Earnings Call Transcript
EyePoint, Inc. (EYPT)
Earnings Call Transcript - EYPT Q2 2025
Operator, Operator
Good morning. My name is Antoine, and I'll be your conference operator today. At this time, I would like to welcome everyone to the EyePoint Second Quarter 2025 Financial Results and Recent Corporate Developments Conference Call. 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 EyePoint.
George O. Elston, Executive Vice President and CFO
Thank you, and thank you all for joining us on today's conference call to discuss EyePoint's second quarter 2025 financial results and recent corporate developments. With me today is Dr. Jay Duker, President and Chief Executive Officer of EyePoint. Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for DURAVYU in wet age-related macular degeneration or wet-AMD. I will close with commentary on the second quarter 2025 financial results, and we will then open the call for your questions. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found on the Investor Relations tab on the company website, www.eyepointpharma.com. 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 may 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 S. Duker, President and CEO
Thank you, George. Good morning, everyone, and thank you for joining us. I am pleased to share our key updates for the second quarter, particularly the significant advancements in our Phase III clinical program for our lead asset, DURAVYU, in wet age-related macular degeneration (wet-AMD). Since January 2021, when we dosed the first patient with DURAVYU in our Phase I DAVIO trial, our unwavering focus and excellent execution have enabled us to achieve full enrollment in both Phase III pivotal trials for wet-AMD in just over 4.5 years. This progress underscores EyePoint's leadership in drug development and commitment to the retinal community. Before diving into the specifics of the past quarter, I want to highlight how far we've come as a company in a short time. We have successfully transitioned to a clinical-stage biopharmaceutical firm, emphasizing DURAVYU's development as a new treatment option for the largest retinal disease markets, wet-AMD and diabetic macular edema (DME), while stepping away from the specialty pharma business. We conducted four clinical trials for DURAVYU, including three Phase II studies, treating more than 190 patients with DURAVYU across various retinal conditions, establishing a solid and favorable safety profile that inspires physicians to participate eagerly in our pivotal program. We've created the most comprehensive data set among ongoing sustained-release therapies for wet-AMD, showcasing remarkably effective Phase II data that demonstrate non-inferior visual acuity compared to on-label aflibercept while significantly reducing treatment burden by over 80%. With this robust efficacy profile and patient-focused pivotal trial design, we completed enrollment for Phase III trials in a record timeframe, with over 800 patients enrolled across the LUGANO and LUCIA trials. Due to rapid enrollment and an efficient trial setup, we are positioned to deliver top line data from LUGANO in mid-2026, with LUCIA data expected soon after, allowing us potentially to be first to file and first to market among investigational sustained-release therapies for wet-AMD. We are also enhancing DURAVYU's clinical profile beyond wet-AMD, reporting promising results in the Phase II VERONA trial for DME, paving the way for a pivotal program in this emerging indication. In anticipation of commercial success, we have invested in a state-of-the-art 41,000 square-foot cGMP manufacturing facility in Northbridge, Massachusetts, to support the commercial production of DURAVYU, with registration batches currently in progress for an anticipated NDA filing and pre-approval inspection. We have also strengthened our balance sheet by eliminating debt and extending our cash runway into 2027, well beyond the pivotal wet-AMD data deadline in 2026. I am incredibly proud of the speed and quality of these accomplishments, and we remain committed to continuing this momentum. Now let’s take a closer look at wet-AMD. This market is valued at $10 billion and continues to grow in the United States, primarily dominated by a single treatment type, monotherapy with anti-VEGF biologics. Though effective, patients with wet-AMD often experience long-term vision loss. Newer therapies that aim for up to four months of visual stabilization have similar limitations and usually require more frequent injections to maintain stable vision. Given these constraints, improving durability is crucial for physicians in selecting wet-AMD therapies and highlights an area ripe for