Good morning, and welcome to the Ocular Therapeutix SOL-1 Top Line Data Conference Call. At this time, all participants are in a listen-only mode. After the prepared remarks, we will conduct a question-and-answer session. To our analysts joining us live, to ask a question, please use the Raise Hand feature under the Reactions button on the bottom of your Zoom screen. If you are unable to raise your hand, please let the LifeSci representative know in the chat box, and we'll make sure you are added to the queue. As a reminder, this conference call is being recorded, and a replay will be made available on the Investor Relations section of the Ocular Therapeutix website. This event will conclude at 9:00 A.M. Eastern. I would now like to turn the call over to Ocular Therapeutix's Vice President of Investor Relations, Bill Slattery Jr. Please go ahead, Mr. Slattery. Good morning, everyone, and thank you for joining us today. Earlier this morning, we issued a press release outlining the positive top-line results from our SOL-1 Phase 3 clinical trial of AXPAXLI, also referred to as OTX-TKI in wet AMD. Today's conference call will begin with prepared remarks from Dr. Pravin Dugel, Ocular's Executive Chairman, President, and CEO, Dr. Arshad Khanani, Director of Clinical Research at Sierra Eye Associates in Reno, Nevada, and Steering Committee Chair for the SOL program, and Dr. Darius Moshfeghi, who was a rescue monitor in the SOL-1 trial and is Chief of the Retina Division, Byers Eye Institute at Stanford University School of Medicine. Following the prepared remarks, Dr. Sanjay Nayak, Ocular's Chief Strategy Officer, will join Dr. Dugel, Dr. Khanani, and Dr. Moshfeghi for the question-and-answer session. We refer everyone to this morning's press release for a comprehensive update of the clinical data released today. During today's call, certain statements we will be making constitute forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially as a result of a variety of factors, including risks and uncertainties identified in the Risk Factors section of our annual report on Form 10-K and our other SEC filings. With that, I'd like to hand the call over to Dr. Pravin Dugel to provide an overview of today's announcement. Pravin? Thank you all for joining us on this historic day for Ocular Therapeutix, for the global retina community, and most importantly, for patients suffering from wet AMD. This morning, we announced positive top-line results from SOL-1. The data overwhelmingly show we have a drug, a drug that has the potential to fundamentally change what is possible in wet AMD treatment. Many of us were drawn to Ocular by the promise of AXPAXLI to help the millions of patients worldwide burdened by today's standard of care. Seeing that promise realized in a large, randomized, well-controlled phase 3 registrational trial is extremely satisfying. In SOL-1, AXPAXLI demonstrated sustained disease control, robust visual and anatomic outcomes, and a well-tolerated safety profile in a randomized population that was specifically selected to lose vision. We are thrilled to observe that 74.1% of subjects treated with AXPAXLI maintained vision through the week 36 primary endpoint, while 55.9% maintained central subfield thickness, or CSFT, within 30 microns of baseline in that same period. Maintenance of vision in SOL-1 is defined as a loss of less than 15 ETDRS letters of BCVA from baseline, aligned in our FDA-agreed statistical analysis plan. Such a level of consistent activity and long-term durability is remarkable. These strong results continued to week 52, where 65.9% of the AXPAXLI subjects maintained vision, and 44.1% of the AXPAXLI subjects maintained CSFT within 30 microns of baseline. That combination of visual and anatomic stability is rare from a single treatment, and we believe it is exactly what physicians, patients, and payers have been waiting for. Only after establishing that foundation do we arrive at what makes today truly historic. AXPAXLI did not just perform well, but it is now the first and only investigational product in wet AMD with a novel mechanism of action to successfully demonstrate superiority to an approved anti-VEGF. Let me repeat. AXPAXLI is now the first and only investigational product in wet AMD with a novel mechanism of action to successfully demonstrate superiority to an approved anti-VEGF agent since their initial approval in wet AMD more than 20 years ago. Many programs have tried to reach this bar. All have failed. Today, AXPAXLI succeeded. When I joined Ocular 2 years ago, we set out to orient the organization around a singular, bold mission: to redefine the retina experience. Our goal was to break the vicious cycle of treatment burden, discontinuation, and long-term vision loss by developing a therapy that patients can stay on and physicians can rely on. Today's historic milestone represents a monumental step towards that goal. SOL-1 shows that AXPAXLI can deliver sustained disease control with dramatically reduced treatment burden, and in doing so, it positions AXPAXLI as one of the most consequential advances in retina over the last decade. As a reminder, SOL-1 evaluated a single injection of AXPAXLI, 0.45 milligrams, versus a single injection of aflibercept 2 milligrams, administered after an 8-week loading segment with primary superiority endpoint at week 36, defined as the proportion of subjects maintaining vision, meaning less than 15 letter loss from baseline. The SOL-1 trial design and primary endpoint were explicitly designed to support a potential superiority label and were agreed to under a special protocol assessment agreement with the FDA. That primary endpoint was met convincingly with high statistical significance. The proportion of subjects who maintained vision at week 36 was 74.1% in the AXPAXLI arm, compared to 55.8% in the aflibercept two milligram arm, an observed difference of 18.3%, and as per the pre-specified statistical model, a risk difference of 17.5% with a p-value of 0.0006. This level of statistical significance gives us compelling evidence that we have a true drug effect with AXPAXLI. As you can see in the data shared today, and at the upcoming Macula Society Annual Meeting, the data are