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 's Second Quarter 2025 Financial Results and Recent Corporate Developments Conference Call. There will be a question-and-answer session to follow the completion of the 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 EyePoint .
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 and 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 .
Thank you, George. Good morning, everyone, and thank you for joining us. I am delighted to discuss with you today our key second quarter updates, highlighted by the impressive progress of our phase III clinical program for our lead asset, DURAVYU, in wet age-related macular degeneration, or Wet AMD. Since January 2021, when the first patient was dosed with DURAVYU in our phase I DAVIO trial, our diligent focus and exceptional execution across all fronts have brought us, in just over four and a half years, to full enrollment in both of our phase III pivotal trials in Wet AMD, a testament to EyePoint 's leadership in drug development and commitment to serving the retinal physician community. Before discussing the specifics of the past quarter, I'd like to reflect on how far we've come as a company over this short period.
We successfully and efficiently pivoted to a clinical stage biopharmaceutical company, prioritizing the development of DURAVYU as a new treatment paradigm in the two largest retinal disease markets, Wet AMD and diabetic macular edema, or DME, while exiting the specialty pharma business. We completed four clinical trials for DURAVYU, including three phase II trials treating over 190 patients with DURAVYU across multiple retinal indications, establishing a robust and favorable safety profile that is cited by physicians as a key motivator for their eager participation in our pivotal program. We've generated the most comprehensive dataset among current sustained-release therapies in development for Wet AMD, establishing truly compelling phase II efficacy data demonstrating statistically non-inferior visual acuity compared to on-label aflibercept while reducing treatment burden by over 80%.
Bolstered by this robust efficacy profile, outstanding safety, and a patient-centric pivotal trial design, we completed oversubscribed phase III enrollment in record time for this indication, with over 800 patients enrolled across the LUGANO and LUCIA trials. Thanks to rapid enrollment and efficient trial design, we are well positioned for top-line LUGANO data in mid-2026, with LUCIA top-line data anticipated shortly thereafter, a timeline that we believe positions us to be first-to-file and potentially first-to-market among the current investigational sustained-release therapies for Wet AMD . We also expanded the database underpinning DURAVYU's differentiated clinical profile beyond Wet AMD, reporting highly positive results in the phase II VERONA trial in DME, supporting a pivotal program in this second blockbuster indication.
In anticipation of potential commercial success, we built a state-of-the-art 41,000 square foot CGMP manufacturing facility in Northbridge, Massachusetts, to support commercial production of DURAVYU, with registration batches currently underway to support an anticipated NDA filing and eventual pre-approval inspection. Finally, we transformed our balance sheet by eliminating debt and extending our cash runway into 2027, well beyond pivotal Wet AMD data in 2026. I am incredibly proud of the pace and quality of these achievements, and we have no intention of taking our foot off the gas. Now, for a closer look at Wet AMD, this is a $10 billion market and growing in the United States, currently dominated by a single treatment modality, monotherapy with anti-VEGF biologics. While efficacious, patients with Wet AMD still tend to lose vision in the long term.
Newer options, intended to provide up to four months of visual stabilization in some patients, still have similar limitations and often require significantly more frequent injections to maintain stable vision. In light of these drawbacks, improved durability remains the most important factor for physicians when choosing a Wet AMD therapy and represents an area of much-needed innovation. Our lead product candidate, DURAVYU, presents a compelling treatment paradigm shift paired with a new mechanism of action to meet this need. Backed by durable efficacy of at least six months and a consistent and favorable safety profile, coupled with unique storage and administration advantages, we believe DURAVYU offers a differentiated product profile that is meaningful to physicians and patients and, if approved, would facilitate strong competitive positioning in the Wet AMD treatment landscape. Let me now walk through the key attributes underpinning DURAVYU's differentiation.
First, DURAVYU is not another anti-VEGF biologic or ligand-blocking therapeutic like the approved products on the market. It's a clinically validated sustained-release tyrosine kinase inhibitor, or TKI, that brings a new mechanism of action that may complement existing anti-VEGF biologics to offer more durable disease control and a reduced treatment burden. DURAVYU is comprised of the potent and selective TKI vorolanib, which works intracellularly to inhibit all VEGF receptors as well as the PDGF receptor, formulated in our bioerodible Durasert E technology. Durasert E is a next-generation bioerodible sustained-release insert with a matrix designed to prevent free-floating drug particles that contains no PEG and no PLGA. Unlike other sustained delivery therapies in development, DURAVYU is shipped and stored at ambient temperature. Consistent with current practice, DURAVYU is administered in the physician's office with a standard intravitreal injection and comes in a preloaded sterile syringe injector.
