5/6/2026

speaker
Brittany
Conference Operator

Okay, and our next question comes from the line of Tess Romero with JP Morgan. Our next question comes from the line of Tess Romero with JP Morgan.

speaker
Brittany
Conference Operator

Good morning. My name is Brittany, and I'll be your conference operator today. At this time, I would like to welcome everyone to the iPoint 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.

speaker
George Elston
Executive Vice President & Chief Financial Officer

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-Ribero, 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 and 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.

speaker
Dr. Jay Duker
President & Chief Executive Officer

Thank you, George. Good morning, everyone, and 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, Duravu. 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 three 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 the review's best-in-class potential in the two largest retinal disease markets. The fundamental strength of the DuraView program lies in its robust and differentiated clinical data. In phase two trials, a single dose of DuraView demonstrated durable efficacy with improved vision and tight anatomic control. In over 190 patients across four completed clinical trials, DuraView has demonstrated a consistently favorable safety profile with no safety signals. That profile continues to hold in our ongoing phase three 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 DuraView arms received their second DuraView dose. Over 35% of those patients have since received their third planned dose of DuraView 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 DuraView's clinical profile. In addition, we believe the multi-mechanism of action, or MOA, of DuraView's active ingredient, virolinib, will prove to be a key clinical differentiator. Along with blocking all VEGF isoforms and PDGF at the receptor level, Preclinical data supports for Roland'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, DuraView 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 substantiates the review's potential to improve long-term outcomes for patients. A primary kinase screen and subsequent measure of IC50 levels identified Virolinib as a potent inhibitor of JAK1, which plays a critical role in IL-6-mediated inflammation. In addition, Virolin 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 Duravu 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 DuraView 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 are 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 DuraView, 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 de-risk approach to our Phase III DME program, which leverages a non-inferiority design, an unlabeled two milligram of Flibercept 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 DuraView 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 WebAMD 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 Duravue 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 DuraView 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 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 three 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.

speaker
George Elston
Executive Vice President & Chief Financial Officer

Thank you, Jay. As the financial results for the three months ended March 31st, 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. 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 agreements in the second quarter of 2023 for the license of Utique Product Rights. Operating expenses for the quarter ended March 31st, 2026 totaled $88 million compared to $73 million in the prior year period. This increase was primarily driven by the ongoing phase three trials for door review 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 99 cents per share compared to a net loss of 45 million or 65 cents per share for the prior year period. As I noted earlier, cash equivalents and investments in marketable securities on March 31st, 2026 totaled 223 million compared to 306 million as of December 31st, 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 I-Point's progress so far in 2026 and remain well capitalized to deliver DuraView 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.

speaker
Dr. Jay Duker
President & Chief Executive Officer

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 and wet A&D expected midyear 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 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 to the operator for questions.

speaker
Brittany
Conference Operator

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 JP Morgan. Your line is now open.

speaker
Tess Romero
Analyst, JP Morgan

Great. 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 COMO 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 Duravue? 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.

speaker
Dr. Jay Duker
President & Chief Executive Officer

Thanks for the question, Tess. Given that our CMO, Romero-Rivera, was really at the forefront of this, I'll ask him to answer your question.

speaker
Dr. Romero-Ribero
Chief Medical Officer

Hey, Tess. Good morning. Thanks for the question. So first, as you mentioned, we are seeing a great excitement around our DME program, Common Copy, with a quite quick enrollment so far. We are now leveraging all the infrastructure that we use for our WAC-MD with our clinical site and our CRO and vendor as well. The feedback that we're getting from the investigators, very similar to our YTMD, 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 DuraVu, is, of course, of very interest for this patient population. Again, I think the excitement both from the investigators

speaker
Dr. Jay Duker
President & Chief Executive Officer

patient clinical site is being reflected in the pace of our enrollment 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 the review.

speaker
Unknown Participant

Thank you.

speaker
Brittany
Conference Operator

Thank you so much. One moment for our next question.

speaker
Brittany
Conference Operator

Our next question comes from the line of Eagle. No, no. With Citigroup, your line is now open.

speaker
Citigroup Analyst
Analyst, Citigroup

Great. Thank you very much for taking the questions. I'm just wondering if you could comment on how the supplement trigger criteria are functioning in the Phase 3 trial relative to the Phase 2 trial, the W02 trial, and if you could also comment on what you would expect to be a meaningful supplement rate in the Phase 3 trial that would be consistent with a strong commercial uptake. Thank you.

speaker
Dr. Jay Duker
President & Chief Executive Officer

Yagal, nice to hear from you. Thanks for the question. 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 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 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 DuraView is FDA approved, it's safe, it's tolerable, it has a label for every six months. And the patient gets shifted to DuraView 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 Duravue 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.

speaker
Citigroup Analyst
Analyst, Citigroup

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 endpoints that could help differentiate the product?

speaker
Dr. Jay Duker
President & Chief Executive Officer

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 four, the patients who received DuraView had better vision and drier retinas as early as week four compared to a single dose of Aflibricept. We have set up the COMO and Cochrane 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 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 Aflivercept control. And that's the kind of secondary endpoint that if we can show reduction in leakage greater than a Flibercept, I think the evidence would lead to that is due to IL-6 inhibition.

speaker
Brittany
Conference Operator

Thanks. Thank you so much. Our next question comes from the line of Faisal Khurshid with Jefferies. Your line is now open.

speaker
Faisal Khurshid
Analyst, Jefferies

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.