incredibly consistent. In addition to the primary endpoint, AXPAXLI shows high statistical significance or numerical superiority compared to aflibercept 2 mg for key secondary and exploratory endpoints. While the 15-letter superiority endpoint is essential from a regulatory perspective, it is not how retina specialists manage patients in practice. Clinically, we intervene much earlier based on smaller visual changes and, most importantly, anatomic control measured by OCT. Fluid accumulation is the earliest and most reliable predictor of future vision loss. Here, we believe the SOL-1 data are truly exceptional. AXPAXLI delivered likely best in disease anatomic control, with 55.9% of subjects maintaining CSFT within 30 microns from baseline through week 36, representing a relative risk difference of 17.1% in favor of AXPAXLI, with a nominal p-value equal to 0.0013, and sustained consistency beyond that time point, with 44.1% of subjects maintaining CSFT within 30 microns through week 52. That level of fluid stability after a single treatment has simply never been reported before in a clinical trial. Taken together, these data provide very strong evidence that AXPAXLI can provide proactive, predictable, and sustainable disease management, rather than the reactive, unpredictable, and short-acting paradigm that has defined wet AMD care for more than two decades. And it is precisely because AXPAXLI delivered this level of consistent, durable disease control, that it was able to do something no other therapy has accomplished: demonstrate superiority to an approved anti-VEGF agent in a phase 3 FDA-aligned trial. Superiority was not achieved in isolation. We believe it was the result of strong activity, longer durability, and consistent control of disease over time. Equally important, AXPAXLI demonstrated a reassuring safety profile in SOL-1. In retina, safety signals have repeatedly derailed otherwise promising therapies, often signaled early in clinical data sets and ultimately limiting approval or adoption. AXPAXLI was generally well-tolerated in SOL-1, with no observed treatment-related ocular or systemic serious adverse events. Durability without compromising safety is what enables real-world adoption. AXPAXLI delivered both i n this trial. These outstanding SOL-1 results further strengthen my confidence in SOL-R. A trial that is prospectively evaluating fixed six-month dosing and is being conducted in a patient population likely to be much more stable and easier to control. Newly diagnosed wet AMD subjects were only randomized in SOL-1 after showing a peak response to two aflibercept 2 mg injections, reaching approximately 20/20 vision or experiencing an improvement of at least 10 ETDRS letters of BCVA. This population was specifically selected to lose vision. If AXPAXLI can deliver this level of disease control in the SOL-1 population, we should expect even stronger durability signals and higher rescue-free rates with populations such as the one randomized in SOL-R, which incorporates an extensive six-month screening and loading phase to exclude subjects with early persistent fluid or significant retinal fluid fluctuations. If approved, I believe AXPAXLI is exceptionally well-positioned for immediate and broad adoption, given its safety profile, transformative durability, and seamless fit into existing retinal practice dynamics, requiring no surgery, no concomitant steroids, and no workflow disruptions. With that backdrop, I am delighted to be joined today by two of the world's foremost investigators in retinal therapeutics, Dr. Arshad Khanani, Steering Committee Chair for the SOL-1 program and Director of Clinical Research at Sierra Eye Associates, and Dr. Darius Moshfeghi, Chief of the Retina Division at the Byers Eye Institute at Stanford University School of Medicine, and a rescue monitor in SOL-1. Their perspectives will be invaluable in helping frame the clinical relevance of today's results. Before I turn to Arshad, I want to emphasize that today's announcement represents only top-line results from SOL-1. We continue to diligently work through all the data received, and we are thrilled with the consistency and strength of the data across the board. We look forward to sharing detailed results at the 49th Macula Society Annual Meeting in just over a week's time. With that in mind, Arshad, please go ahead. Thank you, Pravin, and a huge congratulations to the Ocular team on what I believe is truly a defining day for wet AMD care. I'll start with a very simple statement. If AXPAXLI were available tomorrow, I believe retinal physicians would use it immediately and broadly in their patients with wet AMD. They would use it because the SOL-1 data show this is an active, durable, and well-tolerated product candidate that delivers a level of predictable disease control we simply don't have today in clinic. As a reminder, SOL-1 results were achieved in a population that was specifically selected to lose vision after the loading phase, which suggests the potential for even better disease control in more stable patients. Having served as a steering committee chair for the SOL program, I've had a front-row seat to both the rigor of this trial and the quality of the data it produced. The bar for success in SOL-1 was very high, and the result is a clean, consistent, and interpretable data set that allows us to draw confident clinical conclusions and meaningfully reassess what is possible in wet AMD disease management in the near future. For more than two decades, anti-VEGF injections have defined wet AMD treatment. Progress has largely come in the form of incremental one- to two-week improvements in real-world durability, often without corresponding improvements in long-term outcomes. Despite these advances, up to 40% of patients still discontinue therapy within the first year alone, largely due to treatment burden, placing them at risk for avoidable visual loss. The opportunity to deliver sustained disease control with dramatically less frequent dosing is not incremental. It represents a logical and long-overdue paradigm shift for patients, physicians, and payers. Based on the SOL-1 data, that shift now appears attainable with AXPAXLI. To appreciate the significance