Most importantly, through its novel mechanism of action, DURAVYU can potentially deliver stable vision and retinal anatomy when dosed every six months, a cadence that should support improved compliance over the long term for Wet AMD patients. The clinical data generated to date indicates that DURAVYU has the potential to meaningfully change the Wet AMD treatment paradigm, and we've designed our phase III program to validate this through a clinically rigorous but de-risked approach. Our phase III LUGANO and LUCIA trials are double-masked non-inferiority trials designed in close alignment with the FDA, including written agreement from the agency to support a clear approval pathway and a compelling label. In addition, the patient-centric design of the trials allows all patients to receive treatment with the goal of maintaining or improving vision. The trials leverage an established design to measure non-inferiority against on-label 2 milligram aflibercept.
The use of on-label standard of care as the control is a key component of FDA guidance and critical to the non-inferiority design of the trials. Retinal specialists are familiar with leveraging non-inferiority trial data to inform their prescribing decisions, as the last four Wet AMD approvals in the United States follow this approach. Furthermore, the inclusion of both treatment-naive and previously treated patients enhances the applicability of our data and can enable a potentially broader label that would help drive increased physician adoption. If approved, our label is expected to have a differentiated six-month dosing interval. This would be a significant improvement compared to current anti-VEGF treatments in the United States, which are dosed on average every two months.
Driven by the clear market need for more durable Wet AMD therapy, DURAVYU's patient-centric trial design, robust and compelling phase II clinical data package, and a record of excellent safety across the full clinical development program, we enrolled and randomized over 800 patients in LUGANO and LUCIA trials. LUCIA also marks our global expansion with sites in South America, Europe, Israel, Australia, and India, demonstrating continued momentum and demand across the global Wet AMD patient community for DURAVYU. We are proud of the clinical rigor of our phase III program, underscored by the fact that both the FDA and the EMA, the two largest regulatory agencies in the world, have signed off on the protocol, and we have exceeded our enrollment timelines with no major changes to our trial design.
With a 56-week primary endpoint for both trials, we anticipate LUGANO top-line data in mid-2026, with LUCIA to closely follow, giving us confidence in our first-to-file and first-to-market position among current investigational sustained-release therapies. The consistently positive feedback from physicians and patients continues to strengthen our conviction in DURAVYU's differentiated profile and eventual commercial success. As part of the efforts to maintain first-mover advantage, we have made significant strides in our commercial readiness while remaining disciplined in our investments. Our state-of-the-art CGMP commercial manufacturing facility in Northbridge, Massachusetts, is designed to meet future commercial demand. In support of a potential NDA filing, DURAVYU registration batches are underway. Additionally, we thoughtfully added to our organization, expanding key areas such as late-stage clinical development, regulatory, pharmacovigilance, biometrics, and medical affairs, all while maintaining fiscal discipline.
While our top priority is advancing our Wet AMD program through top-line data and an NDA filing, we are also excited to report our continued progress in DME, the second largest retinal disease indication. Affecting approximately 25% of diabetic patients, DME is estimated to represent a $3 billion market opportunity by 2030 in the United States. Like Wet AMD, the significant burden of regular anti-VEGF injections often results in missed doses and lost vision, suggesting the need for more durable therapies. Following the compelling safety and efficacy results of our phase II VERONA trial in DME earlier this year, we had a positive end-of-phase II meeting with the FDA to align on a future pivotal program. We look forward to sharing more details on our pivotal plan in the upcoming months.
In summary, with top-line phase III data for both LUGANO and LUCIA on track for readout in 2026 and urgent and growing need for safe, effective, and more durable treatment options for Wet AMD and DME, EyePoint is well positioned to continue as the leader in sustained-release drug delivery for retinal disease as we partner with the retinal physician community to improve patients' lives while creating long-term value. Our decades of clinical experience, next-generation technology, and blockbuster potential of the DURAVYU franchise highlight our exciting growth story. Before passing it over to George to review our financials, I want to thank the entire EyePoint team for their commitment to our goal of improving patients' lives through better vision, as well as the patients and the clinical investigators outside of our organization who are participating in our trials.
We deeply appreciate your confidence in us, and we are proud to advance our therapeutics for the benefit of the entire retinal community. We look forward to continued progress towards our upcoming milestones as we further our leadership in sustained ocular drug delivery. I will now turn the call back over to George. George?
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 30th, 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 boutique 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 non-operating 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 31st, 2024. 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.