innovation. Our lead candidate, DURAVYU, represents a significant shift in treatment paradigms combined with a new mechanism of action to address this need. Supported by durable efficacy lasting at least six months and a consistent safety profile, along with unique storage and administration advantages, we believe DURAVYU delivers a distinct product profile that is significant for both physicians and patients. If approved, it could ensure a strong competitive position in the wet-AMD landscape. Let me explain the key aspects that set DURAVYU apart. First, DURAVYU is not simply another anti-VEGF biologic or ligand-blocking therapeutic like existing products on the market. It is a clinically validated sustained-release tyrosine kinase inhibitor (TKI) that introduces a new mechanism of action, potentially complementing current anti-VEGF biologics to achieve more durable disease control and lessen treatment burdens. DURAVYU features the potent and selective TKI vorolanib, which operates intracellularly to obstruct all VEGF receptors and the PDGF receptor, formulated with our bioerodible Durasert E technology. Durasert E is an advanced bioerodible sustained-release insert designed to avoid free-floating drug particles and contains neither PEG nor PLGA. Second, in contrast to other sustained delivery therapies under development, DURAVYU can be shipped and stored at room temperature. Following standard practice, DURAVYU will be administered in a physician's office via a standard intravitreal injection using a preloaded sterile syringe injector. Importantly, due to its innovative mechanism of action, DURAVYU could potentially provide stable vision and retinal anatomy with dosing every six months, a schedule likely to improve long-term compliance among wet-AMD patients. The clinical data we have accumulated thus far suggests that DURAVYU could significantly alter the wet-AMD treatment landscape, and our Phase III program is designed to rigorously validate this through a well-structured but low-risk approach. Our Phase III LUGANO and LUCIA trials are double-masked and non-inferiority trials created in close collaboration with the FDA, including written agreement from the agency to facilitate a clear approval pathway and an enticing label. Furthermore, the trials are designed with patients in mind, allowing all participants to receive treatment aimed at maintaining or improving vision. They follow a validated design to assess non-inferiority against on-label two-milligram aflibercept. The use of on-label standard care as a control is a fundamental aspect of FDA guidance crucial to the trials' non-inferiority design. Importantly, retinal specialists routinely utilize non-inferiority trial data to inform their prescribing choices, as seen with the previous four wet-AMD approvals in the United States which followed this approach. Additionally, including both treatment-naive and previously treated patients broadens the applicability of our data, potentially leading to a wider label that could drive higher physician adoption. Should we receive approval, our label is expected to feature a differentiated six-month dosing interval, representing a considerable advancement over current anti-VEGF treatments in the United States that are typically administered every two months. Fueled by the evident market demand for more durable wet-AMD therapies, DURAVYU's patient-focused trial design, robust Phase II clinical data set, and exceptional safety record have allowed us to enroll and randomize over 800 patients in the LUGANO and LUCIA trials. LUCIA also signifies our global expansion with trial sites in South America, Europe, Israel, Australia, and India, demonstrating ongoing momentum and demand from the global wet-AMD patient community for DURAVYU. We take pride in the clinical rigor of our Phase III program, highlighted by the approvals from both the FDA and EMA, the two largest regulatory bodies globally, confirming our protocol, and we have surpassed our enrollment timelines without major alterations to our trial design. With the primary 56-week endpoint for both trials, we expect to see top line data from LUGANO in mid-2026, with LUCIA data to follow closely, which bolsters our confidence in securing first-to-file and first-to-market status among current investigational sustained release therapies. The consistently positive feedback from physicians and patients continues to solidify our belief in DURAVYU's distinguished profile and its future commercial success. As part of our efforts to maintain a first-mover advantage, we have made significant headway in our commercial preparedness while remaining focused on prudent investments. Our cutting-edge cGMP commercial