of SOL-1, it's important to first understand just how challenging it is to meet this primary endpoint. As a first-of-its-kind study, SOL-1 addressed a question the retina field simply did not have high-quality data to answer: How long does it take newly diagnosed patients with wet AMD to lose 3 lines or 15 letters of visual acuity in the modern treatment era? What we now know from this landmark study is that a 15-letter decline typically reflects slow, progressive anatomic deterioration of the fovea, the portion of the retina responsible for central vision.... Put simply, the bar for demonstrating superiority is extremely high. That is precisely why the FDA insists on this endpoint, and why no other product with a novel mechanism of action, approved or in development, has demonstrated superiority to an approved anti-VEGF. Seeing that AXPAXLI met this superiority primary endpoint, with 74.1% of patients maintaining vision at week 36 and 65.9% of patients at week 52, provides clear evidence of the potency and durability of AXPAXLI's VEGF suppression in patients with wet AMD. But as a clinician, what matters most to me is not just that AXPAXLI cleared this hurdle, it's that it did so while delivering the kind of durability, consistent disease control, combined with a favorable safety profile that could actually change how I would manage patients. From a regulatory standpoint, based on the SOL-1 SPA agreement with the FDA, the data suggests that AXPAXLI was clearly successful in showing statistical superiority. But in practice, retina specialists do not wait for patients to lose three lines of vision before intervening. We make decisions based on earlier functional changes and anatomic control based on fluid on OCT imaging. We tend to prioritize anatomic control, first and foremost, because it is typically the earliest indicator of disease progression and future vision loss. Our goal is not to just suppress fluid, but also to maintain stable and consistent anatomic control over time, minimizing both the presence of fluid and its fluctuation, which have been associated with irreversible vision loss. This is where the SOL-1 data become extremely compelling. We saw sustained and tighter fluid control with AXPAXLI through the week 36 primary endpoint, and clear separation from the aflibercept arm, which experienced significantly more accumulation of fluid. 55.9% of patients treated with AXPAXLI maintained central subfield thickness within 30 microns from baseline at week 36, compared to 37.8% of patients in the aflibercept arm. This reflects a 17.1% risk difference with a nominal P value of 0.0013, which is highly significant. This level of sustained anatomic stability reflects a degree of predictable and durable disease control that extends far beyond what we typically achieve with available therapies today. A therapy that can reliably maintain anatomic outcomes for 6-12 months for the majority of patients would represent a major paradigm shift from the current standard of care. In addition, SOL-1 provides durability insights over an extended horizon of up to 12 months, something we simply do not have for any other pivotal program in wet AMD to date. Importantly, we now have this data in a population where vision loss is inevitable. Newly diagnosed patients randomized after showing strong response to aflibercept 2 mg. Looking at the results, the week 24 rescue-free rate in SOL-1 stands out. 80.6% of AXPAXLI treated subjects were rescue-free, based on the pre-specified protocol definition of less than 15 letters lost from baseline or no new vision-threatening hemorrhage, which is not the typical clinical bar for rescues for retinal physicians. To put these findings in the context of real-world clinical practice, we can consider the rescue criteria used in Ocular's ongoing non-inferiority trial, SOL-R. The on-protocol rescue criteria in SOL-R is a greater than 5 letter loss of vision, combined with a central subfield thickness increase of more than 75 microns. Criteria that closely mirror how retina specialists make retreatment decisions in the clinic. When those SOL-R rescue criteria are applied to the SOL-1 data set, the results continue to remain outstanding. Even within SOL-1's population that was selected to lose vision, approximately 80% of AXPAXLI-treated patients would still have remained rescue-free at six months under the SOL-R criteria. Looking to SOL-R, which is prospectively evaluating six-month dosing in a population that is substantially more likely to be stable and easier to control, I expect rescue-free rates in the AXPAXLI arm to be even higher than what we have seen in SOL-1. Taking these together, these findings provide a clear and clinically relevant bridge from SOL-1 to SOL-R, and reinforce the potential for predictable, fixed-interval dosing with AXPAXLI in real-world practice. To summarize, as retina specialists, we often find ourselves negotiating treatment intervals with patients. The treatment burden with current standard of care remains high and leads to poor long-term vision outcomes in real-world practice. This data from SOL-1, highlighting the durability, the consistency of anatomic control, the rescue-free rates, and the safety profile, makes AXPAXLI a potential agent that can offer patients a significant reduction in treatment burden while maintaining tight disease control. I expect AXPAXLI would be adopted by retinal specialists immediately if approved. To further explore what these findings may mean for SOL-R and to share additional perspective on what this means for potential real-world adoption, it is my pleasure to turn the call over to my colleague and a world-renowned retina expert, Dr. Darius Moshfeghi. Darius? Thanks, Arshad. I echo your congratulations to the ocular team. It's an honor to be here on a day that I believe has redefined what's possible for our patients with wet AMD. I was an independent rescue monitor for the SOL-1 trial, and the mandate was clear: Every decision was about ensuring patient safety and protocol adherence while building evidence to help many more patients in the future. In retrospect, that responsibility was facilitated by AXPAXLI's strong durability and well-tolerated safety profile. When