OCGN

LLM Evaluations

Transcript Summary

Ocugen, Inc. (OCGN) reported strong 2025 results, headlined by the completion of enrollment for its OCU400 Phase 3 Limelight trial in retinitis pigmentosa. The company’s modifier gene therapy platform distinguishes itself through a gene-agnostic approach, potentially treating 99% of RP patients. A rolling BLA submission is planned for 2026, with potential approval in 2027. OCU410 for geographic atrophy and OCU410ST for Stargardt disease also showed significant progress; OCU410 demonstrated a 46% reduction in lesion growth in Phase 2, while OCU410ST data supported its potential to protect photoreceptor integrity. Management highlighted the "one-and-done" nature of these therapies as a key differentiator against current competitors requiring frequent injections. Financially, a $22.5 million raise and potential warrant exercises provide a cash runway into 2027. New leadership appointments in finance and operations aim to support the transition to a commercial-stage enterprise. During the analyst call, management defended its proprietary mobility endpoints and emphasized the clinical relevance of ellipsoid zone (EZ) measurements as a predictor of functional benefit. With three BLA filings targeted over the next three years, Ocugen maintains a bullish outlook on its ability to address massive unmet needs in the ophthalmology market.

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Full Earnings Call Transcript — Q4 • 2026-03-04

Operator: Good morning, and welcome to Ocugen, Inc.'s Fourth Quarter and Full Year 2025 Financial Results and Business Update. All participant lines are currently in listen-only mode. Following the speakers' commentary, there will be a question-and-answer session. I will now turn the call over to Tiffany Hamilton, Ocugen, Inc.'s Head of Corporate Communications. You may begin.
Tiffany Hamilton: Thank you, Operator, and good morning, everyone. Joining me on today's call and webcast is Dr. Shankar Musunuri, Ocugen, Inc.'s Chairman, CEO, and Co-Founder, who will provide a business update and an overview of our clinical and operational progress. Rita Johnson Green, our Chief Financial Officer, is also on the call to provide a financial update for the quarter and full year ended 12/31/2025. Dr. Huma Qamar, Chief Medical Officer, will be available to answer questions following the presentation. This morning, we issued a press release detailing associated business and operational highlights for the fourth quarter and full year 2025. We encourage listeners to review the press release, which is available on our website at ocugen.com. A replay of this call, along with the accompanying slide presentation, will be available on the Investors section of the Ocugen, Inc. website at investors.ocugen.com. Before we begin, please note that certain statements made during today's discussion may be forward-looking in nature, including those related to our clinical development pipeline, regulatory timelines, commercialization strategy, and financial information and our anticipated cash runway. These statements reflect management's current expectations and are inherently subject to risks, uncertainties, and assumptions that may cause actual outcomes to differ materially from those expressed or implied. We encourage you to review our filings with the Securities and Exchange Commission, including the risk factors detailed therein, for a more comprehensive understanding of these potential risks. Finally, Ocugen, Inc.'s Annual Report on Form 10-K covering the full year 2025 will be filed today. I will now turn the call over to Dr. Musunuri.