manufacturing facility in Northbridge, Massachusetts is equipped to meet upcoming commercial demands. In support of a potential NDA filing, registration batches for DURAVYU are currently in production. Moreover, we have strategically expanded our team to bolster key areas such as late-stage clinical development, regulatory affairs, pharmacovigilance, biometrics, and medical affairs, while remaining financially disciplined. As we prioritize advancing our wet-AMD program towards top line data and an NDA filing, we are also happy to report progress in DME, the second largest retinal disease indication. Affecting around 25% of diabetic patients, DME is projected to represent a $3 billion market opportunity in the United States by 2030. Like wet-AMD, the regular burden of anti-VEGF injections results in missed doses and vision loss, highlighting the need for more durable therapies. Following the strong safety and efficacy results of our Phase II VERONA trial in DME earlier this year, we held a productive end-of-Phase II meeting with the FDA to align our future pivotal program. We look forward to sharing more details about our pivotal plans in the coming months. In summary, with top line data for LUGANO and LUCIA expected in 2026 and a pressing need for safe, effective, and more durable treatment options for wet-AMD and DME, EyePoint is well-positioned to remain a leader in sustained-release drug delivery for retinal diseases as we collaborate with the retinal community to enhance patients' lives and generate long-term value. Our extensive clinical experience, advanced technology, and the blockbuster potential of the DURAVYU franchise illustrate our exciting growth narrative. Before I hand it over to George to discuss our financials, I want to express my gratitude to the entire EyePoint team for their dedication to our mission of enhancing patients' lives through better vision, as well as to the patients and clinical investigators engaged in our trials. We genuinely appreciate your trust in us, and we are committed to advancing our therapeutics for the benefit of the broader retinal community. We look forward to making continued strides towards our upcoming milestones as we establish our leadership in sustained ocular drug delivery. Now, I'll turn the call back to George.
George O. Elston, Executive Vice President and CFO
Thank you, Jay. To begin, we continue disciplined financial management and good stewardship of our cash, ending the second quarter with $256 million in cash and investments. Of note, as Jay just mentioned, the rapid enrollment of over 800 patients in the LUGANO and LUCIA trials accelerated our planned use of cash into the first half of 2025. The trial enrollment was well ahead of our expectations, and the associated burn is included in our plan and cash runway guidance. Now that we have completed full enrollment for both trials, we expect cash burn to meaningfully decline in the second half of 2025. Accordingly, we affirm previous cash runway guidance and expect cash will support our operations into 2027 well beyond key data readouts for our Phase III wet-AMD program in 2026. As the financial results for the three months ended June 30, 2025, were included in the press release issued this morning, my comments today will focus on a high-level review for the quarter. For the quarter ended June 30, 2025, total net revenue was $5.3 million compared to $9.5 million for the quarter ended June 30, 2024. Net revenue from license and royalties for the quarter ended June 30, 2025, totaled $5.3 million compared to $8.4 million in the corresponding period in 2024. The decrease was primarily driven by lower recognition of deferred revenue related to the agreement to license YUTIQ product rights completing our exit from Specialty Pharma. Operating expenses for the quarter ended June 30, 2025, totaled $67.6 million, compared to $44 million in the prior year period. This increase was primarily driven by the increase in clinical trial costs related to the ongoing Phase III LUGANO and LUCIA clinical trials of DURAVYU for wet-AMD. Net nonoperating income totaled $2.9 million and net loss was $59.4 million, or $0.85 per share compared to a net loss of $30.8 million, or $0.58 per share for the prior year period. As I noted earlier, cash and cash equivalents and investments in marketable securities on June 30, 2025, totaled $256 million compared to $371 million as of December 31, 2024. And again, we affirm cash guidance unchanged into 2027. In conclusion, we're incredibly pleased with EyePoint's progress so far in 2025 and remain well capitalized to deliver DURAVYU Phase III data in 2026. I'll now turn the call back over to Jay for closing remarks.
