reinforce DURAVYU's best-in-class potential in the 2 largest retinal disease markets. The fundamental strength of the DURAVYU program lies in its robust and differentiated clinical data. In Phase II trials, a single dose of DURAVYU demonstrated durable efficacy with improved vision and tight anatomic control.

In over 190 patients across 4 completed clinical trials, DURAVYU has demonstrated a consistently favorable safety profile with no safety signals. That profile continues to hold in our ongoing Phase III LUGANO and LUCIA trials for wet AMD as observed on a mass basis, where our low discontinuation rate of about 5% remains well below the 10% yearly average typical for wet AMD trials. Importantly, none of these discontinuations were related to treatment. At this stage, all patients across the LUGANO and LUCIA trials have reached the week-32 visit, during which patients in the DURAVYU arms received their second DURAVU dose. Over 35% of those patients have since received their third planned dose of DURAVU at week 56.

As a reminder, we received 2 consecutive positive recommendations from the independent Data Safety Monitoring Committee with a third review scheduled for later this month. We are optimistic that the interim masked safety data will continue to remain consistent, further strengthening DURAVYU's clinical profile. In addition, we believe the multi-mechanism of action or MOA of DURAVYU's active ingredient, vorolanib, will prove to be a key clinical differentiator. Along with blocking all VEGF isoforms and PDGF at the receptor level, preclinical data supports vorolanib's ability to inhibit IL-6 signaling via the JAK1 receptor.

With this unique ability to not only address both the vascular leakage and inflammation that contributes to retinal disease pathogenesis, but also potentially provide sustained release efficacy, DURAVYU is uniquely designed to deliver wide-reaching therapeutic potential. Earlier this week, we presented peer-reviewed data at the Association for Research in Vision and Ophthalmology, or ARVO meeting that reinforces these findings and further substantiate DURAVYU's potential to improve long-term outcomes for patients. A primary kinase screen and subsequent measure of IC50 levels identified vorolanib as a potent inhibitor of JAK1, which plays a critical role in IL-6 mediated inflammation. In addition, vorolanib proved to be a potent inhibitor of IL-6 leakage in an in vitro cellular model.

This data further highlights the multi-MOA potential of DURAVYU with the opportunity to bring a synergistic anti-inflammatory effect in addition to established VEGF and PDGF inhibition to the treatment of wet AMD and DME. As we near top line data for our Phase III wet AMD program, it's worth remembering the key elements underpinning its thoughtful design. Our approach is derisked, following an established non-inferiority regulatory pathway. Both pivotal trials are identical and compared DURAVYU to on-label 2-milligram aflibercept, which is intended to reflect real-world practice and generate clinically-relevant data to inform the retina community.

Additionally, both trials are evaluating 6-month redosing and statistical superiority in treatment burden reduction to support the potential for a compelling label that addresses the need for effective, durable disease control. Taken together, we believe our Phase III program is well positioned to deliver data that will build upon our positive clinical development track record and contribute to strong commercial positioning for DURAVYU, if approved. We look forward to reporting top line data from our Phase III wet AMD trial, LUGANO, this summer with our second trial, LUCIA to follow shortly thereafter. We are applying the same derisked approach to our Phase III DME program, which leverages a non-inferiority design, an on-label 2-milligram aflibercept control, and redosing every 6 months.

Similar to our wet AMD program, we designed our pivotal trials for DME based on impressive data from the Phase II VERONA study in which DURAVYU demonstrated rapid efficacy with 4 to 5 letters of vision improvement and approximately 50-micron improvement in anatomic control compared to aflibercept at week 4. Both of our DME trials, COMO and CAPRI are now underway with over 1/3 of patients enrolled across both trials following first patient dosing at the end of February of this year. Our strong pace of enrollment is driven by our ability to leverage our pre-existing clinical trial infrastructure and investigator network as well as the significantly smaller trial size compared to our wet AMD program.