Shankar Musunuri: Thank you, Tiffany. And thank you all for joining us today. I am pleased to share an update on what was a transformative year for Ocugen, Inc. Considerable development across all of our modifier gene therapy programs, including licensing and financing agreements to strengthen our financial position and meaningful appointments to our leadership team, made 2025 a year of real momentum for Ocugen, Inc. We are now poised to leverage upcoming catalysts and advance the business as we near the first half of our three BLA filings. I am proud of what this team has accomplished, and I am confident that with the full range of experience in retinitis pigmentosa, which I will refer to as RP going forward. It is important to note that the Phase 3 Limelight clinical trial is the only broad RP gene-agnostic trial, and the largest known Phase 3 orphan gene therapy trial. Approximately 300,000 people in the U.S. and Europe are living with RP, which is caused by mutations in more than 100 genes. OCU400 is designed as a modifier gene therapy utilizing NR2E3, a central transcriptional regulator of retina-specific pathways, to address multiple genetic mutations with a single one-time treatment. The only approved gene therapy approach for RP today targets a single gene, RPE65, which accounts for just 1% to 2% of the total RP patient population. We believe OCU400 has significantly wider commercial potential, as it is intended to provide a therapeutic option for 98% to 99% of all RP patients. I am pleased to report that enrollment is now complete for the OCU400 Phase 3 Limelight trial. As a one-year clinical trial, top-line data will be available in 2027. These data are anticipated to support the Biologics License Application (BLA) filing for OCU400 and potential approval in 2027. The Limelight clinical trial enrolled 140 patients who were randomized 2:1 into the treatment group and untreated control group across mutations, including RHO, and gene-agnostic arms. The gene-agnostic arm includes many genetic mutations, including those most prevalent: USH2A, XLRP, and PDE6B. The target population included patients with early- to late-stage disease among a broad RP population, including pediatrics. The primary endpoint is 12-month change in visual function assessed by LDNA (luminance-dependent navigation assessment), with improvement in lux level from baseline to 12 months. We also released positive long-term three-year Phase 1/2 data for OCU400 that build on our prior two-year results. The data demonstrate a sustained, clinically meaningful approximately two-line LLVA gain, reinforcing durable gene-agnostic benefit. OCU400 maintained a favorable durability, safety, and tolerability profile, with no new treatment-related serious adverse events or adverse events of interest emerging. With enrollment complete and these strong long-term data in hand, we are on track to begin the rolling BLA submission in 2026. Process validation and manufacturing activities are progressing well in support of the timeline, and planning and marketing initiatives are scaling up as well. We anticipate commercialization in 2027 in line with our commitments. As we prepare for what will ultimately be the global rollout of OCU400, we are pursuing regional partnerships that preserve Ocugen, Inc.'s rights to larger geographies while also generating near-term value for our shareholders. In 2025, we executed our first regional licensing agreement with QuanDan Pharmaceutical Company Limited for the exclusive Korean rights to OCU400. With upfront fees and near-term development milestone payments along with royalties, this was a valuable collaboration for Ocugen, Inc. and a critical step in the company's business development strategy. There are an estimated 7,000 individuals in the Republic of Korea with RP, equal to approximately 7% of the addressable U.S. RP market. This approach allows us to maximize total patient reach while retaining full commercial rights in the U.S. and Europe. Now let us move on to OCU410ST for Stargardt disease. OCU410ST holds the potential to target over 1,200 pathogenic mutations in the ABCA4 gene associated with Stargardt disease and other ABCA4-related retinopathies with a single one-time treatment. Stargardt disease affects approximately 100,000 patients in the U.S. and Europe combined, and approximately 1,000,000 people globally, with no approved treatment options available. The Phase 2/3 Guardian-3 pivotal confirmatory trial remains ahead of schedule. We anticipate top-line Phase 2/3 data in 2027, followed by the BLA submission. In January, we announced the peer-reviewed publication of our Phase 1 Guardian trial results in Nature Eye, which supports a favorable safety, tolerability, and efficacy profile of OCU410ST and its potential to provide clinically meaningful functional and structural benefits in Stargardt patients. This independent validation further strengthens the scientific foundation supporting the ongoing pivotal trial. Importantly, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency confirmed that data from our single U.S.