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Core Points - Ocular is preparing to share its story and engage with stakeholders during the presentation [1] - The presentation will include forward-looking statements that are subject to risks and uncertainties [1] Company Overview - Dr. Pravin Dugel serves as Ocular's Executive Chairman, President, and CEO [2]

Core Points - Ocular is preparing to share its story and engage with stakeholders during the presentation [1] - The presentation will include forward-looking statements that are subject to risks and uncertainties [1] Company Leadership - Dr. Pravin Dugel serves as Ocular's Executive Chairman, President, and CEO [2]

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.

AXPAXLI's Clinical Development and Regulatory Strategy - Ocular Therapeutix is targeting the FIRST SUPERIORITY LABEL vs anti-VEGFs for AXPAXLI [26, 29, 32, 35, 38] - AXPAXLI has SPA Agreements for SOL-1 & HELIOS-2 Trials, supporting a regulatory path for a superiority label [36] - SOL-1 is designed for success with FDA alignment through SPA, randomization of strong anti-VEGF responders, and the potential for a superiority claim on the label [133, 134, 136, 137, 140, 141, 152, 153] - SOL-R is designed for seamless, immediate adoption with methodical patient selection to exclude subjects with early persistent fluid [93, 94, 95, 96, 97, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 233, 234, 235, 236, 237] - The company plans for AXPAXLI NDA submission following SOL-R 56-Week Topline Data, with a package expected to exceed the requirements for FDA's safety database [230, 231, 232] AXPAXLI's Commercial Potential and Market Opportunity - The 2024 Global Branded Anti-VEGF Revenue is $15 Billion, indicating a significant market size [49, 52, 55] - AXPAXLI has the opportunity to significantly expand the $15B Global Retina Market by redefining the treatment attrition curve in wet AMD and establishing a standard of care in NPDR [57, 58, 59, 60, 82, 83, 84, 85, 86, 87, 88, 89, 90] - There are 18 million people with wet AMD in the U S, with 40% discontinuing treatment in the first year, presenting an opportunity for AXPAXLI to improve adherence [57, 59, 83, 86] - There are 64 million people with NPDR in the U S, with less than 1% of patients currently treated, indicating a large undertreated population [86, 89] Expansion into Diabetic Retinopathy - The company is targeting a broad indication in Diabetic Retinopathy, aiming to treat the full spectrum of diabetic retinal disease, including patients with or without DME [418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440] - The HELIOS-1 study showed a 231% 2-step DRSS improvement in the AXPAXLI arm at Week 48 compared to 0% in the sham arm [397, 398, 399]

Core Points - Ocular Therapeutix, Inc. announced an underwritten offering of 37,909,018 shares of common stock at a price of $12.53 per share, aiming for gross proceeds of approximately $475.0 million [1] - The offering is expected to close on or about October 1, 2025, pending customary closing conditions [1] Use of Proceeds - The net proceeds from the offering will be used to fund an open-label extension study for AXPAXLI™ in patients with wet age-related macular degeneration (wet AMD) [3] - Funds will also support Phase 3 clinical trials of AXPAXLI for treating non-proliferative diabetic retinopathy (NPDR), infrastructure investments, pre-commercialization activities, and general corporate purposes [3] Offering Details - The offering is conducted under an automatically effective shelf registration statement on Form S-3 filed with the SEC [4] - Joint book-running managers for the offering include BofA Securities, TD Cowen, and Piper Sandler & Co., with Baird and Raymond James as lead managers [2] Company Overview - Ocular Therapeutix is focused on redefining the retina experience and has an investigational product candidate, AXPAXLI, currently in Phase 3 trials for wet AMD and NPDR [6] - The company also markets DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain, and is developing OTX-TIC for open-angle glaucoma [7]

Core Insights - Ocular Therapeutix is showcasing significant advancements in its clinical programs for AXPAXLI, particularly in wet AMD and diabetic retinopathy, during its Investor Day [1][2][3] - The company is on track to release topline data for the SOL-1 trial in Q1 2026 and for the SOL-R trial in H1 2027, with both trials demonstrating strong patient retention and adherence [1][3][5] Wet AMD Program Highlights - The SOL-1 trial has over 95% retention of randomized subjects and is designed to potentially support the first superiority label over aflibercept (2 mg) for wet AMD [3][4] - The SOL-R trial incorporates a comprehensive patient selection strategy to minimize variability in visual acuity, with topline data expected in H1 2027 [3][5][16] - AXPAXLI is positioned to optimize retina practices globally, allowing for less frequent patient visits and potentially improving treatment outcomes [2][6] Diabetic Retinopathy Program Highlights - Ocular plans to initiate two registrational trials, HELIOS-2 and HELIOS-3, for non-proliferative diabetic retinopathy (NPDR), targeting a broad treatment label [7][8] - HELIOS-2 will compare AXPAXLI to ranibizumab (0.3 mg) with a primary endpoint at Week 52, while HELIOS-3 will evaluate two dosing regimens of AXPAXLI against sham [8][9][24] - The trials will utilize a novel ordinal endpoint for assessing diabetic retinopathy severity, which is expected to enhance the probability of success and reduce trial size [9][24][25] AXPAXLI Overview - AXPAXLI (OTX-TKI) is an investigational bioresorbable hydrogel incorporating axitinib, aimed at treating wet AMD and diabetic retinopathy [10][33] - The product is currently in Phase 3 clinical trials, with a focus on improving long-term patient outcomes and reducing treatment burdens [10][33] Company Background - Ocular Therapeutix is committed to redefining the retina experience and has developed a pipeline that includes DEXTENZA, an FDA-approved corticosteroid for ocular conditions [32][34]

