Company Participation in Investor Conferences - Ocular Therapeutix, Inc. will participate in several investor conferences in November and December 2025, including the Jefferies Global Healthcare Conference and the Piper Sandler 37th Annual Healthcare Conference [1][2] Leadership Presentation Details - Pravin U. Dugel, MD, Executive Chairman, President and CEO, will present at both conferences, with the Jefferies conference scheduled for November 18, 2025, and the Piper Sandler conference on December 3, 2025 [2] Product Pipeline and Clinical Trials - Ocular Therapeutix is focused on redefining the retina experience with its investigational product AXPAXLI™ (OTX-TKI), currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and planning to initiate a Phase 3 program for non-proliferative diabetic retinopathy (NPDR) imminently [3] - The company also leverages its proprietary ELUTYX™ technology in its commercial product DEXTENZA, an FDA-approved corticosteroid for treating ocular inflammation and pain, and in the investigational product OTX-TIC, which has completed a Phase 2 clinical trial for open-angle glaucoma or ocular hypertension [4]

Core Insights - Ocular Therapeutix is advancing its investigational product AXPAXLI™ for retinal diseases, with significant milestones achieved in clinical trials and a strong financial position to support ongoing and future studies [1][2][5] Clinical Development - The SOL-R trial for AXPAXLI in wet age-related macular degeneration (wet AMD) has successfully randomized 555 subjects, with topline data expected in the first half of 2027 [1][3] - The SOL-1 trial, also for wet AMD, is on track to report topline data in the first quarter of 2026, with over 95% retention of randomized subjects [3][4] - The HELIOS program for AXPAXLI in diabetic retinopathy (NPDR) is set to begin imminently, utilizing a novel primary endpoint agreed upon with the FDA [2][7] Financial Performance - As of September 30, 2025, the company reported a cash balance of $344.8 million, supplemented by approximately $445 million from a recent equity offering, providing a financial runway into 2028 [5][11] - Total net revenue for the third quarter of 2025 was $14.5 million, reflecting a 5.8% decrease from the same quarter in 2024, attributed to a challenging reimbursement environment [6][11] - Research and development expenses increased to $52.4 million in Q3 2025, driven by ongoing clinical trials and the SOL-X extension study [7][11] Market Opportunity - The annual market for anti-VEGF therapies is estimated at approximately $15 billion, with potential expansion opportunities in treating millions of undertreated wet AMD patients and the NPDR population, which is three times more prevalent than wet AMD [2][30] - The company aims to address the high discontinuation rates of current treatments, which can reach up to 40% within a year, by offering a more sustainable treatment option with AXPAXLI [30][31] Strategic Initiatives - The company is focused on enhancing its clinical trial designs and patient selection processes to increase the probability of success and align with real-world treatment goals [2][4] - Ocular Therapeutix plans to invest in infrastructure to support increased manufacturing capacity and future growth, leveraging its strong cash position [2][5]

Core Insights - Ocular Therapeutix, Inc. plans to host a conference call and webcast on November 4, 2025, to discuss recent business progress and financial results for Q3 2025 [1][2] Company Overview - Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience [3] - The company’s investigational product AXPAXLI™ (OTX-TKI) is in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and plans to initiate a Phase 3 program for non-proliferative diabetic retinopathy (NPDR) imminently [3] - Ocular's pipeline includes DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain, and OTX-TIC, an investigational product in Phase 2 for open-angle glaucoma or ocular hypertension [4]

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]