-based trial can also support an EMA application. This alignment allows us to maintain the same timeline and budget efficiencies in Europe as we have with the OCU400 hurdle trial, streamlining our development efforts and bringing OCU410ST to patients in Europe sooner than originally anticipated. The program has also received Rare Pediatric Disease designation, further strengthening its regulatory positioning. I would like to explain ellipsoid zone (EZ) analysis in greater detail, as this is now an exploratory endpoint for both the Guardian-3 and ARMADA clinical trials. The ellipsoid zone is a hyperreflective band representing photoreceptor inner and outer layer segmentation. It indicates photoreceptor health and is a biomarker for photoreceptor structural integrity and metabolic health. EZ disruption precedes RPE loss and visible atrophy in geographic atrophy and Stargardt disease. EZ measurement is important because it provides early and sensitive detection. EZ changes occur before visible RPE atrophy expansion in GA and Stargardt progression. It also enables earlier intervention and more sensitive treatment effect detection in GA and Stargardt. Finally, EZ correlates to earlier functional therapeutic benefit, with an effect as early as one year compared to other measures such as visual acuity, with clinically meaningful effect at two years or more. Since all of our clinical trials aim to demonstrate benefit at one year, and we are targeting significant unmet medical needs, EZ is a relevant measure to show functional outcome in these trials. As EZ analysis has been established as a clinically relevant endpoint for dry AMD clinical trials, it was critical to incorporate this measure for both our Stargardt and GA trials. As shown in this bar graph, change from baseline at 12 months in treated fellow eyes across doses, excluding two subjects lost to follow-up and one subject with retinal detachment, demonstrated a mean of approximately 16% in lesion reduction in available treated eyes relative to untreated eyes. Specifically, 50% of OCU410ST-treated eyes achieved EZ preservation exceeding expected disease decline or atrophy progression at 12 months. This change-from-baseline structural preservation on spectral-domain OCT, quantified as approximately 16% lesion reduction in ellipsoid zone integrity, highlights meaningful photoreceptor protection and functional therapeutic benefit in Stargardt disease, underscoring the key differentiator of modifier gene therapy. Now let us turn to OCU410 in GA secondary to late-stage dry AMD. With approximately 2 million to 3 million GA patients in the U.S. and Europe combined, OCU410 represents a significant market opportunity. OCU410 is specifically designed to address multiple pathways implicated in the pathogenesis of dry age-related macular degeneration and offers a promising advantage over current treatment options that target only one pathway, the complement system. Currently approved treatment options require frequent intravitreal injections, about 6 to 12 doses per year, and are accompanied by various safety risks. For example, roughly 12% of patients develop wet AMD following treatment. There are no treatments approved for GA in Europe, and existing FDA-approved options have failed to demonstrate meaningful functional outcomes. OCU410 is therefore well-positioned to address this critical unmet need. In January, we announced positive preliminary 12-month data from approximately 50% of patients evaluated to date in the Phase 2 ARMADA clinical trial evaluating OCU410. The key findings were compelling. We observed a 46% reduction in lesion growth at 12 months across the medium- and high-dose groups combined versus control, with statistical significance at p = 0.015 in a cohort of 23 patients. We also saw a 50% responder rate, with patients achieving greater than 50% lesion size reduction versus control. To put this in context, currently marketed products have demonstrated only a 22% lesion reduction in two years. So at one year, OCU410 is already delivering more than double the benefit seen with existing therapies in twice the time. A subgroup analysis of patients with baseline lesion size of 7.5 mm² or greater, representing advanced atrophy, demonstrated a 57% reduction in lesion growth for the medium dose and a 56% reduction for the high dose compared with control. This suggests OCU410 may be even more effective in patients with substantial disease burden. The dataset also included encouraging 12-month Phase 1 findings, where OCU410-treated eyes demonstrated 60% slower loss of the ellipsoid zone, or EZ, compared to untreated fellow eyes. The 60% reduction in EZ loss rate indicates that OCU410 treatment is substantially slowing the rate of photoreceptor degeneration compared to the natural history observed in the untreated fellow eyes. We look forward to reporting the complete dataset from the OCU410 Phase 2 ARMADA trial this month and anticipate initiating Phase 3 in 2026. Let me also provide a brief update on our other programs. For OCU200, no serious adverse events or adverse events related to OCU200 have been reported to date across the Phase 1 dose-escalation cohorts, and trial enrollment is expected to be completed in 2026. Regarding our enhanced vaccine candidate, OCU500, NIAID intends to initiate the Phase 1 clinical trial in 2026. Finally, we created Arthroselix as a wholly owned subsidiary for our regenerative cell therapy assets, including NeoCart, with the goal to be independent through financing that will maximize value for Ocugen, Inc. shareholders and patients. We will provide further details as the process progresses. Across the portfolio, 2026 represents multiple defined inflection points. These include completion of enrollment for OCU410ST in early 2026, full