Jay S. Duker, President and CEO
Thank you, George. As you've heard this morning, we ended the second quarter in a phenomenal position, and we remain focused on advancing DURAVYU, a best-in-class program in wet-AMD. With our strong balance sheet and clear development strategy, we are prepared to execute through our upcoming key milestones, including top line data for the Phase III LUGANO trial anticipated in mid-2026, with LUCIA to closely follow. An NDA submission for DURAVYU in wet-AMD, assuming positive data and continued updates on the DME program, including a presentation of the Phase II VERONA end-of-study results at the Retina Society Annual Meeting in September. Our 2025 progress to date reflects our dedication to advancing our pipeline and delivering innovative treatments for serious retinal diseases, and we are excited to continue our momentum throughout the second half of the year. Thank you all very much for your attention this morning. I will now turn the call over to the operator for your questions.
Operator, Operator
Operator Instructions Our first question comes from Tess Romero from JPMorgan.
Tessa Thomas Romero, Analyst
So maybe you could speak a little bit to overall trial conduct of these two pivotal studies in wet-AMD and what you're really focused on getting right to mitigate any key risks.
Jay S. Duker, President and CEO
Thanks for the question, Tess. Nice to hear from you. That's really a question I think Ramiro, our Chief Medical Officer, can answer best because this is obviously what he is now focusing on and will be focusing on over the next year, given that we are now fully enrolled. So Ramiro, do you want to take that question?
Ramiro Ribeiro, Chief Medical Officer
Thank you for the question, Tess. One advantage that EyePoint has is our strong Phase III study experience with our 1901 DURAVYU. As Jay mentioned, we executed well on enrollment and completed it for both studies ahead of schedule. Now, our focus is on study conduct. We are collaborating closely with clinical sites and investigators to ensure there are no deviations from the protocol. Additionally, we are tracking patient safety in the study, which is crucial. Our collaboration with our CRO is also strong, helping us conduct the study effectively. Moving forward, our priority is to ensure excellent execution over the next 12 months and prepare for our top line results, including an on-time database lock and other necessary activities.
Jay S. Duker, President and CEO
And maybe if I could add just a little bit more about our protocol. Once again, this noninferiority trial design is something that retinal physicians are really used to. Our control group is on label. And the study design, again, is simple for the sites and the patients to understand. So I think all of this helps keep patients in the trial. And our dropout rate is quite low in both trials, less than 2% currently. So from that regard, we're doing really, really well also.
Operator, Operator
Our next question comes from Jennifer Kim from Cantor Fitzgerald.
Jennifer M. Kim, Analyst
Congrats on the continued execution, the delivery and consistency of these trials has been refreshing to see. Maybe to start off, I know you said you've talked about not disclosing certain masked data in the Phase IIIs and avoiding introducing operational bias. Is there a line that would concern regulators in terms of introducing bias? And are you able to say anything on the cadence of, say, supplemental rescues as far as whether they've stayed within expectations? Maybe we can start there.
Jay S. Duker, President and CEO
Yes. Good question, Jennifer. Thanks for that. So I think at a high level, talking about masked demographics such as age, sex, OCT visual acuity of the patients that have been enrolled is not really any risk. And we will likely do that in the future prior to top line data. On the other hand, what we wouldn't want to do is introduce bias that would cause investigators or patients to alter their behavior. There really isn't any reason for us in my mind to put that risk into our trial results at this point. So while we may, under circumstances in the future, rethink this, right now, things are going so well that we wouldn't want to introduce unnecessary risk into the studies. And once again, Ramiro, if you want to give a little more color on that or any more detail, please feel free.
Ramiro Ribeiro, Chief Medical Officer
No, I think you covered well. And of course, we have a lot of the mechanics to make sure that the safety of the patients is going well, including an independent data monitoring committee that assesses the safety of our study on an independent matter. And we issued that press release included that information that the safety of whichever brand is going as we expected as well as our Phase II study. But as Jay mentioned, we want to make sure we don't introduce unnecessary bias in the study that is going so well so far.
Jennifer M. Kim, Analyst
Okay. That's helpful. And my second question is actually related to that. Should we expect a regular cadence of safety updates like on a quarterly or some periodic basis?
