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]

Core Insights - Ocular Therapeutix is advancing its clinical trials for AXPAXLI, targeting wet age-related macular degeneration (AMD) with significant milestones expected in 2026 and 2027 [1][2][3] Clinical Trials and Development - SOL-1 trial is on track for topline data in Q1 2026, while SOL-R trial is expected to report topline data in H1 2027 [1][3] - A long-term extension study for both SOL trials is planned to follow patients after completion, aiming to gather additional safety and efficacy data [1][6] - SOL-R has streamlined rescue criteria to align with real-world clinical practices, enhancing its relevance and applicability [3][4] Financial Performance - As of June 30, 2025, the company reported a cash balance of $391.1 million, sufficient to support operations into 2028 [5][6] - Total net revenue for Q2 2025 was $13.5 million, an 18.1% decrease from $16.4 million in Q2 2024, attributed to a challenging reimbursement environment [7][8] - Research and development expenses increased to $51.1 million in Q2 2025, reflecting the costs associated with ongoing clinical trials [9] Strategic Initiatives - The company raised approximately $97 million in gross proceeds through an at-the-market facility in June 2025, enhancing financial flexibility [5][6] - An Investor Day is scheduled for September 30, 2025, to discuss the clinical strategy and commercial outlook for AXPAXLI [5][6] Market Context - Wet AMD affects approximately 14.5 million individuals globally, highlighting a significant market opportunity for innovative treatments like AXPAXLI [22] - Current therapies face challenges such as treatment burden and high patient discontinuation rates, indicating a need for more sustainable treatment options [22]

Core Insights - Ocular Therapeutix has successfully completed enrollment for the SOL-R trial, the largest retinal TKI trial to date, with a target randomization of at least 555 subjects [1][2][6] - The SOL-1 trial, which is complementary to SOL-R, completed randomization in December 2024 and is on track for top-line readout in Q1 2026 [1][2] - Both trials are designed to support a New Drug Application (NDA) submission for AXPAXLI in wet age-related macular degeneration (wet AMD) [1][3][4] Company Overview - Ocular Therapeutix is a fully-integrated biopharmaceutical company focused on redefining the retina experience [14] - AXPAXLI, the investigational product candidate, is a bioresorbable intravitreal hydrogel incorporating axitinib, aimed at treating wet AMD and other retinal diseases [5][14] - The company is leveraging its proprietary ELUTYX technology in both AXPAXLI and its commercial product DEXTENZA [15] Clinical Trials - The SOL-R trial is a Phase 3 registrational study evaluating the safety and efficacy of AXPAXLI, involving approximately 100 sites across the U.S., Argentina, India, and Australia [6][8] - The primary endpoint of SOL-R is to demonstrate non-inferiority in mean change in best corrected visual acuity (BCVA) compared to aflibercept at Week 56, with a non-inferiority margin of -4.5 letters [8][11] - The SOL-1 trial aims to evaluate the proportion of subjects maintaining visual acuity at Week 36, with a focus on durability up to Week 52 [11][9] Market Context - Wet AMD is a leading cause of blindness, affecting approximately 14.5 million individuals globally and 1.7 million in the U.S. [12][13] - Current treatments face challenges such as the need for frequent injections and high patient discontinuation rates, highlighting the need for more durable therapies [13] - AXPAXLI has the potential to significantly reduce treatment burden and improve long-term vision outcomes for patients with wet AMD [3][4]

2025 RBC Capital Markets Global Healthcare Conference, May 20, 2025 Fireside Chat Date: Tuesday, May 20, 2025 Fireside Chat Time: 2:35PM ET Presenter: Pravin U. Dugel, MD, Executive Chairman, President and CEO Location: New York, NY BEDFORD, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular"), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today announced participation in several upcoming investor conferences in the second ha ...

Company Participation in Investor Conferences - Ocular Therapeutix, Inc. will participate in the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, at 3:00 PM ET, with Dr. Pravin U. Dugel presenting [1] - The company will also host investor one-on-one meetings at the Piper Sandler Spring Biopharma Symposium on April 17, 2025, in Boston, MA [2] Product Pipeline and Technology - Ocular Therapeutix is focused on redefining the retina experience, with its product candidate AXPAXLI™ (axitinib intravitreal hydrogel) currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) [3] - The company utilizes its proprietary ELUTYX™ bioresorbable hydrogel-based formulation technology in its commercial product DEXTENZA®, which is FDA-approved for treating ocular inflammation and pain following surgery, as well as in PAXTRAVA™ (travoprost intracameral hydrogel), currently in Phase 2 clinical trials for open-angle glaucoma or ocular hypertension [4]