you think about it carefully, durability itself is a safety feature, particularly when measured in months. With any other anti-VEGF treatment, one missed visit can result in irreversible vision loss in the time period between 8 and 20 weeks. Due to other health issues, their own family concerns, transportation issues, loss to follow-up, this is a very common occurrence in these elderly patients, especially in a treatment-extend paradigm. AXPAXLI has the potential to provide a meaningful buffer between treatments out to 36-52 weeks, maintaining disease control longer and possibly keeping patients safer over time, with the potential for better long-term visual outcomes. SOL-1 provides exceptionally strong evidence that AXPAXLI has the potential to stand in a class of its own, combining potent VEGF suppression with a level of visual gain durability that meaningfully resets expectations for disease control. Because SOL-1 is a first-of-its-kind study, the secondary and exploratory endpoints will be closely analyzed. Importantly, SOL-1 does more than demonstrate superiority, which itself is an incredibly rare achievement in retina and wet AMD in particular. It also validates the underlying durability hypothesis for a fixed six-month dosing paradigm, precisely what SOL-R is prospectively designed to confirm. Like Arshad, I'm struck by the finding that when SOL-R rescue criteria are applied to SOL-1, approximately 80% of AXPAXLI-treated patients would have remained rescue-free through week 24. This particularly stands out because in order to be randomized in SOL-1, patients needed to gain at least 10 letters of vision during the 8-week loading period or achieve 20/20 vision, meaning these patients have already shown peak response to two aflibercept 2-mg injections by the time they are randomized and therefore are selected precisely because they're expected to lose vision from this point. By contrast, SOL-R incorporates an extensive six-month screening and loading phase, specifically designed to remove patients with high fluid fluctuations, resulting in a randomized population that is more stable and easier to control. In that setting, I would reasonably predict AXPAXLI's durability signals, including rescue-free rates, to be even stronger. If approved, AXPAXLI is very well positioned for rapid adoption. This agent delivers exactly what the data-driven retina community is looking for to alter their practice patterns: good safety, durable visual gain maintenance and fluid control, predictable dosing, and a seamless integration into clinic workflow. From a clinician's perspective, this is the kind of data set that gives you confidence to rapidly integrate AXPAXLI, if approved, into your wet AMD treatment regimen. Let me briefly walk through why. First, safety is king, and there were no safety concerns in this study. Every single retina specialist will tell you that safety is at the forefront of everything we do. It remains the non-negotiable foundation for adaptability of new treatments. We've all seen promising therapies fail in development due to serious inflammatory signals or other concerns that eventually complicate real-world adoption. As we can see from the data, the safety profiles between the two study arms in SOL-1 are nearly indistinguishable. AXPAXLI was generally well-tolerated in SOL-1, with no observed treatment-related ocular or systemic serious adverse events, SAEs. Importantly, more than 95% of patients reached the week 52 durability assessment, and we've not seen meaningful discontinuations following repeat dosing within that time period. This is unlikely to have been the case if there were any significant safety concerns. Second, AXPAXLI's durability, as manifested by stabilization of vision gains observed in SOL-1, is truly transformative. In the AXPAXLI arm, on-protocol rescue-free rates were an incredible 80.6%, 74.7%, and 68.8% at weeks 24, 36, and 52, respectively. These levels of visual gain durability at 6, 9, and 12 months with a single treatment immediately offers patients the potential for a more predictable dosing option, which should improve long-term visual improvement gains, reduce the risk of visual loss due to vision attrition, and free up valuable clinical capacity. Crucially, SOL-1 evaluated the durability of a single dose of AXPAXLI in a cadence-matched head-to-head fashion versus a single dose of EYLEA aflibercept 2 mg, showing highly statistically significant differentiation and leaving little ambiguity about the durability of effect on vision maintenance. This stands in contrast to other recently approved agents and ongoing clinical trials, where durability effects were inferred rather than directly tested under identical dosing conditions. Third, durability alone is not enough. Dosing predictability over time matters. Clinicians adopt therapies based on predictable dosing and disease activity control across months. In SOL-1, approximately 80% of AXPAXLI patients would have maintained vision through 6 months using the SOL-R criteria, as well as anatomic stability. This anatomic stability continued out to week 52, where 44% of AXPAXLI-treated patients maintained central subfield thickness within 30 microns of baseline. That level of consistency is what can drive real and immediate changes to the treatment paradigm. Based on the SOL-1 dataset, AXPAXLI has the potential to stand out as a best-in-disease treatment option, not just best in class. To my knowledge, AXPAXLI includes the most potent TKI studied in retina to date. It is highly unlikely that an agent with less potency or durability could have been as successful in a trial with the SOL-1 design. Fourth, AXPAXLI will seamlessly fit into existing workflows. AXPAXLI, which is fully bioresorbable, requires no surgery, no concomitant steroid regimens, and no new burdensome monitoring paradigm for remnant accumulation. If approved, it would fit seamlessly into existing practice patterns and over time, may even optimize practices as the field shifts towards fixed-interval dosing. Fifth, and finally, superiority claims are scarce because they are difficult to achieve. A superiority claim resets the standard by which other agents will be assessed. It represents a durable