Jay S. Duker, President and CEO
Well, I think we will give periodic updates. We haven't really discussed internally if there will be a cadence. We'll cover that in the future. And yes, I think it's quite likely that we will give periodic updates to the safety database as we hear from the Data Safety Monitoring Committee.
Operator, Operator
Our next question comes from Tyler Van Buren from TD Cowen.
Tyler Martin Van Buren, Analyst
Congratulations on the tremendous enrollment for both LUGANO and LUCIA. Can you just elaborate on the rescue criteria for the trials, especially given the recent competitive updates and how that aligns with what is seen in the real world?
Jay S. Duker, President and CEO
Thanks for the question, Tyler. I'll actually address the second part of your question first. And again, if you talk to retina specialists and you ask them about the supplemental criteria in any one study, their first reaction is, well, that's not what I do in the real world. And the issue is that in the real world, giving an additional injection is something that is very much individualized to the patient. What's their vision? How is the other eye doing? Do they notice a change? A myriad of things that individualize treatment for patients. But for a study, you can't do that. You need to have strict guidelines, especially in a pivotal program about when a rescue or supplemental injection is given. So as we have disclosed publicly in the past, our Phase III supplement criteria, we think is very straightforward. If a patient loses more than five letters with 75 microns of new fluid over best on study due to wet-AMD, they should be rescued. And that's been consistent from the start of the trial; we haven't amended that. In addition, we have a second criteria, which is new site-threatening hemorrhage that is caused by wet age-related macular degeneration. And we've set up a system that's working, we think, quite well with injection monitors, and we've asked the sites to call one of these monitors, and they've been excellent about getting on the line with the sites right away to discuss potential rescue over a hemorrhage. That needs to include a fundus photograph. And the reason we did that was when we looked at our Phase II data, in the DAVIO 2 wet-AMD trial, there were nine patients who were rescued in all three groups total for hemorrhage. Well, when we looked at the fundus photographs and the clinical situation with our KOLs and our advisers, six out of nine of those eyes either didn't have a hemorrhage or the hemorrhage was not due to wet-AMD, or was not site threatening. So we really want to only rescue the patients who need it and are going to benefit from it and not rescue patients who do not. And therefore, again, this was Dr. Ribeiro's evaluation of the rescues in the Phase II. We don't have a criterion for fluid alone. We don't have a criterion for visual acuity loss alone because in those situations, what we saw in the Phase II is a rescue injection didn't help. And in the Phase II, 20% of the rescues were not per any of the protocol rescue requirements. They were due to physician discretion. And we've removed physician discretion in the Phase III.
Operator, Operator
Our next question comes from Yigal Nochomovitz.
Yigal Dov Nochomovitz, Analyst
I had two questions. One on the endpoint. There's been some chatter in the marketplace with respect to the blended versus the single time point. I'm just wondering, if you could comment, Jay, on that point. And is this a detail that the retina professionals really even care about whether you happen to average two very close points in time versus a single point in time? And then also just looking ahead to the potential launch, assuming everything goes well with the studies, is this a situation where once you get to the label, you can just launch immediately? Or is it a situation where you would wait until you have the label language in hand and then there'd be a period of time where you have to do the final fill and finish label printing and so forth and then launch some period of time after actually the PDUFA?
Jay S. Duker, President and CEO
Great. Thanks, Yigal. Two good questions. So, the blended endpoint was a regulatory, let's call it, strong suggestion. In fact, in our 2022 Type C meeting on our pivotal program, they insisted on it. And that's why we did a blended endpoint in our Phase II trial. This was reiterated again at our end of Phase II meeting in 2024 with the agency. And so, we obviously put that into our trial. We think the blended endpoint is a good thing. We think it decreases variability, and it decreases the risk of missing your primary endpoint. This blended endpoint also will help ensure that there is no missing data at the end of the trial. Obviously, if a patient makes one of those two blended visits but misses the other, there's a way we statistically handle that versus if they miss the single endpoint entirely. So overall, the agency strongly suggested it, and we did it, and we're very happy that we did it. And we think this is another point of our protocol that is derisking. In addition, I have to add the blended endpoint has been used in most recent studies. This isn't new or unique. So, your second question about timing of launch. At this point, should our trials be successful and our NDA approved, we are working diligently towards an immediate launch after approval.