Phase 2 data for OCU410 this month, interim pivotal data for OCU410ST in the third quarter, initiation of Phase 3 for OCU410 in 2026, and start of rolling BLA submission for OCU400 in the third quarter. Each of these milestones builds towards longer-term regulatory and commercialization objectives, and reinforces our commitment to file three BLAs in the next three years. Operationally, we also strengthened our executive leadership team with several appointments, including Abhi Gupta to Executive Vice President, Commercial and Business Development, bringing more than 20 years of experience across commercial strategy, gene therapy, and corporate development in the biopharmaceutical industry. Recently, Rita Johnson Green was named Chief Financial Officer. Rita's experience in financial strategy and capital planning supports our continued focus on disciplined resource allocation as our programs advance toward late-stage development and potential commercialization. And just this week, Paul Halsted joined us as Executive Vice President, Operations. Paul has more than 20 years of leadership experience in biologics and cell and gene therapy technical operations. He joins from Bristol Myers Squibb where, for over 16 years, he held leadership roles in manufacturing, launch, scale-up, and orchestration of reliable global supply chains, with a CAR T focus for the last five years. He will lead operations to strengthen execution and support the company's transition toward regulatory approvals and commercialization. I will now turn the call over to Rita Johnson Green to provide an update on our financial results for the quarter and full year ended 12/31/2025. Rita?
Rita Johnson Green: Thank you, Shankar. I am thrilled to join the Ocugen, Inc. team and support the company through its imminent transition into a commercial enterprise. Starting with our fourth quarter results, research and development expenses for the three months ended 12/31/2025 were $10,700,000 compared to $8,300,000 for the three months ended 12/31/2024. General and administrative expenses for the three months ended 12/31/2025 were $6,100,000 compared to $6,300,000 for the three months ended 12/31/2024. Ocugen, Inc. reported a $0.06 net loss per common share for the three months ended 12/31/2025 compared to a $0.50 net loss per common share for the three months ended 12/31/2024. For the full year ended 12/31/2025, research and development expenses were $39,800,000 compared to $32,100,000 for the full year ended 12/31/2024. General and administrative expenses were $27,600,000 compared to $26,700,000 for the prior year. Ocugen, Inc. reported a $0.23 net loss per common share for the year ended 12/31/2025 compared to a $0.20 net loss per common share for the year ended 12/31/2024. Our current cash and cash equivalents extend our runway into 2026. This includes the recent raise of $22,500,000 through an underwritten registered direct offering of common stock led by RTW Investments. In addition, if the $30,000,000 in warrants from the prior Janus Henderson raise are exercised in full, it will extend cash runway into 2027. That concludes my financial update. Shankar, back to you.
Shankar Musunuri: Thank you, Rita. We will now open for questions. Operator?
Operator: If you would like to ask a question, please press star and the number 1 on your telephone keypad to raise your hand and enter the queue. If you would like to withdraw your question or your question has been answered, please press star and the number 1 again. We will take our first question from Michael Okunewitch from Maxim Group. Please go ahead.
Michael Okunewitch: Hey, guys. Thank you so much for taking my question today. Congrats on all the great progress you have made. I guess to start off, given it is a 12-month primary endpoint for the Limelight study, how confident are you in the ability to turn around the data from when you hit on that top-line endpoint to actually releasing the top-line data within first quarter 2027?
Shankar Musunuri: Thank you for the question. We are very confident that we will be able to hit our timeline.
Michael Okunewitch: Alright. And then just for that endpoint, could you remind us of some of the modifications that you made for that particular navigation assessment course and why you decided to go with it as a primary metric for RP?
Huma Qamar: In terms of the mobility test that we are using, proprietary to Ocugen, Inc., that is luminance-dependent navigation assessment (LDNA). It is the mobility test that was approved as the primary endpoint for Luxturna; that was called MLMT at that time. That was only designed for RPE65 mutation that covers only 1% to 2% of the RP landscape. This is a very sensitive and specific test. As you can see, this is the broad RP indication trial, covering all clinical syndromic, nonsyndromic, all the genetic mutations that cause RP are included. So this has uniform lux levels and intensity and lux levels from 0 to 9, and that has the ability to capture the change in real time, which is from the baseline up to 52 weeks. This was also aligned with FDA, a validated test, as well as this was approved by FDA, and the only test that can capture the real change with functional outcome, demonstrating the functional outcome in these mutations. We are the only trial globally that is covering the majority of the gene-agnostic mutations as we have covered this morning in one of our slides as well. Thank you.
