Earnings Call Transcript - EYPT Q1 FY2026

Operator

My name is Brittany, and I'll be your conference operator today. At this time, I would like to welcome everyone to the I-Point First Quarter 2026 Financial Results and Recent Corporate Development Conference Call. There will be a question and answer session to follow the completion of prepared remarks. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of iPoint.

George Elston, CFO

Thank you, and thank you all for joining us on today's conference call to discuss iPoint's first quarter, 2026, financial results and recent corporate developments. With me today is Dr. Jay Duker, President and Chief Executive Officer of iPoint. Jay will begin with a review of recent corporate updates and discuss our ongoing clinical programs for Duraview and WED-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. Romero 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.ipoint.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 in regulatory matters and timelines, 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 iPoint. Thank you, George. Good morning, everyone, and

Dr. Jay Duker, CEO

thank you for joining us. The start of 2026 for iPoint was marked by a strong quarter of consistent execution as we approach a pivotal inflection point for our lead program, Duraview. 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 three top line data and 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, de-risked, and patient-centric approach will continue to reinforce DuraVue's best-in-class potential in the two largest retinal disease markets. The fundamental strength of the DuraVue program lies in its robust and differentiated clinical data. In Phase II trials, a single dose of DuraVue demonstrated durable efficacy with improved vision and tight anatomic control. In over 190 patients across four completed clinical trials, DuraVue 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.

George Elston, CFO

Importantly, none of these discontinuations were related to treatment.

Dr. Jay Duker, CEO

At this stage, all patients across the Lugano and Lucia trials have reached the week 32 visit, during which patients in the DuraVue arms receive their second DuraVue dose. Over 35 percent of those patients have since received their third planned dose of DuraVue at week 56. As a reminder, we've received two 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 mass safety data will continue to remain consistent, further strengthening DuraVue's clinical profile. In addition, we believe the multi-mechanism of action, or MOA, of DuraVue's active ingredient virulinib will prove to be a key clinical differentiator. Along with blocking all VEGF isoforms and PDGF at the receptor level, preclinical data supports veroninib'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 provides sustained release efficacy, DuraVue 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 DuraVue's potential to improve long-term outcomes for patients. A primary kinase screen and subsequent measure of IC50 levels identified virulinib as a potent inhibitor of JAK1, which plays a critical role in IL-6-mediated inflammation. In addition, virolinib 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 Duraview 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 de-risked, following an established non-inferiority regulatory pathway. Both pivotal trials are identical and compare DuraVue to on-label 2 milligram of filibrocept, which is intended to reflect real-world practice and generate clinically relevant data to inform the retina community. Additionally, both trials evaluating six-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 DuraVue if approved. We look forward to reporting top-line data from our Phase III wet MD trial, Lugano, this summer, with our second trial, Lucia, to follow shortly thereafter. We're applying the same de-risk approach to our Phase III DME program, which leverages a non-inferiority design, an on-label 2 milligram of flibricep control, and redosing every six 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 DuraVue demonstrated rapid efficacy with four to five letters of vision improvement and approximately 50 micron improvement in anatomic control compared to a Flibercept at week four. Both of our DME trials, COMO and CAPRI, are now underway, with over one-third 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 DuraView 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, Duraview 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 Duraview and 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 preparedness to deliver due review to patients upon potential approval. Before passing it over to George to review the financials, I'd like to thank the entire iPoint 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 3 wet MD readouts, together with continued progress in our DME program, which we believe sets the stage for meaningful value creation at iPoint. I will now turn the call over to George.

George Elston, CFO

Thank you, Jay. As the financial results for the three 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 Utique 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 Duraview in both wet AMD and DME and the scale-up 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 equivalents and investments in marketable securities on March 31, 2026 totaled $223 million, compared to $306 million as of December 31, 2025. five. 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 three wet AMD program expected later this year. In conclusion, we're pleased with iPoint's progress so far in 2026 and remain well capitalized to deliver DuraVue through key value driving milestones in the two largest retinal disease markets. I will now turn the call back over to Jay for closing remarks.

Dr. Jay Duker, CEO

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 A&D 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 the Advancing Duraview as a potential first and best-in-class option in the two largest retinal disease markets. Thank you all for your attention this morning. I will now turn the call back over

Operator

to the operator for questions. Thank you so much. As usual, we'll try and get to as many questions as we can through the course of the call, but if you limit the number of questions you ask to one, It will give others a fair chance to participate. Our first question comes from the line of Tess Romero with J.P. Morgan. Your line is now open.

Tess Romero, Analyst — J.P. Morgan

Thanks so much. Hey, guys. Thanks for taking our question this morning. So just one from us on the DME side, actually. So for your POMO and the pretrials, 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 Duraview? What are the key differences and similarities that you hear in the DME space versus maybe what you heard in the wet AMD space? Thanks so much.