point of differentiation and may help mitigate step edits that often constrain uptake of agents approved solely on the basis of non-inferiority. Taken together, a good safety profile and the remarkable durability of visual maintenance observed with a single dose of AXPAXLI against aflibercept 2 mg in a head-to-head superiority trial demonstrated in SOL-1, combined with the consistent and predictable fluid control and potential for seamless workflow integration, AXPAXLI represents a rare and uniquely compelling combination. AXPAXLI's SOL-1 performance is exactly the type of product profile that I would expect to see rapid day one adoption, if approved. In my view, AXPAXLI represents the most consequential advance in wet AMD since the approval of the first anti-VEGF therapy over 20 years ago. Pravin, back to you. Thank you, Darius and Arshad. Your perspectives carry tremendous weight within the retina community, and we are grateful for your thoughtful contributions today. From a clinical perspective, as you've heard from both Arshad and Darius, what matters most in the day-to-day retinal practice is consistent and sustained anatomic control. In SOL-1, AXPAXLI delivered exactly that, providing evidence of the predictability clinicians need to confidently extend treatment intervals. From a strategic standpoint, the implications of SOL-1 are profound. Historically, the wet AMD market has rewarded durability, even incremental improvements of one or two weeks. In SOL-1, AXPAXLI demonstrated durability that extended out to week 52 with an unprecedented two-thirds of subjects maintaining vision. Just as importantly, AXPAXLI is designed to fit seamlessly into current retinal practice dynamics, as Darius highlighted. If approved with a superiority label, AXPAXLI could also bypass payer step edits, which have historically been a limitation on novel therapies in wet AMD. Taken together, these attributes support a likely therapy that is, one, immediately adaptable. Two, potentially practice expanding at a time when the number of patients needing retinal care continues to expand. Retinal specialists could potentially see more patients less often. And three, highly aligned with payer incentives. For patients and caregivers, this can mean improved quality of life with reduced treatment burden. For physicians, it means simplified logistics and fewer capacity constraints. For payers, it means potentially improved long-term outcomes and lower total cost of care, driven by fewer patients going blind. Looking ahead, we believe the strength and statistical integrity of SOL-1 data provide a clear path toward regulatory submission. Consistent with recent FDA commentary, we believe SOL-1 represents exactly the type of single, well-controlled, FDA-aligned registrational trial that can support an NDA filing. Accordingly, we plan to hold formal discussions with the FDA and pursue approval through the accelerated 505(b)(2) pathway thereafter... If approved, AXPAXLI could become the first TKI to reach the retinal market and the only therapy in wet AMD with a superiority label compared to an anti-VEGF agent. This possible accelerated NDA strategy does not alter our ongoing SOL-R non-inferiority trial, which completed randomization in December 2025 and is expected to have top-line data in the first quarter of 2027. SOL-R remains an important component of our global regulatory and commercial strategy, and today's SOL-1 results only strengthen our confidence in its outcome. In closing, let me briefly recap today's significance. SOL-1 provides robust evidence that AXPAXLI is an active, durable, and well-tolerated product candidate, delivering consistent visual and anatomic disease control in a population that is inherently difficult to manage. AXPAXLI is the first and only novel agent to demonstrate statistical superiority to an anti-VEGF in a phase 3 FDA-aligned trial in wet AMD, clearing a bar that has eluded the field for more than two decades. The clinical relevance of these data is underscored by robust secondary outcomes, including sustained anatomic control, with 55.9% of AXPAXLI subjects maintaining CSFT within 30 microns at week 36 and 44.1% at week 52. AXPAXLI demonstrated exceptional durability in SOL-1, with 74.1% of AXPAXLI patients maintaining vision through week 36 and 65.9% through week 52, supporting the potential for extended dosing intervals of up to 12 months. AXPAXLI was generally well tolerated, with no observed treatment-related ocular or systemic serious adverse events, providing high confidence for real-world adoption. SOL-1 should provide a clear and clinically intuitive read-through to SOL-R, which is designed to confirm non-inferiority in a fixed six-month dosing interval in a population that is likely to be more stable and easier to control. Applying the SOL-R rescue criteria to SOL-1, 77.1% of AXPAXLI patients would have remained rescue-free at week 24, and we expect this number will be even higher in SOL-R. Based on the strength and integrity of the SOL-1 data set, we intend to submit an NDA subject to planned formal discussions with the FDA, positioning AXPAXLI to potentially become the first TKI in retina and the only therapy in wet AMD with a superiority label compared to an anti-VEGF agent. Together, these elements define how we intend to redefine the retina experience, anchored by a robust patent estate extending into 2044 and providing the foundation for disciplined life cycle investment, long-term differentiation, and sustained value creation. We look forward to our first clinical data presentation of the SOL-1 data set at the upcoming Macula Society meeting. Before we move to the Q&A portion of the call, I want to sincerely thank the investigators, the patients and their families who made this study possible, and the Ocular team, whose relentless commitment carried us to this moment. I'd also like to take a moment to provide an update on Donald Notman, our CFO and COO. As I know, several of you reached out after we announced his temporary medical leave of absence. Donald is doing very well. He does not yet have a specific timetable to return, but we expect he will be back at some point soon. I think you'll all join me in wishing Donald the very