Michael Okunewitch: Thank you. That is certainly very helpful. And then last one before I jump back into the queue. For the Stargardt program, it is looking like there could be an approval from another company for a chronic therapy by the time you file for OCU410ST. So I wanted to know how this might impact the opportunity or pricing potential and if there is any reason that OCU410ST could not be complementary with other therapies as they come to market.
Shankar Musunuri: I will take that. There are other therapies out there. Obviously, what we have shown—if you look at the data we published in Eye—in one year, again, I want to restate all our trials were able to show treatment benefit in one year, unlike other trials out there of two years or more. The data we showed in one year are compelling. It looks superior. Our goal is to show functional benefit. With the gene therapy, we are targeting the major pathways, which are complex in Stargardt and GA. With our modifier gene, we also have the ability to reset the homeostasis and create a healthy environment for retinal cells to survive. That is very important. We are not just trying to slow down the disease progression. Our genes have the ability to control the internal network, so there is a big difference. Also, this is one-and-done. If you have a one-and-done therapy, this will set the standard of care. We are not worried about other therapies if they come to the market first. It is good—those therapies will educate the market and create market education. We may be behind them, but it is okay, because we believe we are going to set the standard of care for Stargardt patients globally. Huma?
Huma Qamar: Yes, I would like to add that this is the trial that we are also having the population three years of age and above versus the other trials that are very limited in the age population. Also, the inclusion/exclusion criteria are very globally representative. Other than that, OCU410ST is targeting early to advanced cases of Stargardt disease. If you look at the comparison, the safety, tolerability, and efficacy that we have seen in terms of lesion growth reduction and also the functional and structural outcomes have been trending in the right direction and are promising from the clinical standpoint as well.
Michael Okunewitch: Thank you. It is certainly an exciting time for the space. I am looking forward to any further updates that you have.
Huma Qamar: Thank you.
Operator: Thank you. Our next question comes from the line of Boris Peaker from TD Cowen. Please go ahead.
Shankar Musunuri: Boris? Mr. Peaker, you might be on mute.
Boris Peaker: Apologies—just came off mute. So for the RP OCU400 rolling BLA, when would we get the FDA feedback on your CMC part of the filing?
Shankar Musunuri: Typically, the CMC will be filed this year. Obviously, FDA has the right to request comments before, or they will wait for the entire BLA to be filed. Even though they are internally reviewing, you may not expect anything before the actual final clinical module is filed.
Boris Peaker: Got it. And, speaking of the FDA, have you discussed the ellipsoid zone as an endpoint with the Agency? I am just curious what their thoughts are about it as maybe a secondary endpoint. Is it something that could be incorporated into a label claim? Would that make any kind of a difference from the commercial perspective? Just general thoughts on that endpoint.
Shankar Musunuri: Ellipsoid zone—obviously, as we stated before, in all our clinical trials we are trying to show benefit because the diseases we are targeting have significant unmet medical needs. More delays and doing longer trials will take not only the resources from our perspective; it is not doing benefit to the patients. If you are able to show a benefit using primary endpoints we picked, which are acceptable, the EZ will be a secondary and some other analyses just to further support that we are demonstrating a good functional outcome or related to functional outcome. That is important. If you do longer trials, like two or three years, sure, we can look into multiple options. From FDA's perspective, they really focus on the primary endpoint. If you hit the primary endpoint, you will get the approval. If you hit the secondary, yes, you can include it in the product insert and the label. However, remember, in all our clinical trials, we have an obligation to continue them for five years for safety monitoring. That means one-year data are needed for filing. After that—second year, third year, fourth year, fifth year—we monitor the patients. We will continue to monitor them with these secondary endpoints. At any point the data are supportive, we can always add it to the label. From FDA's perspective, you have to hit the primary endpoint to get the product approved. Secondary is not necessary for approval. If you hit it, it is good; you can put it in the label.
