Financial Data and Key Metrics Changes - The company ended Q3 2025 with approximately $345 million in cash, not including about $445 million in net proceeds from an October equity financing [26] - The company has an expected cash runway into 2028, providing financial flexibility for ongoing clinical programs and potential commercialization [27] Business Line Data and Key Metrics Changes - The registrational programs for XPAXLY in Wet AMD and diabetic retinopathy are progressing well, with SOL1 on track for top-line data in Q1 2026 and SOLar reaching its target randomization of 555 subjects [28][29] - The SOL1 trial has over 95% patient retention, indicating strong engagement and compliance [15] Market Data and Key Metrics Changes - The global annual anti-VEGF market is estimated at approximately $15 billion, with significant opportunities for expansion due to high treatment discontinuation rates in Wet AMD and low treatment rates in diabetic retinopathy [9][10] - The company aims to capture a larger addressable market by reducing treatment burden and improving adherence, potentially reaching millions of untreated patients [11][28] Company Strategy and Development Direction - The company is focused on achieving a superiority label for XPAXLY, which could differentiate it from existing anti-VEGF therapies and insulate it from pricing pressures [7][8] - The strategy includes a triad approach: potential superiority, market expansion, and immediate adoptability, aiming to redefine the retina treatment landscape [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical strategy and market potential for XPAXLY, reinforced by positive feedback from payers and investors [26][27] - The company is committed to delivering long-lasting, clinically impactful therapies for retinal diseases, with a focus on early treatment to improve long-term outcomes [5][19] Other Important Information - The Helios program for diabetic retinopathy aims to pursue a broad label that encompasses both NPDR and DME, addressing a significant unmet need in the market [20][25] - The company has engaged with payers representing a large portion of U.S. commercial lives, receiving positive feedback on the potential of XPAXLY [14] Q&A Session Summary Question: What will the initial label for Wet AMD look like? - Management expects a superiority label based on SOL1, with flexibility for dosing intervals and repeat dosing [33][34] Question: What percentage of enrolled patients in Helios trials will have non-center-involved DME? - Management indicated confidence in achieving a broad label that includes all diabetic eye diseases based on previous study data [36][39] Question: What is the progress of NPDR studies? - Management confirmed that the process for NPDR studies began immediately after the recent financing, leveraging existing site relationships for efficient enrollment [56][59] Question: Are there risks associated with the ordinal two-step DRSS endpoint? - Management expressed great confidence in the ordinal endpoint, citing strong data from previous studies to support its validity [61][63] Question: How long will it take to complete enrollment for Helios 2? - Management believes there will be no issues in completing the trials efficiently due to high demand and enthusiasm from both patients and investigators [66]

Summary of Ocular Therapeutix 2025 Investor Day Company Overview - **Company**: Ocular Therapeutix (NasdaqGM: OCUL) - **Event**: 2025 Investor Day held on September 30, 2025 Key Industry Insights - **Industry Focus**: Retina treatment, specifically targeting wet age-related macular degeneration (AMD) and diabetic retinopathy - **Market Size**: The wet AMD market is estimated at $15 billion, but the company believes this is an underestimation, especially considering the potential for reducing dropout rates in treatment [14][17][21] Core Points and Arguments 1. **Company Evolution**: The company has undergone significant changes in culture and execution since the last Investor Day, transitioning from a culture-building phase to a focus on execution and positioning [4][6][25] 2. **Triad Positioning**: The company's strategy is based on a triad of superiority, market size, and seamless adaptability: - **Superiority**: The drug ex Paxley is on track to be the first and only drug with a superiority label versus anti-VEGF treatments, which is crucial for avoiding pricing pressures from generics and biosimilars [9][10][12] - **Market Size**: The company believes the market for wet AMD is larger than previously estimated, with a significant opportunity to reduce the dropout rate from the current 40% [14][17][19] - **Adaptability**: The drug is designed for seamless adoption in clinical practice, requiring no new equipment and maintaining existing workflows for physicians [22][23][60] 3. **Clinical Trials**: - **SOUL Program**: The SOUL program consists of multiple trials, including SOUL I, which is a superiority trial comparing ex Paxley to aflibercept, and SOLAR, which focuses on adaptability [33][34][46] - **Trial Design**: The SOUL I trial is designed to demonstrate superiority with a primary endpoint at week 36, with top-line data expected in 2026 [36][37] - **Patient Selection**: The trials focus on selecting strong anti-VEGF responders to ensure robust data and minimize dropout rates [39][50] 4. **Regulatory Alignment**: The company has secured a Special Protocol Agreement (SPA) with the FDA, which is critical for regulatory approval and market entry [39][54] 5. **Long-term Studies**: The SOLEX trial will follow patients from the SOUL trials to assess long-term effects and safety of ex Paxley, emphasizing the importance of continuous VEGF suppression [63][64] Additional Important Insights - **Treatment Burden**: Current treatment regimens lead to high dropout rates and poor adherence, highlighting the need for more durable therapies [80][82] - **Biosimilars Impact**: The introduction of biosimilars is expected to increase competition, but the superiority label of ex Paxley could provide a significant advantage in the market [87][84] - **Patient Experience**: The company emphasizes the importance of patient experience, noting that patients prefer treatments that require fewer injections, which could improve retention and adherence [90][92] Conclusion - Ocular Therapeutix is positioning itself to redefine the retina treatment landscape with its innovative drug ex Paxley, focusing on superiority, market potential, and seamless integration into existing treatment protocols. The ongoing clinical trials and regulatory strategies are designed to support this vision and address significant unmet needs in the retina treatment market.