We expect top line data in the second half of 2027. Stepping back, both wet AMD and DME together represent the vast majority of the global branded retinal disease treatment market with a combined branded opportunity totaling nearly $15 billion in the U.S. and growing. Through exceptional clinical leadership and commitment to serving the retinal community, we are positioning DURAVYU to become a durable franchise with blockbuster potential. With a unique multi-MOA, robust clinical data package, proven delivery technology, the ability to be shipped and stored at ambient temperatures and administration via standard in-office intravitreal injection, DURAVYU represents a compelling and truly innovative product profile that has the potential to reshape the treatment paradigm for serious retinal diseases.

We continue to make significant strides in our commercial readiness while remaining disciplined in our investments as we prepare for regulatory submission. We have thoughtfully grown our organization with the addition of Michael Campbell as Chief Commercial Officer last quarter. In addition to expansion across key areas such as marketing and market access, regulatory, compliance and medical affairs to build on our organizational capabilities as we advance our launch planning and strategy for DURAVYU in wet AMD. In addition to progress on our commercial readiness activities, we continue to prioritize CMC readiness.

Our cGMP facility in Northbridge, Massachusetts has been online for over a year, supporting our plans for an anticipated CMC submission for our potential new drug application or NDA as well as for commercial supply, if approved. We continue to prepare for pre-approval inspection, underscoring our growing independent commercial readiness that we believe will ensure our preparedness to deliver DURAVYU to patients upon potential approval. Before passing it over to George to review the financials, I'd like to thank the entire EyePoint team for your unwavering commitment to improving the quality of retinal care. We are proud to support the retina community and grateful to the patients, study coordinators and clinical investigators who enable our research.

We look forward to our upcoming Phase III wet AMD readouts together with continued progress in our DME program, which we believe sets the stage for meaningful value creation at EyePoint. I will now turn the call over to George.

George Elston: Thank you, Jay. As the financial results for the 3 months ended March 31, 2026, were included in the press release issued this morning, my comments today will be focused on a high-level review for the quarter. Importantly, we continued our disciplined financial management and good stewardship of our resources, ending the first quarter with $223 million in cash and investments. For the quarter ended March 31, 2026, total net revenue was $0.7 million compared to $24.5 million for the quarter ended March 31, 2025. The decrease was primarily driven by the recognition of remaining deferred revenue related to the company's agreement in the second quarter of 2023 for the license of YUTIQ product rights.

Operating expenses for the quarter ended March 31, 2026, totaled $88 million compared to $73 million in the prior year period. This increase was primarily driven by the ongoing Phase III trials for DURAVYU in both wet AMD and DME and the scaleup of our Northbridge commercial manufacturing facility. Net non-operating income totaled $2 million and net loss was $85 million or $0.99 per share compared to a net loss of $45 million or $0.65 per share for the prior year period. As I noted earlier, cash, cash equivalents and investments in marketable securities on March 31, 2026, totaled $223 million compared to $306 million as of December 31, 2025.

We continue to expect that our current cash position will enable us to fund operations into the fourth quarter of 2027 beyond key milestones for the Phase III wet AMD program expected later this year. In conclusion, we're pleased with EyePoint's progress so far in 2026 and remain well capitalized to deliver DURAVYU through key value-driving milestones in the 2 largest retinal disease markets. I will now turn the call back over to Jay for closing remarks.

Jay Duker: Thank you, George. As we continue to deliver on our key priorities for 2026, our team is focused on advancing preparations for the pivotal Phase III top line data readout in wet AMD expected mid-year and completing enrollment of our Phase III DME program in the third quarter of this year. We believe TKIs represent the next frontier in retinal disease innovation, and we are proud to be advancing DURAVYU as a potential first and best-in-class option in the 2 largest retinal disease markets. Thank you all for your attention this morning. I will now turn the call back over to the operator for questions.

Operator: [Operator Instructions] Our first question comes from the line of Tess Romero with JPMorgan.

Tessa Romero: So just one from us, on the DME side, actually. So for your COMO and CAPRI trials, you talked a bit about your swift pace of enrollment here. Can you speak to what you're hearing from the investigators in terms of the level of interest from both patients and physicians around a TKI sustained delivery treatment option like DURAVYU? What are the key differences and similarities that you hear in the DME space versus maybe what you heard in the wet AMD space?