Boris Peaker: Got it. But I just want to understand also, have you spoken to docs—what is the commercial value? Let us say you could get an ellipsoid zone label claim—not the primary endpoint, but still mention this positive in the label. Would that really make a difference? Is this something that the docs actually care about, or is it just kind of scientifically nice and it raises curiosity more than anything else?
Huma Qamar: Boris, this is Huma. So in terms of your question, with FDA alignment, yes, all the protocols are approved with exploratory secondary endpoints. In terms of EZ, it is the new hot topic for the clinicians in terms of functional outcomes and structural integrity for photoreceptors and retinal pigment epithelium. This is where FDA is leaning a lot based on these particular conditions such as Stargardt disease and geographic atrophy secondary to age-related macular degeneration. In fact, there has been buy-in and consensus from the IRD physicians as well as the geographic atrophy AMD surgeons as well. There is a real benefit to it, not only from the structural perspective but also from functional. This is now being taken not only nationally in the U.S., but also in Europe as well. Of course, there is clinical meaningfulness in terms of functional outcome for EZ. That is what we are seeing that could have potential meaning when we are going to file our claim commercially.
Shankar Musunuri: Also, for geographic atrophy, Phase 3 has not started. That is why we are going to look at the entire Phase 2 dataset this month, and then we are going to propose the endpoints with FDA and EMA. We do have an opportunity to introduce EZ as a secondary endpoint if the data are trending the way we anticipate.
Michael Okunewitch: Great. Thank you very much for taking my questions.
Shankar Musunuri: Thank you.
Huma Qamar: Thank you.
Operator: Our next question comes from the line of Swayampakula Ramakanth from H.C. Wainwright. Please go ahead.
Swayampakula Ramakanth: Thank you. Good morning, Shankar, Rita, and Huma. A couple of questions from me. Looking into the OCU410 program, in the Phase 2 study, the medium dose showed a 54% reduction versus the high dose, which showed a 36% reduction. I am trying to understand, as you go into your Phase 3 study, what is going to impact your decision for dose selection? Also, do you think that between these doses you are actually seeing some sort of a plateau effect in the transgene expression?
Shankar Musunuri: Good morning. The data we released—obviously, the high dose had fewer numbers in there. I would wait until we get the complete dataset this month to make an inference. From the Agency's perspective, if the lower dose is showing equal or better effect, you would take that into Phase 3. That is standard practice. I suggest we wait. Typically, for our genes—and what we have seen in our RP studies too—these genes require a threshold. Once you hit the threshold, we did not see any dose response. We are going to evaluate carefully once we get the full dataset.
Swayampakula Ramakanth: Thanks for that. In the subpopulation where the baseline lesions were greater than or equal to 7.5 mm², you saw a 57% reduction in lesion growth. As you get into the Phase 3 study, would you have any restrictions in terms of the size of the lesions, or do you plan to use the same criteria as in Phase 2, which was all comers?
Shankar Musunuri: That is a good question. This is why we do Phase 2. We are going to carefully evaluate. We go from 2.5 to 22 mm², and we are going to evaluate and see. On the lower side, as you know, analytically, you will have more variability. Of course, we are going to look at where the average patients fall, even though in the larger trials people have done with a lot of data. We are going to look at all those metrics and see what is the right group to go into Phase 3.
Swayampakula Ramakanth: Alright. The last question from me is on the OCU410ST program, where you are expecting to get the enrollment done this quarter and put up some interim data in Q3. In that dataset, what are we really looking for which can give us some indication of how the 2027 BLA filing is going to go, especially signals on either the structural side of things or on the functional side of things? What do you weigh more, and how should we be thinking when the data come out?
Huma Qamar: In terms of the masked interim analysis that is coming later part of the year, it will be for 24 subjects—16 treatment and 8 in the control. This is the adaptive design; that is a unique approach we have taken. The data points we are going to present, as we have presented this morning as well, are the primary endpoint—the lesion growth reduction—as well as structural and functional outcomes, which include visual acuity. We are also looking into the ellipsoid zone, which is the functional outcome that is very unique, and that data were very well received from the Stargardt perspective that we recently presented at one of the conferences as well. We are going to look at all of that, and, of course, safety and tolerability will be there as well. As of right now, it is trending in the right direction. This is what we are looking to release as masked interim analysis for those subjects later part of the year.