Operator, Operator
Our next question comes from Debanjana Chatterjee.
Debanjana Chatterjee, Analyst
So with the first readout expected in mid-2026 and the second to follow shortly after, could you give us like any more color into your regulatory plans on how you'll gather the data and how soon you can submit? And maybe could you also comment on the scope of the safety package that the FDA would like to see with the initial filing?
Jay S. Duker, President and CEO
Sure. Thank you for that question. So now that we are fully enrolled in both studies in record time, Ramiro and his clinical group are really focused on ensuring that the data is sound, as we discussed earlier, and preparing for the NDA submission. So again, we expect top line data from the first trial to be summer of next year with the second trial, again, to follow shortly. I'm going to let Ramiro talk about some of the efforts around rapid NDA filing that we are working on.
Ramiro Ribeiro, Chief Medical Officer
Yes. Thanks for the question. As Jay mentioned before, our expertise and our strain is on the execution. So, the same way that we were able to execute rapidly on the enrollment, our aim is also to make sure that we do an NDA ahead of schedule. We have two identical non-inferiority studies. And this really gives the benefit of looking at the results from the first study from LUGANO doing some learnings there. And then when we get the results from LUCIA, be able to accelerate the interpretation and the write-up of those results, again, because both studies are identical. In terms of the safety package, as any other NDA submission, this is going to include the results from our Phase I, Phase III study as well as the combination of the Phase III program. And we should have enough patients to meet the requirements for the FDA for this type of indication.
Jay S. Duker, President and CEO
I want to expand on what Ramiro mentioned regarding our numbers. The FDA has consistently stated the need for a wet-AMD safety database that includes 300 evaluable patients at the specified dose and interval for your label. If you present with only 299 patients, it will not be accepted. This is reflected in the draft guidelines, which recommend enrolling 400 patients in your trials at the desired dose and interval to account for attrition. Therefore, we will have over 400 patients across both trials at the six-month dosing and the 2.7 milligram dose. We are confident in the safety database we will provide. I also want to note that we can file after one year, specifically after 56 weeks, but both trials will include a second year solely focused on safety, after which we plan to file an SNDA for the extension. If you have another question, please go ahead.
Debanjana Chatterjee, Analyst
Yes. Just a very quick one on filing. So, could you please remind us what could be the advantage of filing the traditional way versus the 505(b)(2) pathway that some competitors are talking about that while the traditional one might be slightly longer, are there distinct advantages that you get there?
Jay S. Duker, President and CEO
My understanding is that if you are filing with a drug that has already been approved, there is a potential two-month savings compared to the traditional pathway. Recently, the FDA has publicly discussed ways to accelerate the pathway, and we will certainly consider those options for our filing. If you have a compound that is already approved but are now combining it with a device, there are specific regulations regarding what you need to file for that combination. We also need to conduct the same necessary clinical studies and provide the CMC package. Therefore, there is a small potential for savings, but we are quite confident, given our rapid enrollment rate, that we will be the first to file and, if accepted, the first to receive approval and launch among all currently studied sustained-release products in the marketplace or potential marketplace.
Operator, Operator
Our next question comes from Lisa Walter from RBC.
Lisa A. Walter, Analyst
Maybe just on the pivotal trial progress. Should we expect any other updates beyond safety, like patient retention perhaps between now and when the pivotal trials begin to read out in mid-2026? And also, just curious if you are planning to run an open-label extension study for DURAVYU.