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.
Thank you. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. As usual, we will try to get to as many questions as we can through the course of the call. Please limit your number of questions to one to give others a fair chance to participate. Please stand by while I compile the Q&A roster.
Our first question comes from Tess Romero from JPMorgan. Please go ahead.
Good morning, Jay and team. Thanks so much for taking our question. 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. Thank you.
Thank you 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's 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?
Yes. Thanks for the question, Tess. I think one advantage that EyePoint has is that we have a strong, large phase III study that gave us a lot of experience on the conduct of studies with our DURAVYU. As Jay mentioned, we executed really well on the enrollment, completed the enrollment for both studies ahead of time, and now the focus is on the study conduct. Of course, we have a collaboration very closely with the clinical sites, with the investigators, to get and make sure that there are no deviations on the protocol. We also, of course, track the safety of our patients in the study, which is very important. We have a good collaboration with our CRO that helps us conduct the study.
Now it's all about making sure that we have a great execution over the next 12 months and then start a preparation for our top-line results with on-time database lock and other activities that are necessary for the top-line results.
Thank you.
Maybe if I could add just a little bit more about our protocol. Once again, this non-inferiority 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. 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. From that regard, we're doing really, really well also.
Thank you.
Thank you. Our next question comes from Jennifer Kim from Cantor Fitzgerald. Please go ahead.
Hey, good morning. Thanks for taking my questions and congrats on the continued execution, the delivery, and consistency of these trials. It's been refreshing to see. Maybe to start off, I know you said you've talked about not disclosing certain mask data in the phase IIIs and avoiding introducing operational bias. Is there a line that would concern regulators in terms of introducing bias? 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.
Yeah, good question, Jennifer. Thanks for that. 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. While we may, under certain 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. Once again, Ramiro, if you want to give a little more color on that or any more detail, please feel free.
No, I think you covered it well. 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. We issued that press release and included that information that the safety of LUCIA and LUGANO is going as we expected, as well as our phase II study. As Jay mentioned, we want to make sure we don't introduce unnecessary bias in a study that is going so well so far.
Okay, that's helpful. 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?
I think we will give periodic updates. We haven't really discussed internally whether there will be a cadence. We'll cover that in the future. 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.
Okay, helpful. Thanks guys .
Thank you. Our next question comes from Tyler Van Buren from TD Cowen. Please go ahead.
Hey, thanks, and 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?
Thank you for the question, Tyler. I'll actually address the second part of your question first. If you talk to retina specialists and you ask them about the supplemental criteria in anyone's study, their first reaction is, "Well, that's not what I do in the real world." 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's the other eye doing? Do they notice a change? A myriad of things that individualize treatment for patients. For a study, you can't do that. You need to have strict guidelines, especially in a pivotal program, about when a rescue or supplement injection is given. 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. 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. We've set up a system that's working, we think, quite well with injection monitors. 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. 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.
When we looked at the fundus photographs and the clinical situation with our KOLs and our advisors, 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. 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. Therefore, this was Dr. Ribeiro's evaluation of the rescues in the phase II. We don't have a criteria for fluid alone. We don't have a criteria for visual acuity loss alone because in those situations, what we saw in the phase II as a rescue injection didn't help. In the phase II, 20% of the rescues were not per any of the protocol rescue requirements. They were due to the physician discretion. We've removed physician discretion in the phase III.
Thank you. Our next question comes from Yigal Nochomovitz. Please go ahead. Yigal? One moment. Our next question comes from Yatin Suneja from Guggenheim. Please go ahead.
Hey, guys. Thank you for taking my question. Maybe two quick ones from me. With regard to the baseline, could you just comment on what % of naive and exposed patients you are targeting and where did you end up? If you can just talk about that on a high level. Switching to the commercial dynamic, could you just talk about your early commercialization strategy, what work you might be doing now, what type of patients can be addressed, and how should we think about the overall commercial team? Yeah, thank you.
Awesome. Thanks, Yatin. Nice to hear from you. First of all, with the baseline division between patients who were previously treated and who were naive to treatment, we sought to get about a 75%/25% naive- to- previously- treated ratio, and that's, in fact, what we achieved. So 75% of the enrolled eyes were naive. With respect to commercialization, we've had an early product commercialization team on this essentially since the beginning of our phase II DAVIO 2 Wet AMD trial. They had been working diligently, not only in, let's say, preparing the market, which I think they've done a very good job in raising physician awareness of what a TKI is and how it's differentiated from our current therapies, as well as how a sustained-release delivery system like Durasert E can be advantageous for small molecule delivery.