best. Today's results mark a defining moment for Ocular and for the retina field, and we're energized by the opportunity to build the future of retinal care from here. Operator, can you now open the call for questions? Great. Thank you, Pravin. So at this time, we will be conducting a question-and-answer session with our speakers. As a reminder to our analysts who have joined us live, if you would like to ask a question, please use the Raise Hand feature under the Reactions button on the bottom of your Zoom. If you are unable to raise your hand, please let the LifeSci representative know in the chat box, and we'll make sure you are added to the queue. Please hold for a brief moment while we pull for questions. So our first question comes from Biren Amin at Piper Sandler. Please go ahead. Hi, guys. Thanks for taking my questions, and congrats on the data. I wanted to ask regarding read throughs to SOL-R. Given the data set that you presented today, what do you think the data set tells you regarding achieving non-inferiority on BCVA versus EYLEA 2 mg every 8 weeks? And then second question relates to the aflibercept arm and so on. Just your thoughts on the outperformance of the rescue-free rate, and also, you know, lack of significant letter changes in the control arm, and what do you think led to those results, given the aflibercept PK level should be minimal at week 36? Thank you. Biren, good morning, and thank you for the thoughtful questions. We're really fortunate to have both Arshad and Darius here, so we'll take advantage of them and let them do most of the talking instead of me. Arshad, why don't you go ahead and take that first? Thank you, Biren. Good morning, everybody. So Biren, the first question was about translation from SOL-1 to SOL-R. As you're aware, SOL-R has a long running phase, and patients who have any fluctuations or fluid accumulation are excluded. So we are looking forward to. You know, we've enrolled the patients who actually have very controlled disease. And in SOL-1, obviously, we had a population that was much higher need than SOL-R. So looking at, obviously, the rescue-free criteria that we applied to SOL-1 dataset, approximately, you know, 80% of patients were rescue free, would be, you know, in the SOL-R study using the SOL-R criteria based on SOL-1 data. So I'm highly confident that because the patient population is less high need, I think we'll be able to show non-inferiority potentially in SOL-R. Remember, you know, when you are looking at a large heterogeneous patient population, patients who drive vision down are the high, high need patients, and we don't have those patients in SOL-1. In terms of the control arm in SOL-1, and when you look at the rescue-free subjects at nine months with vision and anatomy, I think we need to keep in mind that a lot more patients in the aflibercept 2-milligram group got rescued. You know, the rescue-free rate in it actually was 74.7%, and in aflibercept was 56.4%. So when you look at these patients, you know, what happens is that the patients who are moderate or high need were already rescued. So, you know, as I said, it's a heterogeneous disease, and in this disease, patients will need treatment if they have fluid accumulation. I think the control arm, you know, is a subset where we have never studied this before, but I'm not surprised that there are some patients in the aflibercept group that went a long time without needing any treatment, from my perspective. Pravin? Thank you. Thank you, Arshad. Darius, let me give it over to you, and maybe you can answer those questions as well from your perspective. Yeah. Thank you, both Pravin and Biren. You know, these are two different trials. SOL-1 really focused on strong responders to visual acuity to anti-VEGF, with good visual acuity and a proven fluid response. Whereas in SOL-R, it's a highly selective population with less vision and greater CSFT variability. When we look at it, we see from the SOL-1 subset that about 77% of the patients would have maintained a treatment-free interval at six months. And when you go into that more refined population of SOL-R, I actually think we're going to actually have much better results in that population. Going to your second question, why did the control arm do so well? I mean, it's really remarkable that the control arm did that well, much better than anyone expected, and yet AXPAXLI still beat the superiority outcome. This is pretty much the hardest thing to do in retinas, hit superiority in wet AMD, particularly when your comparator brings their A game, and AXPAXLI did it. You brought up the PK values. We know that fluid substantially leads visual acuity loss, and so we have not ever had a data or any other trial that has showed this sort of approach, where you give a single dose and see how long it lasts. What we're learning here is that impact can last a while. These were treatment-naive patients. They could only get in if they got up to 20/20 or gained 10 letters. Frankly, this is the first data that we have on patients who had 3 injections and then were followed for either vision loss or vision-threatening macular hemorrhages. So while we may have anticipated that the aflibercept arm would have done worse, it shows how long it actually takes to lose 15 letters after a loading regimen, and it's a testament to the strength and durability of AXPAXLI, that it was still able to maintain a superiority outcome against aflibercept, when it's doing much better than anticipated. Darius, thank you. And Biren, just my two cents on the control arm. So, let me just give that to you because it's a question that I'm sure is on everybody's mind. There are a couple of things that I've learned from this. The first thing that it's taught me, and again, realize that this has never been looked at before in any other study. The first thing that it taught me is how long it takes from the loss of a drug effect to OCT fluid accumulation, to vision loss, and not just any vision loss, vision loss of 15 letters or 3 lines. That's a lot of vision loss. It takes a very long time. This is consistent with the fact that in all the earlier clinically relevant parameters, most importantly, the OCT, AXPAXLI clearly beat EYLEA