Dr. Jay Duker, CEO

Thanks for the question, Tess. given that our CMO, Romero Ribeiro, is really at the forefront of this. I'll ask

Dr. Romero Ribeiro, Other

him to answer your question. Hey, Tess. Good morning. Thanks for the question. So first, as you mentioned, we are seeing a great excitement around our DME program, Coleman Capri, with a quite quick enrollment so far. We are now leveraging all the infrastructure that we use for our WETMD with our clinical sites and our CRO and vendors as well. The feedback that we're getting from the investigators, very similar to our WETMD, 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 six months. In particular for the DME indication, we know that the need for this patient population might be even greater than WET-MD. 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 Duraview is of course of very interest for this patient population. Again, I think the excitement both from the investigators, the patient, the clinical side is being reflected in the pace of our enrollment.

Dr. Jay Duker, CEO

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 DuraVue.

Yigal Dov Nochomovitz, Analyst — Citigroup

Thank you.

Operator

Thank you so much. One moment for our next question. Our next question comes from the line of Yigel Noco-Movitz with Citigroup. Your line is now open.

Eddie (on for Yatin), Analyst — Guggenheim

Great. Thank you very much for taking the question. And 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-II 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.

Dr. Jay Duker, CEO

Yagal, nice to hear from you. Thanks for the question. And with respect to supplements, I'm going to have Romero comment in a moment about how that is working in the trial. But I think there's really two issues around the supplementation that people should understand. The first is that in the clinical trials, supplements will be handled statistically as sensitivity, 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 a 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 two MOAs to help across a chronic disease. That has been true across a lot of chronic diseases, where if two 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 two months with a biologic anti-VEGF, and let's hypothesize that DuraVue is FDA-approved, it's safe, it's tolerable, it has a label for every six months, and the patient gets shifted to DuraVue for the next year with two injections. But in addition, they receive two injections of a biologic. Well, it's a great win for everyone. The patient can go from every two months to every three months, from six injections to four injections, and that presumably the advantages of Duraview will be aligned with the patient and the doctor's interests. So there's 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.

Eddie (on for Yatin), Analyst — Guggenheim

Okay. Thank you. And then if I could just ask one other follow-up on DME. Of course, you've mentioned IL-6 as a potentially interesting biomarker. Are any of those IL-6 biomarker endpoints formally embedded in the Phase II DME program as sort of secondary

Dr. Jay Duker, CEO

endpoints that could help differentiate the product? 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 JAK-1, 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 four, the patients who received DuraVue had better vision and drier retinas as early as week four compared to a single dose of Aflibrecept. We have set up the COMO and COPRI trials to try to show that. And there is a secondary endpoint of visual acuity and OCT at week four, given our drug is given at day one in the DME trials. So that we hope to show that even if we're non-inferior and equivalent to ILEA, 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 jack 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's 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

Operator

inhibition. Thank you so much. Our next question comes from the line of Faisal Kershid with

Faisal Khurshid, Analyst — Jefferies

Jeffries. Your line is now open. Hey guys, thank you for taking the question. I just wanted to ask in the ongoing wet AMD studies, are you guys able to see blinded rescue rates and are those tracking in line with your expectations? Thank you. Thanks for the question, Faisal. Again,

Dr. Jay Duker, CEO

I'll let Romero talk about the supplementations and what we're seeing and what we're not seeing.

Dr. Romero Ribeiro, Other

Hey, Faisal. Thanks for the question. There's a very small team at iPoint that reviews the supplementation injections, and essentially to make sure that the clinical sites are following the protocol. But we don't review aggregated supplementation injection rate, and that's something that we don't disclose publicly.

Faisal Khurshid, Analyst — Jefferies

Makes sense. Thank you for taking the question.

Dr. Jay Duker, CEO

Well, and if I may add, we, again, as Romero indicated, have no insight into the number of supplements, supplementation rate, et cetera, at this point. It's all mass. 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 six, and the inclusion of the majority of naive patients. All of those together should result in fewer supplements in phase three. That's helpful context. Thank you. Thank you so

Operator

much. One moment for our next question, please. Our next question comes from the line of Yatin I'm sorry, Guggenheim, your line is now open.

Dr. Jay Duker, CEO

Yeah, hey, guys, this is Eddie on Friat, and thank you for taking my question. 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? Thank you so much. 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 Duravu is dry or wet or what the visual acuities are. So just like any drug, for example, take two milligram ilea, when it was first studied every two 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 the maximally tolerated dose of varolinib, and we've injected a scaled dose of about 10 times 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 mass safety. And I will once again turn to Romero If he wants to comment on the upcoming DMC meeting, that is going to be occurring shortly.

Dr. Romero Ribeiro, Other

Yeah, no, thanks. And thanks, Eddie, for the question. We, as Jay mentioned, safety is something that is, of course, paramount for iPoint, 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 the month of May, where the members will review our mass data, and we look forward to provide updates after that meeting. Great. Thank you.

Operator

Thank you so much. Our next question comes from the line of Dibinjana Chatterjee with Jones.