They've also been in discussions with payers and with administrators of both large and small retinal practices in the United States and out of the United States to get a feel for how we can set the stage for us to be successful in the marketplace. This has been an extensive, broad, and deep effort that we've done and will continue to do. We are planned and budgeted to start to build our commercial team in more breadth and depth later this year in anticipation of a successful NDA and potential launch, we hope, at the end of 2027.
Maybe one more if I can follow up. Just on the naive versus exposed patient, is there a special consideration for how we should think about the rescue rate or the injection fee rate, at least on the control arm for these naive versus the exposed patient? Just curious to know how that dynamic would be between these two subsets.
That's a good question, Yatin. I don't think we can actually know that yet. We expect that the rescue rate for naive patients will be less than what we saw in the DAVIO 2 phase II trial. The reasoning is in the DAVIO 2 trial, while they were all previously treated patients, the vast majority of them were being treated often, as we like to refer to them as frequent flyers. On average, those patients had received 10 injections normalized over the year leading into the study. In the United States , we retina specialists average about six injections per year. This was a group of patients that needed a lot of treatment, yet we did pretty well with them. We got very few patients who had already been treating extended out three months or longer. They just didn't enroll in that trial.
Our assumption, and I think it should be clear to everybody, is that if we have a patient who can be successfully treating extended out to three months or longer on any of the current agents, our drug, DURAVYU, should do really well with those patients. We wanted to get a portion of them into the trial. Depending on who you talk to, this could be 20% or 25% of the Wet AMD naive population. We think that by enrolling a predominantly naive population, we should see fewer supplements, and we hope to see, therefore, better visual acuity results. I will like to remind everyone that if you looked at the patients in DAVIO 2 that did not get supplemented, they made it through month eight with no supplement, their visual acuities were numerically better than the Eylea control group.
The unsupplemented patients seem to do exceptionally well with our drug, and we hope and expect that will continue in the pivotal trial.
Thank you. Our next question comes from Yigal Nochomovitz from Citigroup. Please go ahead.
Hi, great. Thanks. 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. 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? Also, just looking ahead to the potential launch, assuming everything goes well with the studies, is this a situation where once you get the label, you can just launch immediately, or is it a situation where you would wait till 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? Thanks.
Great, great. Thanks, Yigal. Two good questions. 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. 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. 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.
Overall, the agency strongly suggested it, and we did it, and we're very happy that we did it. We think this is another point of our protocol that is de-risking. In addition, I have to add the blended endpoint has been used in most recent studies. This isn't new or unique. 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.
Great, thank you very much.
Thank you. Our next question comes from Dibanjana Chatterjee. Please go ahead.
Hi. Thanks for taking my question. With the first readout expected in mid-2026 and the second to follow shortly after, could you give us any more color into your regulatory plans on how you'll gather the data and how soon you can submit? Maybe could you also comment on the scope of the safety package that the FDA would like to see with the initial filing?
Sure. Thank you for that question. 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. We expect top-line data from the first trial to be summer of next year, with the second trial to follow shortly. I'm going to let Ramiro talk about some of the efforts around rapid NDA filing that we are working on.
Yeah, thanks for the question. As Jay mentioned before, our expertise and our strength is on the execution. 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. 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, we should assume that the result of LUGANO is going to be replicated on LUCIA. In terms of the safety package, as any other NDA submission, this is going to include the results from our phase I, phase II study, as well as the combination of the phase III program.
We should have enough patients to meet the requirements for the FDA for this type of indication.
I'm sorry. I want to elaborate a little bit more on what Ramiro just said about numbers. The FDA has been clear for years about Wet AMD safety database. You need to have 300 evaluable patients at the dose and the interval that you want on your label. If you come in with 299, it will not be accepted. If you look at the draft guidelines, the draft guidelines say you need—we recommend 400 patients enrolled in your trials at the dose and the interval you want to go to market with. That is to allow for attrition, so you come in with over 300. We will have well over 400 patients between both trials at the six-month dosing, at the six-month interval at the 2.7 milligram dosing. We are very comfortable with the safety database that we will be coming in with.
I will also remind you, we can file after one year, 56 weeks, but both trials will have a second year, which is a safety year only. We will file an SNDA for the extension after the second year. Go ahead if you had another—
Yes, just a very quick one on filing. Could you please remind us what would be the advantage of filing the traditional way versus the 505(b)(2) pathway that some competitor trials like they are talking about? While the traditional one might be slightly longer, are there distinct advantages that you get there?