Jay Duker: Thanks for the question, Tess. Given that our CMO, Ramiro Ribeiro, is really at the forefront of this, I'll ask him to answer your question.

Ramiro Ribeiro: Tess, thanks for the question. So first, as you mentioned, we are seeing a great excitement around our DME program, COMO and CAPRI with a quite quick enrollment so far. We are now leveraging all the infrastructure that we use for our wet AMD with our clinical sites and our CRO and vendor as well. The feedback that we're getting from the investigators, very similar to our wet AMD, is that our study is a very patient-centric study, trying to address a very important unmet need, which is the treatment burden. So patients that are participating in this study are very excited for a therapy that can last for about 6 months.

In particular, for the DME indication, we know that the need for this patient population might be even greater than wet AMD. This is a patient population that is relatively younger, and they are still in the workplace. So a therapy that can reduce the number of visits like DURAVYU is, of course, of very interest for this patient population. Again, I think the excitement both from the investigators, the patient in clinical sites is being reflected in the pace of our enrollment.

Jay Duker: And I'd like to add just one more thought to this. We invited 90 of our wet AMD investigators to be investigators in the DME trials and all 90 accepted. So we believe that continues to show investigators' enthusiasm for the potential of DURAVYU.

Operator: Our next question comes from the line of Yigal Nochomovitz with Citigroup.

Yigal Nochomovitz: I'm just wondering if you could comment on how the supplement trigger criteria are functioning in the Phase III trial relative to the Phase II trial, the DAVIO 2 trial? And if you could also comment on what you would expect to be a meaningful supplement rate in the Phase III trial that would be consistent with a strong commercial uptake.

Jay Duker: Yigal, nice to hear from you. Thanks for the question. With respect to supplements, I'm going to have Ramiro comment in a moment about how that is working in the trial. But I think there's really 2 issues around the supplementation that people should understand. The first is that in the clinical trials, supplements will be handled statistically with sensitivity analyses that we will be doing when we submit the NDA. So there is a rate of supplements, at least conceivably, above which the drug would not be considered to be working independently because of the high rate of supplements.

In saying that, the FDA has never put a line in the sand as to what that level would be, because they want to see the totality of the data. They want to see the safety and the efficacy otherwise. So, from a supplementation perspective, there is an important hurdle, which, of course, we need to get over, which is the non-inferior margin, which is the primary endpoint. If we are approved, then I think the commercial acceptance shifts to a very different place. In the real world, a supplement is not a failure.

Doctors, I believe, if we are approved, will enjoy taking advantage of using 2 MOAs to help a [indiscernible] across a lot of chronic diseases, where if 2 MOAs in treatment are available, using them synergistically is a potential advantage to patients. Now obviously, we haven't shown that yet in our trials, but we hope that, that would be the case for the benefit of patients. But my point about supplements in the real world, I'll give you again an example. If I've got a patient that I have to inject every 2 months with a biologic anti-VEGF and let's hypothesize that DURAVYU is FDA approved, it's safe, it's tolerable.

It has a label for every 6 months and the patient gets shifted to DURAVYU, for the next year with 2 injections. But in addition, they received 2 injections of a biologic. Well, it's a great win for everyone. The patient can go from every 2 months to every 3 months from 6 injections to 4 injections and that presumably the advantages of DURAVYU will be aligned with the patient and the doctor's interest. So there is the regulatory hurdle that needs to be reached over supplements. And if that's reached, I believe that supplementation in the real world will have great latitude for acceptance.

Yigal Nochomovitz: Okay. And then if I could just ask one other follow-up on DME. Of course, you mentioned IL-6 as a potentially interesting biomarker. Are any of those IL-6 biomarker endpoints formally embedded in the Phase III DME program as sort of secondary endpoints that could help differentiate the product?