Yigal Dov Nochomovitz, Analyst — Citigroup

your line is now open. Hi, thanks for taking my question. So, what have you seen in the mass safety data set so far, and has anything shifted your expectations going into the DSMD review that is scheduled for late May? Thanks for the question, Tim and Jonna. And

Dr. Jay Duker, CEO

And we're not commenting on any individual SAEs or AEs. But in total, I would say and repeat what Romero said, what we've seen so far is consistent with what we've seen in the prior four trials. no new safety concerns and no incidents that we haven't seen or expected from before. Again, Romero, I don't know if you want to add any more color to what I said.

Dr. Romero Ribeiro, Other

Yeah, no, I think just again to reiterate safety at that point, Ms. Paramount, we internally review the data on an ongoing basis on a mask fashion and as Jay mentioned we have no safety signal. We haven't detected anything that is new. The safety profile continues to be very similar to what we saw in our previous completed

Yigal Dov Nochomovitz, Analyst — Citigroup

studies. Thank you. Just a very quick follow-up. Can we expect any form of public update following the DSMD meeting? Yes, I think it's likely that we

Operator

will give an update. Yes. Thank you. Bye. Thank you so much. Our next question comes from the line of Lisa Walter with RBC Capital Markets. Your line is now open. Oh, good morning. Thanks for

Lisa Walter, Analyst — RBC Capital Markets

taking our question and congrats on the progress. We have seen a long-acting TKI competitor have 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 timeframes, does perhaps having two 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

Dr. Jay Duker, CEO

this? Thanks again. Yeah, 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 multi-billion dollar market, and there is certainly room for two 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 mechanisms 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, we will have the opportunity from a commercial basis to really show that. Thanks for making my question. I

Operator

appreciate the feedback. Thanks, Lisa. Thank you so much. Our next question. It comes from the line of Nick for Colleen Cussie with Bayer. Your line is now open.

Nick (on for Colleen Cussie), Analyst — Bayer

Hey, everyone. It's Nick on for Colleen. Thanks for taking the question. So just at ARVA and other recent scientific conferences, just wanted to ask just what the takeaways were on DuraVue sentiment among physicians and if you got any learnings about how physicians intend on using their review upon a potential

Dr. Jay Duker, CEO

approval. Thank you. 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, virulinib, the active ingredient in EYP1901, 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 virulinib 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. Romero met with multiple KOLs at Arvo, and I will let him weigh in on what the sentiment seems to be around EYP 1901.

Dr. Romero Ribeiro, Other

Yeah, no, thanks, Nick, for the question. And we had a very productive hour vote 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 3 WFND and DME investigator. I think first on the sentiment of the clinical trials, I think everybody, of course, is very excited for the upcoming data for Lugar and Lucia, mentions of, you know, 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 DuraVue, as Jay mentioned previously in the call, they expressed the important of MAD need that we're trying to address with DuraVue. When they see this, if we can replicate the results that we saw in the Phase 2 study, that's something that is going to be very meaningful for patients, especially for those patients that require frequent treatment.

Nick (on for Colleen Cussie), Analyst — Bayer

Great. Thanks, y'all. Thanks for taking the question. Congrats on the progress.

Yale Jin, Analyst — Laidlaw

Thank you.

Operator

Thank you so much. Our next question will be coming from the line of Yale Gin with Laylaw. Your line is now open.

Yale Jin, Analyst — Laidlaw

Good morning, and thanks for taking the question. 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, the BISMO and the high-dose ILEA, which one Or do you think you, if approved, will be competing more or less? And any comment on that?

Dr. Jay Duker, CEO

Thanks for the question, Yael. It's an important question because these are excellent medications that are multi-billion 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 two data that at least two-thirds of the wet MD population could be treated with our drug alone every six 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, the real world data is suggesting that most patients are getting about a week or two 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 six-month or longer medication. 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

Michael Campbell, Other

competition? Yeah, 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 eight days, we also look at what the retina specialists are saying in the community and where the needs are. And so if you if you look at the American Society of Retina Specialists, ASRS, every year they put out a PAT survey. And very consistently, the number one need in wet AMD treatments that is reported from ASRS is still durability, even with Babismo and Ileah HD in the market. So to Jay's point, there is a very clear opportunity. Should DuravU be successful and be approved, there's a very clear opportunity for room in this market for more durable agents great uh thanks a lot all right

Operator

thank you so much our next question comes from the line of samuel roland hagen with td cohen

Sam Roland-Hagen, Analyst — TD Cowen

your line is now open hi guys this is sam on for tara can you hear me yes hi sam great um well thanks for taking our question and 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 dare view could be differentiated versus competitors and then also it would just be great if you could clarify how you are anticipating to disclose those safety data in the top line release will you be reporting all events or just those above a specific

Dr. Jay Duker, CEO

threshold? Thanks. Thanks for the question, Sam. And so, again, 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 four 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 in our pivotal trials uh and from a reporting perspective uh i don't know uh 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 got it very helpful thank you thank you so much

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