Company Overview - Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on developing sustained-release drug treatments for eye diseases using its ELUTYX hydrogel technology [3]. Analyst Insights - Daniil Gataulin from Chardan Capital initiated coverage on Ocular Therapeutix with a Buy rating and a price target of $21, indicating strong confidence in the company's future performance [1]. - The analyst emphasized the Axpaxli program, which is the company's lead initiative aimed at reducing the treatment burden for patients requiring frequent anti-VEGF injections, commonly used for conditions like wet age-related macular degeneration and non-proliferative diabetic retinopathy [2]. - Gataulin believes that Axpaxli has significant potential to enhance patient outcomes by decreasing the frequency of required treatments, positioning it as a valuable option in the eye care market [2]. - The gradual launch strategy for Axpaxli allows Ocular Therapeutix to effectively manage supply and uptake, which could further support its market position [2].

Summary of Ocular Therapeutix Conference Call Company Overview - Ocular Therapeutix is currently conducting two Phase III studies, SOL1 and SOLR, with expected data readouts in Q1 2026 and the first half of 2027 respectively [4][35] - The company recently announced a Special Protocol Assessment (SPA) for a study in nonproliferative diabetic retinopathy (NPDR) [4] Core Points and Arguments Study Updates - SOL1 aims for a superiority label, which is considered crucial for the company's valuation and market positioning [8][12] - The open-label extension study is designed to assess the long-term efficacy and safety of the treatment, with expectations that crossover patients will not catch up in terms of outcomes [13][14] - Changes to the rescue criteria for SOLR were made to simplify the study and align with regulatory expectations, ensuring data integrity remains intact [15][17][18] Market Positioning - The superiority label is seen as a "holy grail" that could differentiate Ocular's product from competitors, potentially allowing for premium pricing and market protection [8][12] - The company believes that the current anti-VEGF market is saturated with non-inferiority studies, and achieving a superiority label would place Ocular in a unique position [11][12] Regulatory Collaboration - Ocular has established a strong relationship with the FDA, allowing for significant modifications to study designs while preserving the SPA [34][46] - The company is aligned with European regulators and expects efficient filing processes upon achieving primary endpoints [18][47] Clinical Data and Expectations - The company is confident in the masked data from SOL1, indicating a favorable pattern of rescues and adherence to protocol [19][21] - A delta of 15% is required for statistical significance in the SOL1 study, with expectations that the study is overpowered for a 50% delta [26][27] Future Outlook - The market for wet AMD and NPDR is considered vast, with Ocular's product expected to redefine treatment paradigms [60] - The upcoming Investor Day on September 30 is anticipated to provide further insights into market size and the importance of the superiority label [58] Important but Overlooked Content - The company emphasizes the importance of patient selection in clinical trials, ensuring that only stable patients are included to minimize variability [40][42] - The potential for the drug to be used in a wide range of patients without requiring new equipment or workflow changes is highlighted as a significant advantage for adoption [52] - The company plans to discuss novel ideas regarding market size and opportunities at the upcoming Investor Day, suggesting that current market valuations may be underestimated [58]

Company Background - The company has recently undergone leadership changes, with the current Executive Chairman, President, and CEO having been in the role for just over a year [2] - The CEO had previously retired but was drawn back into the industry due to the potential of the company and its technology [2] Technology and Innovation - The company possesses the ELUTYX technology, which is recognized as a leading long-acting platform for treating geographic atrophy, a significant area of interest for the CEO based on prior experience [3] - Independent evaluations confirmed the superiority of the ELUTYX technology, reinforcing its potential in the market [3] Regulatory Pathway - The company has established a Special Protocol Assessment (SPA) with the FDA, providing a clear regulatory pathway that aligns with the latest guidelines issued in February 2023 [4] - This regulatory clarity is seen as a major advantage for the company, facilitating its development and market entry [4] Market Opportunity - The CEO emphasizes the clinical need for more durable treatments with better outcomes, indicating a strong market opportunity for the company's offerings [4]