in every single one of them consistently. So what's the relevance of this? Well, as Darius mentioned, the bar for superiority is extraordinarily high, and we managed to hit it. Nobody else has for almost a quarter century. What that means also is that if we're fortunate enough to be approved with a superiority label, we will not only be in a different orbit, but we'll be completely protected. I think it's very unlikely that anybody will dare do a superiority trial, seeing what they saw today. So again, we'll be in a great position if we're fortunate enough to be approved with a superiority label. Again, a different orbit and completely protected. The other part that I have to add is, look, this discussion regarding the control arm is a purely academic exercise. It has absolutely no practical or clinical relevance whatsoever. I don't think there's any clinician that's going to look at the SOL-1 data and say, "Now, after two decades, I'm going to completely change the way I use EYLEA." I don't think anybody's going to go out there and say, "You know, starting tomorrow, I'm going to give three shots of EYLEA and wait for the patient to lose 15 letters of vision." So it is an academic exercise. It really has absolutely no clinical relevance whatsoever. And as Darius said, despite all of this, the bottom line is that AXPAXLI beat the EYLEA arm in every single clinically relevant parameter. That's really the most important point. The data are incredibly convincing. They're absolutely, absolutely consistent, and AXPAXLI achieved what no other drug has ever achieved, in a, in a quarter century. It's superior to an anti-VEGF. The reason that this is a historic day is not only do we have a drug, but we have a drug that's potentially better than the anti-VEGFs, and that really, that's the bottom line. Back to you. Thank you, Biren. Great. Thank you for the questions, Biren. Our next question comes from Tara Bancroft at TD Cowen. Please go ahead, Tara. Thanks. Good morning, and congrats on the success of the trial. It's certainly no small feat. But also, I really want to extend my well wishes to Donald. We miss him. So I guess my question is: I'm wondering if you could give us some more context for how the vision and the CST curves compared in the overall ITT population, including those who were rescued, and if those ITT curves will be shown at Macula or other future conference. Thanks. Tara, thank you for the question, and good morning. And again, I'm very, very happy to say that Donald is doing very well, and we also miss him a lot. As far as the Macula Society presentation is, goes, you know, what I would tell you is, look, we're still putting all the data together. We certainly will have more data at the Macula Society presentation. We look forward to showing all the data, as soon as we can, but it does take a little bit of time, and the team is working diligently on that. But your questions regarding what we see, particularly in patients who are rescue-free, in both arms, are very relevant, and thank you for that. So let me pass it on to Arshad first. Arshad, what are your impressions of the question that you know Tara had in regards to what you've seen so far with the visual acuity results as well as the OCT results? Thanks, Pravin. I think that's a very clinically relevant question because, you know, patients in clinical practice, we are not allowing them to lose 15 letters. We want to control fluid, as I said. So I think when you look at vision, vision appears to be maintained in majority of the patients, and majority of the patients, 74.7% at 9 months, are rescue free. But I think clinicians treat patients based on anatomy. And when you look at the anatomy, you see very large separation between AXPAXLI and aflibercept. And again, as I said earlier, 74.7% of patients treated with AXPAXLI are rescue free and only 56.4% of patients with aflibercept. So when we look at patients, you know, I can predictably say that majority of the patients will have good anatomic control that's sustained and durable. You know, this is a drug that can easily go 9 months, if not 12 months. I think looking at the CSFT fluctuation or CSFT, CSFT change within 30 microns is super crucial for the retina community. 55.9% of patients in the AXPAXLI arm at week 36 maintain CSFT within 30 microns. We know that CSFT fluctuations of 50 microns or more lead to irreversible vision loss over time. So we have a drug here that can actually have sustained disease control for a period of 9-12 months, and that number for week 52 was 44.1%. So as a clinician, the most important data set, obviously. From today, in terms of efficacy, is the sustained anatomic control that we are seeing from AXPAXLI, which obviously is going to be very meaningful for our patients in clinical practice. Arshad, thank you. Darius, to you with Tara's question, or maybe a slight modification of that, which is really, maybe I can ask more directly, which is: Given everything that you've seen, given the data that we've managed to put together so far, maybe you can talk a little bit about the adoptability of this drug in your practice. Thank you. I'll try to address all of that, Pravin and Tara. We view these results from the perspective of maintenance of visual acuity, the less than 15 letters lost from baseline. However, our subjects are viewing it differently. They gained 10 letters and then held on to 7 letters at week 36. From their perspective, our subjects in this trial gained vision. It's like I gave you $10 and sent you off for 9 months, and you came back with $7. Are you ahead or you're behind? From our subjects' perspective and your perspective, you're ahead. Based on that, I think this is going to lead to rapid adoption in our clinics, because why wouldn't you give your patients all the opportunity to be ahead, regardless of when it kicks in? When I look at those curves on visual preservation over time, I see that we really see it going kind of plateauing for the AXPAXLI arm at around 12 weeks. We don't really see the plateau on the aflibercept until around 24 weeks. I want to get and lock in my patients' visual acuity as fast as possible, and that's why I would convert my patients to AXPAXLI if this was