Jay Duker: I would say yes, but indirectly. Given that there is no way to measure in a patient in a clinical trial, the direct effects on IL-6 or JAK1, we would be measuring the indirect effects. The indirect effects, of course, number one is visual acuity. What we hope to be doing in the long term is provide better visual acuity for patients. But in DME, we may be able to provide it in the short term. Again, looking at the VERONA data at week 4, the patients who received DURAVYU had better vision and drier retinas as early as week 4 compared to a single dose of aflibercept.

We have set up the COMO and CAPRI trials to try to show that. And there is a secondary endpoint of visual acuity and OCT at week 4, given our drug is given at day 1 in the DME trials so that -- we hope to show that even if we're non-inferior and equivalent to Eylea, but we can provide the benefit earlier with fewer injections, then we will be able to have a great advantage to patients and therefore, a commercial success. There are other secondary endpoints that we can look at that are not direct measurements of IL-6 or JAK inhibition. For example, leakage on fluorescein angiography.

And you may recall that in the VERONA trial, we had a significant reduction in leakage as measured by an independent reading center, and it was dose-dependent, with the higher dose of 2.7 milligrams showing much greater leakage reduction compared to the lower dose and compared to the aflibercept control. And that is the kind of secondary endpoint that if we can show reduction in leakage greater than aflibercept, I think the evidence would lead to that is due to IL-6 inhibition.

Operator: Our next question comes from the line of Faisal Khurshid with Jefferies.

Faisal Khurshid: I just wanted to ask on the ongoing wet AMD studies, are you guys able to see blinded rescue rates? And are those tracking in line with your expectations?

Jay Duker: Thanks for the question, Faisal. Again, I'll let Ramiro talk about the supplementations and what we're seeing and what we're not seeing.

Ramiro Ribeiro: Faisal, thanks for the question. We -- there's a very small team at EyePoint that reviews the supplementation injections essentially to make sure that the clinical sites are following the protocol. But we don't review aggregated supplemental injection rate, and that's something that we don't disclose publicly.

Jay Duker: And if I may add, we -- again, as Ramiro indicated, have no insight into the number of supplements, supplementation rate, et cetera, at this point. It's all masked. But we do anticipate that the supplementation rates in the Phase III trials will be less than what we saw in the Phase II for several reasons, again, due to the tightening of the supplement criteria, getting rid of the physician discretion in supplements, the reinjection at month 6 and the inclusion of the majority of naive patients, all of those together should result in fewer supplements in Phase III.

Operator: Our next question comes from the line of Yatin Suneja with Guggenheim.

Eddie Hickman: I'm sorry. This is Eddie on for Yatin. Thinking about the fixed-dose regimen that you guys are going after, are patients who are already dry with stable vision still receiving that third dose at week 56? And if so, is there any incremental safety signal from redosing well-controlled patients? And further, has the FDA weighed in on how this complicates the retreatment redosing schedule?

Jay Duker: Thanks, Eddie. Very good question. And yes, this is a fixed dose regimen. It has nothing to do with whether the patient at the time of their repeat dose of DURAVYU is dry or wet or what the visual acuities are. So just like any drug, for example, take 2-milligram Eylea, when it was first studied every 2 months, that was fixed dose where they received that injection, whether they were active or not. So that's going to be true in our trial. From the perspective of safety, we've done extensive preclinical safety in animals.

And in rabbits, we never found a maximally tolerated dose of vorolanib, and we've injected scale dose of about 10x higher than anything we could achieve in humans. We've also not found the maximally tolerated number of inserts in rabbits. And so from a safety perspective, we were not concerned about reinjection. Again, we are reviewing the masked safety. And I will once again turn to Ramiro if he wants to comment on the upcoming DMC meeting that is going to be occurring shortly.

Ramiro Ribeiro: Yes. No, thanks, and thanks, Eddie, for the question. We -- as Jay mentioned, safety is something that is, of course, paramount for EyePoint, and we conduct ongoing safety review of the data. If you do the math, we have now have patients that reached that week 56 visit that you mentioned, which is the third dose of EYP-1901, and we haven't seen anything different than what we saw before. We do have an upcoming DMC meeting in the month of May, where the members will review our masked data, and we look forward to provide updates after that meeting.