Jay S. Duker, President and CEO
Thanks for the questions. The second one is easy. Yes, we will do an extension study. We're in the midst of really planning that out, and we think that will provide tremendous value for practitioners and patients to understand the long-term benefits of DURAVYU. So that is in the planning. As for pivotal trial progress, again, I do expect that we will give an update on the basic demographics of the enrolled patients. We will likely give periodic safety updates as we receive the mass safety data. And that's what we have planned at the present time. Ramiro anything else you'd like to add about potential other masked interval additions?
Ramiro Ribeiro, Chief Medical Officer
No, I think you covered well. We are aware that there is always a potential risk of introducing bias if we disclose too much in a Phase III study, so we are evaluating that.
Operator, Operator
Our next question comes from Colleen Kusy from Baird.
Colleen Margaret Kusy, Analyst
Congrats on all the progress. If I can go back to the rescue criteria, can you talk about how the FDA views the rescue criteria and how they would handle the evaluation of the Phase III data for those patients that got rescued? And then separately on DME, any realized details are going to be forthcoming there, but any color you can share on the feedback from the FDA? And what are some of the factors you're still considering?
Jay S. Duker, President and CEO
Sure. So with respect to rescue criteria, the FDA, as far as I know, which only is limited to what we have been told and what we see publicly is they allow companies to apply their own standards for rescue criteria. And that's what we've done. Again, we were able to develop our rescue criteria based on real data. We did a large Phase II study, the DAVIO 2 trial, which not only informed us about the efficacy of our drug, but safety as well as statistics and really gave us good data on what really should be done with respect to rescues. DME, we were very pleased with the discussions with the agency. We are excited to start the pivotal program. And by start, I mean first patient enrolled in 2026. Technically, we've already started in the sense of preparing and manufacturing the inserts and obviously getting the clinical protocols ready. We're waiting for the written minutes. And after the written minutes in the fall, we will update publicly on what our plans are. One of the things going back to supplements, though I might add, is that supplements are not viewed as a treatment failure in our trial. The supplement patients have sensitivity analysis that will be applied to them, and that's according to the statistics package that we've worked out with the FDA. And that's consistent with the real world. Because in the real world, if you had a patient who required anti-VEGF injections, say, every four weeks, and you gave them a DURAVYU, and we're safe, tolerated, effective, FDA approved with a six-month label, yet they required one or two supplements over a year, that would be a tremendous value to the patient and the practitioner to go from 12 shots a year to four. So reflecting the fact that the idea of supplement because TKIs have a different MOA, supplementation in the real world is not necessarily a treatment failure. I think that's also reflected in how they will be handled in the pivotal trials.
Operator, Operator
Our next question comes from Graig Suvannavejh from Mizuho.
Unidentified Analyst, Analyst
This is Sam on for Greg. Congrats again on the quarter and all the progress. Maybe two quick ones for me. First, in terms of ASRS, just curious what the feedback has been from the physician community with their review. And then also for the upcoming presentation in September with the full end of study VERONA data, what incremental data should we be expecting compared to the top line?
Jay S. Duker, President and CEO
Thanks, Jim. We just got back from ASRS in Long Beach, and we had multiple meetings with advisory boards of various age groups and times in practice and a lot of one-on-one meetings. And I have to say, it was incredible. I mean, I was blushing. They were saying such positive things about our company and our program. Multiple investigators thanked us for allowing them to be in the program. And so it really was a kind of a nice segue from our announcement to full enrollment to the incredible positive feelings we had from all aspects of the retina community, not just about the execution of the trial and the ease of enrollment and the pleasure that they had being in it, but even the doctors who weren't in the trial starting to understand that, first of all, we're the next ones up with pivotal data in wet-AMD in about a year. So, we are the next ones up for both studies in about a year. So, they're excited about that. They're excited about the potential of a new mechanism of action, not just another anti-VEGF that may give another week or two of extension, but a true extension possible for six months or longer with a new MOA. So yes, it was a very, very productive, and I have to say, fun ASRS, and we really are looking forward, our entire team is looking forward to further interactions with the retina community and partnering with the retina community to really help their patients. As for what's coming in September, I'm going to defer to Ramiro for that update.