My understanding is that if you are filing with a drug that's been approved already, there is a potential two-month savings over the traditional pathway. As you're aware, the FDA has talked publicly recently about accelerating the pathway in various ways. We will obviously be looking at those for our filing. Regardless, if you have a moiety that's already been approved, but you're putting it now into a drug-device combo, there are rules around what you need to file with for drug-device combo. We all have the same necessary clinical studies and CMC package that has to be delivered. There's a short potential savings there. We are quite confident, given the rapid rate of enrollment that we've had, that we will be first to file. If the filing is accepted, first to approval and first to launch among all the currently studied sustained-release in the marketplace or potential marketplace, rather.
Very helpful. Thank you.
Thank you. Our next question comes from Lisa Walter from RBC. Please go ahead.
Oh, great. Thanks so much for taking our questions. 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? Also, just curious if you are planning to run an open-label extension study for DURAVYU. Thanks so much.
Thanks for the questions. The second one's 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. That is in planning. As for pivotal trial progress, 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. That's what we have planned at the present time. Ramiro, anything else you'd like to add about potential other masked interval additions?
I think you covered well. We know the always the potential risk of introducing bias if you start disclosing too much in a phase III study. We are always assessing that one.
Thank you. Our next question comes from Colleen Kusy from Baird. Please go ahead.
Great. Good morning. Thanks for taking our questions and 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? Separately on DME, any real 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? Thank you.
Sure. 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, allows companies to apply their own standards for rescue criteria. That's what we've done. 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, I might add, is that supplements are not viewed as a treatment failure in our trial. The supplementations 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. 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 4.
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.
Helpful. Thank you.
Thank you. Our next question comes from Greg Silvanouve from Mizuho . Please go ahead.
Hi. This is Sam on for Greg, thanks for taking our questions and congrats again on the quarter and all the progress. Maybe two quick ones from me. First, in terms of ASRS, just curious what the feedback has been from the physician community with DURAVYU. 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? Thank you.
Thanks, Sam. 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. 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. It really was a kind of 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.
We're the next ones up for both studies in about a year. They're excited about that, and 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. 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.
Yes, Sam, thanks for the question. I don't want to disclose so much because, you know, those presentations in the Retina Society are important. We're going to be building more on what we have presented before in terms of BCVA, CST, and 3GM burden for the VERONA trial.
That's helpful. Thank you.
Thank you. Our next question comes from Daniil Gataulin from Chardan. Please go ahead.
Yes. Hi. Good morning, guys. Thank you for taking the question and congrats on the progress. Just a couple of quick ones from me. With respect to LUCIA trial, what fraction of patients were U.S. versus ex-U.S.? 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? Thank you.
I don't have the exact final numbers for LUCIA, 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. 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 bi-monthly injections for a chronic problem, is difficult. Both patients and practitioners were really excited about what DURAVYU might have to deliver should we be approved.
Thank you. Our next question comes from [audio distortion] from H.C. Wainwright. Please go ahead.
Thank you for taking my question. Could you please let us know whether there will be another data safety monitoring meeting before the first data readout in mid-2026? Also, how should we look at the level of top-line revenue in the coming quarters?
The first question about the DSMB, Ramiro, do you want to answer that?
Yes. As a typical phase III program, we have a DMC meeting every six months. We expect to have at least two or more of those before the top-line results.
The second question was about revenue? I'm sorry. You broke up a little bit.
Yes, yes. The level of top-line revenue that you expect for the coming quarters.
George? Top-line revenue.
Yeah. You'll see in the Q, recall that we exited the commercial business two years ago. We had some follow-on revenue recognition really associated with that. It wasn't cash-driven, and that was completed in Q2. Moving forward, our revenue line will be de minimis. We still supply commercial product to our partner in China, but we don't expect that to be a material number. We've really transitioned, as Jay said at the opening, to being a clinical stage company. Got it. Thank you.
Thank you. Our next question comes from Greg Harrison from Scotiabank. Please go ahead.
Hi, everybody. Thank you for taking the question. 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?
Joe, thanks for the question. Taking a step back, this is a huge market already. It's $10 billion and growing. If you look at drugs with a new MOA being launched into a new market, having two competitors actually is additive. We think having other companies interested in TKIs and sustained delivery is a good thing. The first-mover advantage is really important. I think there's quite a bit of research around what the first-mover advantage can be. 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. 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, very strong. Our safety continues in a mass fashion to match that. We also believe that we will come out compared to other potential competitors in this space with a probable safety advantage. 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.
Great. Thank you so much.
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.