Operator: Our next question comes from the line of Debanjana Chatterjee with Jones.

Debanjana Chatterjee: So what have you seen in the masked safety data set so far? And has anything shifted your expectations going into the DSMB review that is scheduled for late May?

Jay Duker: Thanks for the question, Debanjana. And we're not commenting on any individual SAEs or AEs. But in total, I would say and repeat what Ramiro has said, what we've seen so far is consistent with what we have seen in the prior 4 trials. No new safety concerns and no incidents that we haven't seen or expected from before. Again, Ramiro, I don't know if you want to add any more color to what I said.

Ramiro Ribeiro: Yes. No, I think just again, to reiterate, safety at EyePoint is paramount. We -- internally, we review the data on an ongoing basis on a masked fashion. And as Jay mentioned, we have no safety signal. We haven't attacked anything that is new. The safety profile continues to be very similar to what we saw in our previous completed studies.

Debanjana Chatterjee: Just a very quick follow-up. Can we expect any formal public update following the DSMB meeting?

Jay Duker: Yes. I think it's likely that we will give an update, yes.

Operator: Our next question comes from the line of Lisa Walter with RBC Capital Markets.

Lisa Walter: Congrats on the progress. We have seen a long-acting TKI competitor had a successful readout of their pivotal study earlier this year. And we've heard their plan is to file with the FDA and seek approval on this trial alone. In a scenario where essentially both, yours and the other long-acting TKI, are being launched within similar time frames, does perhaps having 2 products with the same mechanism of action actually help break into a market which already has an established therapeutic base with the anti-VEGF? How should we think about this?

Jay Duker: Yes, Lisa, thanks for the question. It's a great question. And I think you've really hit on a very important point. This is not a zero-sum game. The TKIs are going into a multibillion-dollar market. And there is certainly room for 2 competitors to both be very successful in this very large market. There is evidence from -- as I think you're alluding to, from other launches with new mechanism of action into an established space that having more than one entry really helps both because doctors are hearing it and learning about it from multiple places. So we welcome another competitor. And part of that is we believe we've got a better drug and a better delivery system.

And hopefully, if both are FDA approved, well we will have the opportunity from a commercial basis to really show that.

Operator: Our next question comes from the line of Nick for Colleen Kusy with Baird.

Nick Quartapella: It's Nick on for Colleen. So just at ARVO and other recent scientific conferences, just wanted to ask what -- just what the takeaways were on DURAVYU, sentiment among physicians and if you got any learnings about how physicians intend on using DURAVYU upon a potential approval?

Jay Duker: So one point I'd like to make, and thanks for the question, Nick. One point I'd like to make about ARVO is we had a poster there, which showed another preclinical model of leakage induced by VEGF and IL-6. And in that model, vorolanib, the active ingredient in EYP-1901 was able to suppress the inflammation induced by IL-6 and VEGF equal to an anti-VEGF and an anti-IL-6. So again, one more model that suggests that vorolanib does have potent anti-IL-6 activity through the JAK1 receptor. There was a lot of interest in that poster. A lot of KOLs saw it, and there were quite a number of comments.

Ramiro met with multiple KOLs at ARVO, and I will let him weigh in on what the sentiment seems to be around EYP-1901.

Ramiro Ribeiro: Yes. No, thanks, Nick, for the question. And we had a very productive ARVO this year with several posters being presented, including the one that Jay just mentioned. We also had a few advisory boards and some interactions with our Phase III wet AMD and DME investigators. I think first on the sentiment of the clinical trials, I think everybody, of course, is very excited for the upcoming data for LUGANO and LUCIA. Mentions are, this is going to be the highlight of the retina space for the year of 2026. For DME, the investigators, again, reflect that this is a really well-studied plan, very patient-centric, and they were all excited about bringing the therapy for patients with DME.