speaker
Dr. Jay Duker
President & Chief Executive Officer

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

speaker
Dr. Romero-Ribero
Chief Medical Officer

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 supplement injection rate, and that's something that we don't disclose publicly.

speaker
Faisal Khurshid
Analyst, Jefferies

Makes sense. Thank you for taking the question.

speaker
Dr. Jay Duker
President & Chief Executive Officer

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 masked. But we do anticipate that the supplementation rates in the phase three trials will be less than what we saw in the phase two 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.

speaker
Faisal Khurshid
Analyst, Jefferies

That's helpful context. Thank you.

speaker
Brittany
Conference Operator

Thank you so much. One moment for our next question, please.

speaker
Brittany
Conference Operator

Our next question comes from the line of Yatin Sanija with Guggenheim. Your line is now open.

speaker
Jay

Yeah, hey guys, this is Eddie on Friot, 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, you know, further has the FDA weighed in on how this complicates the retreatment redosing schedule? Thank you so much.

speaker
Dr. Jay Duker
President & Chief Executive Officer

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 Duravue 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 rolinib. 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 mask 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.

speaker
Dr. Romero-Ribero
Chief Medical Officer

Romero- Yeah, no, thanks. And thanks, Eddie, for the question. We, as Jay mentioned, safety is something that is, of course, paramount for I-Point, and we conduct ongoing safety review of the data. If you do the math, we have now had patients that reached that week 56 visit that you mentioned, which is the third dose of EYP19-1, 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 mask data and we look forward to provide updates after that meeting.

speaker
Jay

Great, thank you.

speaker
Brittany
Conference Operator

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

speaker
Unknown Participant

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

speaker
Dr. Jay Duker
President & Chief Executive Officer

Thanks for the question, Devanjana. 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.

speaker
Dr. Romero-Ribero
Chief Medical Officer

Yeah, no, I think just, again, to reiterate safety at that point is paramount. We, internally, we reviewed the data on an ongoing basis on a mass profession. 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 studies.

speaker
Unknown Participant

Thank you. Just a very quick follow-up. Can we expect any form of public update following the DSMD meeting?

speaker
Dr. Jay Duker
President & Chief Executive Officer

Yes. I think it's likely that we will give an update. Yes.

speaker
Unknown Participant

Thank you. I'll be back in a minute. Bye.

speaker
Brittany
Conference Operator

Thank you so much. Our next question comes from the line of Lisa Walter with RBC Capital Markets. Your line is now open.

speaker
Lisa Walter
Analyst, RBC Capital Markets

Oh, good morning. Thanks for 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 this? Thanks again.

speaker
Dr. Jay Duker
President & Chief Executive Officer

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 TKAIs are going into a multibillion-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.

speaker
Brittany
Conference Operator

Hi, Lisa.

speaker
Lisa Walter
Analyst, RBC Capital Markets

Thanks for taking my question. I appreciate the feedback.

speaker
Dr. Jay Duker
President & Chief Executive Officer

Thanks, Lisa.

speaker
Brittany
Conference Operator

Thank you so much. Our next question comes from the line of Nick for Colleen Cussey with Bayard. Your line is now open.

speaker
Nick (for Colleen Cussey)
Analyst, Bayard

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 what the takeaways were on derivative sentiment among physicians and if you got any learnings about how physicians intend on using derivative upon a potential approval. Thank you.

speaker
Dr. Jay Duker
President & Chief Executive Officer

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, virolinib, 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 virolinib 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.

speaker
Dr. Romero-Ribero
Chief Medical Officer

Yeah, 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 Western D&D investigators. I think first on the sentiment of the clinical trials, I think everybody, of course, is very excited for the upcoming data for Lugana 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 DuraView, as Jay mentioned previously in the call, they expressed the important NOMAD need that we're trying to address with DuraView, 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.

speaker
Brittany
Conference Operator

Thanks for taking the question. Congrats on the progress.

speaker
Brittany
Conference Operator

Thank you.

speaker
Brittany
Conference Operator

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

speaker
Yale Jin
Analyst, Laylaw

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 bismuth and the high-dose ilea, which one do you think Dervil, if approved, will be competing more or less? And any comments on that? Anything?

speaker
Dr. Jay Duker
President & Chief Executive Officer

Thanks for the question, Yang. 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 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 gonna 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.

speaker
Michael Campbell
Chief Commercial Officer

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 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 the BiSMO and ILEA-HD in the market. So to Jay's point, there is a very clear opportunity. Should Duravue be successful and be approved, there's a very clear opportunity for room in this market for more durable agents.

speaker
Yale Jin
Analyst, Laylaw

Great. Thanks a lot.

speaker
Brittany
Conference Operator

All right. Thank you so much. Our next question comes from the line of Samuel Roland Hagan with TD Cohen. Your line is now open.

speaker
Sam
Analyst, TD Cowen

Hi, guys. This is Sam on for Tara. Can you hear me?

speaker
George Elston
Executive Vice President & Chief Financial Officer

Yes. Hi, Sam.

speaker
Sam
Analyst, TD Cowen

Great. 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 DaraView could be differentiated versus competitors? And then also, it would just be great if you could clarify how you were anticipating to disclose those safety data in the top line release. Will you be reporting all events or just those above a specific threshold?

speaker
Dr. Jay Duker
President & Chief Executive Officer

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 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.

speaker
Sam
Analyst, TD Cowen

Got it. Very helpful. Thank you.

speaker
Brittany
Conference Operator

Thank you so much. 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.

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