Swayampakula Ramakanth: Perfect. Thank you very much. Thanks for taking all my questions.
Operator: Our next question comes from the line of Elemer Piros from EF Hutton. Please go ahead.
Elemer Piros: Good morning. I would like to ask a question about the primary measure of visual function in the RP study. What would be a clinically meaningful improvement? Where do you draw the threshold toward that?
Huma Qamar: Thanks for your question. As we said, it is a change in lux level improvement from baseline. There are a lot of mutations we are looking into. LDNA—luminance-dependent navigation assessment—is a validated protocol. That is what we are aiming for, and that is what our analysis is going to be based on. As I said earlier as well, there is a lot of heterogeneity with clinical diagnoses, and syndromic and nonsyndromic forms. The clinical meaningfulness is greater than or equal to one lux level.
Shankar Musunuri: As Huma has stated, we validated this course during Phase 3 with real patients, and the course looks very robust. Based on our KOL input, they are extremely happy with this.
Elemer Piros: Thank you. What are some of the secondary endpoints that you would also look at to support that primary?
Huma Qamar: The secondary endpoints are visual acuity, low-luminance visual acuity, and patient-reported outcome scores. We will be looking into these, and that is very well agreed and aligned with the FDA.
Elemer Piros: One last question. Are both eyes treated? Could you remind us?
Huma Qamar: Yes, that is correct. Yes, if both eyes meet the inclusion/exclusion criteria, both eyes are treated. It is a 2:1 randomization, a single subretinal injection, and the control group will have a crossover after one year.
Elemer Piros: And then—
Shankar Musunuri: The study is the worst-eye for analytic analysis per SAP. So you would compare the worst eye to the control group.
Elemer Piros: The worst eye in that group.
Shankar Musunuri: Yes. The study eye is compared to the control group.
Elemer Piros: Thank you so much.
Shankar Musunuri: Thank you.
Operator: Our next question comes from the line of Daniil Gataulin from Chardan. Please go ahead.
Daniil Gataulin: Hi. This is Steven on for Daniil. Thanks for taking my question. For dry AMD, you mentioned a 50% responder rate. Were there any underlying characteristics that made a patient more likely to be a responder?
Huma Qamar: Are you talking about OCU410 GA? Yes. In terms of the responder rate, we have the inclusion/exclusion criteria, which were very uniform across the groups. Baseline characteristics included the mean age—we were looking at GA diagnosed at a certain age, with the mean in the mid-70s. We were also looking at the lesion size, which is pretty much well-versed with the OAKS and DERBY trials that Apellis got approval on—7.5 mm² was the mean, up to 8.03. In terms of the baseline characteristics, the responders responded on the medium dose as well as on the high dose. There was not really any other unique criterion that we would cite at this point until we get our final clinical study report. At this point, it seems like it was uniform across all dose groups.
Daniil Gataulin: Got it. Thank you.
Shankar Musunuri: Thank you. This concludes the Q&A portion.
Operator: I will now turn the call back over to Chairman, CEO, and Co-Founder, Dr. Shankar Musunuri.
Shankar Musunuri: Thank you, Operator. 2025 was marked by important clinical progress, strategic business development, and essential financing accomplishments across the organization. We are entering 2026 with strong momentum and a clear line of sight to multiple catalysts that will further advance Ocugen, Inc.'s position as a biotechnology leader in gene therapy for blindness diseases. We expect to deliver full Phase 2 data for OCU410 this month, complete enrollment for OCU410ST, initiate Phase 3 for OCU410 in geographic atrophy, and begin a rolling BLA submission for OCU400. I want to thank our employees, investigators, patients, and shareholders for their continued support. We look forward to updating you on our progress. Have a great day. The meeting is now concluded.
Operator: Thank you all for joining. You may now disconnect.