Ramiro Ribeiro, Chief Medical Officer
Yes, Sam, thanks for the question. I don't want to disclose so much because those presentations, retina society are important. But we're going to be building more on what we have presented before in terms of BCVA, CST and treatment burden for the VERONA trial.
Operator, Operator
Our next question comes from Daniil Gataulin from Chardan.
Daniil V. Gataulin, Analyst
Congrats on the progress. Just a couple of quick ones for me. With respect to LUCIA trial, what fraction of patients were U.S. versus ex U.S.? And with that experience of enrolling ex U.S. patients, how would you describe the awareness and overall interest among patients in ex U.S. compared to here in the United States?
Jay S. Duker, President and CEO
So I don't have the exact final numbers for, but the last I saw, it was approximately 80% U.S., 20% ex U.S. I think that reflects to a large degree, the fact that things went so fast in the United States that by the time we were able to get the ex-U.S. sites up and running, we, in some cases, were near the end of the study or at the end of the study. But the interest in a sustained release, safe, effective six-month option ex U.S. is really, really great. As you know, in some countries, getting long-term acute care, meaning monthly or bimonthly injections for a chronic problem is difficult. So both patients and practitioners were really excited about what DURAVYU might have to deliver should we be approved.
Operator, Operator
Our next question comes from Yi Chen from H.C. Wainwright.
Yi Chen, Analyst
Could you please let us know whether there will be another Data Safety Monitoring committee meeting before the first data readout in mid-2026? And also, how should we look at the level of top line revenue in the coming quarters?
Jay S. Duker, President and CEO
The first question about the DSMB, Ramiro, do you want to answer that?
Ramiro Ribeiro, Chief Medical Officer
Yes. So as a typical Phase III program, we have a DMC meeting every six months. So we expect to have at least two or more of those before the top line results.
Jay S. Duker, President and CEO
And the second question was about revenue? I'm sorry, you broke up a little bit.
George O. Elston, Executive Vice President and CFO
Yes. In the second quarter, we completed the follow-on revenue recognition related to our exit from the commercial business two years ago. This was not cash driven, and moving forward, our revenue from this area will be minimal. We still supply a commercial product to our partner in China, but we do not anticipate that contributing significantly to our revenue. As Jay mentioned at the beginning, we have truly transitioned into a clinical stage company.
Operator, Operator
Our next question comes from Greg Harrison from Scotiabank.
Joseph Stephen Thomas, Analyst
This is Joe Thomas on for Greg. Just digging a little bit more maybe into the competitive landscape going forward and particularly the timing to market now that the competitor has announced that they won't read out their second trial until 2027. What advantage do you think that first-mover advantage in being first to market will give to DURAVYU wet AMD?
Jay S. Duker, President and CEO
Joe, thanks for the question. Taking a step back, this is a huge market already. It's $10 billion and growing. And that if you look at drugs with a new MOA being launched into a new market, having two competitors actually is additive. So we think having other companies interested in TKIs and sustained delivery is a good thing. In saying that, the first-mover advantage is really important. And I think there's quite a bit of research around what the first mover advantage can be. But it's not just first mover. It's also ease of use and the label. We're confident that if we are approved, we will be approved with a label of every six months. And that flexibility to treat patients who may have recurred at seven months or eight months with fluid, again, at that point with your drug, I think, is going to be something that's going to be quite helpful to us. Our safety database from the Phase II is very strong. Our safety continues in a mass fashion to match that. So we also believe that we will come out compared to other potential competitors in the space with a probable safety advantage. So it's not just the first mover. I think there's a whole package of reasons why we are confident that we will be the leader in drug delivery sustained release in the retina should we be approved for many years.
Operator, Operator
I am showing no further questions at this time. Ladies and gentlemen, thank you for participating in today's conference. This does conclude your program. You may now disconnect. Everyone have a great day.