adopted. Since it's doing something we're already doing, which is an intravitreal injection, it would be seamlessly integrated into my clinic. And as both Arshad and Pravin have pointed out, we're really locking in our CSFT control with 55% within 30 microns of their baseline CSFT out at 36 weeks. Overall, visual preservation and CSFT control is giving us a very predictable option and driving more and more of us towards a fixed dosing sort of world, where we can be looking at 6, 9, and potentially 12 months dosing. Thank you, Darius, and I agree with you. I think from my perspective, to show evidence of disease control, you know, that stability of CSFT within 30 microns at 36 weeks is really the most objective and the most impressive. Operator, maybe one last final question. I know we're up against the clock, but maybe one more question and then I will cut it off, but please go ahead. Great. Sounds good. Yes, thank you for the questions, Tara. Our final question comes from Tazeen Ahmad at Bank of America. Tazeen, please go ahead. Being that you're on your phone, you may need to press star six to unmute your line. Okay. Can you hear me now? Yes. Yes, we can. Okay. Sorry about that. Thanks for all the details that you've provided on this study. I wanted to ask, just in general, a couple of questions. For a physician, just based on the data that's been presented so far from SOL-1, what additional color do you think at all they would need from SOL-R in order to make this a meaningful part of their practice in terms of prescriptions to patients? And then just in general, on safety, it was good to see no serious side effects. I wanted to maybe follow up on, I guess, numerically slightly higher incidence of cataracts seen in the study and get your opinion on if that's clinically meaningful. Thanks. Yeah. Good morning, Tazeen, and thank you for your question. Arshad, maybe start with you in terms of the questions that Tazeen asked. Yeah. Hi, Tazeen. So I think, you know, the question about what are we looking for for SOL-R is we are dosing patients every six months. So I think establishing efficacy as well as safety of every six-month dosing obviously will be the goal. Efficacy, we have obviously seen that this drug can go six, nine, or twelve months in majority of the patients. So I think it will be for the label, mainly to get that six months dosing. As you know, in the first year, patients only receive one AXPAXLI injection in SOL-1. When I look at adverse event profile, you know, it's important for me to point out a few things. Things I'm looking for is intraocular inflammation, number one, which is the reason many potent drugs have failed to be commercially utilized significantly, and that rate is less than 2%. I'm looking at any cases of retinal vasculitis or occlusive retinal vasculitis or endophthalmitis, and none of those cases are reported in this trial, in the data set. In terms of cataracts, this is an elderly patient population, and the numbers actually are very low. So I'm not surprised that there's a few patients here and there in terms of the difference, but I don't think that's meaningfully different. But obviously, we'll look at the data in more detail as is available. So bottom line, at this point, I'm not concerned about anything in the safety. The safety looks clean, and I think this is the biggest reason that physicians will adopt this product quickly and broadly, because it appears to be- ... comparable in safety while bringing superiority, tight fluid control, and protection of our patients in terms of vision, by having sustained disease control over time. Thanks, Arshad, and Darius, final word to you. You emphasized in the opening the importance of safety. Maybe your impressions on the safety profile for AXPAXLI. You know, Pravin, you're stealing my thunder once again. Tazeen, thank you for your questions. As I noted in my first comment, safety is king, and I was, along with Barry and Carl, the rescue monitors for this. So we saw most things that came across regarding visual acuity change into our vision-threatening macular hemorrhage, and we had no safety concerns whatsoever in this trial. From a visual acuity maintenance perspective, and then from the durability perspective, I need no other data to rapidly offer this if it's approved to all of my wet AMD patients. The first thing it does for me is it introduces dosing predictability. As a fixed dosing adherent for the last 20 years, the ability to predictably dose now between nine and 12 months is transformative for both my patients and my clinic. Second, it introduces peace of mind. If my patient misses a visit, becomes ill or incapacitated, or they have to take care of their family members, or simply want to travel more, they don't have to worry about the trade-off of missing a visit versus dealing with life's complexities. AXPAXLI is a smoothing function for visual acuity maintenance. Again, regarding the cataracts, I agree with what's been said already, which is this: It's an elderly patient population. Nothing was deemed treatment-related or procedure-related. And so overall, this is a very transformative drug for our patient population, and if it gets approved, I, I believe it will be rapidly adopted. Thank you, Darius. Operator, back to you, and thank you, Tazeen, for the question. Great. Yes, thank you, Tazeen. This concludes our Q&A session today. Pravin, I'll turn it back over to you for closing remarks. Thank you. Thank you. Before we conclude, I want to reiterate how excited and encouraged we are by the SOL-1 results discussed today. This was a landmark study, and its success is a direct reflection of the extraordinary commitment of the patients who participated, the investigators who executed the trial with rigor and care, and the entire Ocular Therapeutix team who brought this program to life. I am deeply, deeply grateful to all of them. We look forward to sharing more exciting details from the SOL-1 dataset at the upcoming 49th Macula Society Annual Meeting next week. Thank you all for your time today, your thoughtful questions, and for joining us in what is a defining day for Ocular Therapeutix and the future of wet AMD care. Have a great day, everyone, and thank you.