In terms of future use of DURAVYU, as Jay mentioned previously in the call, they expressed the important unmet need that we're trying to address with DURAVYU. And they see this if we can replicate the results that we saw in the Phase II study as something that is going to be very meaningful for patients, especially for those patients that require frequent treatment.

Operator: Our next question will be coming from the line of Yale Jen with Laidlaw.

Yale Jen: And I just follow up a little bit on the commercial question earlier, which is that besides the TKIs, in terms of the long-acting biologics, VABYSMO and the high-dose Eylea, which one you think you [ scale really ], if approved, will be competing more or less? And any comment on that?

Jay Duker: Thanks for the question, Yale. It's an important question because these are excellent medications that are multibillion-dollar drugs that are really helping many, many patients. I think the first point to be clear on is we're not another anti-VEGF biologic. We work at the receptor level. We have multi-MOA block VEGF, PDGF, and we do believe the inflammation related to IL-6 elevation, which is not something that they do. In addition, it looks like from our Phase II data that at least 2/3 of the wet AMD population could be treated with our drug alone every 6 months should physicians choose to do that. That's not something that we're seeing in the real world with those new medications.

While there are extended durations, what the real-world data is suggesting that most patients are getting about a week or 2 extension from either of those drugs compared to what they were on before. Now that's great, but we still believe that it leaves a lot of room in the market for a 6-month or longer medication. I -- it's hard to predict which of those drugs will be -- I don't want to say the winner because I think both drugs are doing well when we launch potentially. But we -- again, our belief is that we can provide benefits greater than what either of those drugs can do for patients.

And we believe in the long term, we will achieve better visual acuity. Mike Campbell, our Chief Commercial Officer, I believe, is on the line. And I don't know if he's going to maybe have any other comments now. I think it's a little early to talk about commercial strategy. But maybe, Mike, you can talk a little bit about how you view the competition.

Michael Campbell: Yes. Thank you for the question. The one point I would add is that while we have these very good anti-VEGFs, longer-acting anti-VEGFs in the market, not only is the real-world data showing the extension that Jay mentioned around 8 days. We also look at what the retina specialists are saying in the community and where the needs are. And so if you look at the American Society of Retina Specialists, ASRS, every year, they put out a PAT survey. And very consistently, the #1 need in wet AMD treatments that is reported from ASRS is still durability even with VABYSMO and Eylea HD in the market.

So to Jay's point, there is a very clear opportunity should DURAVYU be successful and be approved, there's a very clear opportunity or room in this market for more durable agents.

Operator: Our next question comes from the line of Samuel Rollenhagen with TD Cowen.

Samuel Rollenhagen: This is Sam on for Tara. Can you hear me?

Jay Duker: Yes.

Samuel Rollenhagen: Congrats on another great enrollment update. So I just wanted to ask on safety for the LUGANO data. And if you could help us set some expectations there for what you're hoping to see. I guess, besides avoiding some of the more serious back of the eye events, are there any other AEs where you think DURAVYU could be differentiated versus competitors? And then also, it'd just be great if you could clarify how you're anticipating to disclose those safety data in the top line release? Will you be reporting all events or just those above a specific threshold?

Jay Duker: Thanks for the question, Sam. And so again, the -- one of the hallmarks of the current anti-VEGF approved drugs with perhaps one exception, is they're quite safe. And while patients and physicians will probably be willing to accept perhaps a few more AEs from a long-acting drug, there can't be a big difference. There's really a high bar that's out there for safety. And the good news is that all our safety from our 4 reported trials shows no real increase in any SAE or AE that would preclude our drug from being widely accepted, in our opinion. So from a safety perspective, again, a lot of the safety issues that can occur are injection related.

And if you're reducing the number of injections that a patient gets, then you're likely in the long term to have fewer adverse events. We hope to be able to show that in our pivotal trials. And from a reporting perspective, I don't know how granular the safety reporting will be initially, but we do expect to have complete AE tables when we present the data from LUGANO and LUCIA.

Operator: I'm showing no further questions in the queue at this time. Ladies and gentlemen, thank you for participating in today's conference. This does conclude your program, and you may now disconnect. Everyone, have a great day.