BEDFORD, Mass., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that the Company will participate in several upcoming investor conferences in March 2026. TD Cowen 46th Annual Health Care Conference:Date: Monday, March 2, 2026Fireside Chat: 9:10 – 9:40 AM ETPresenter: Pravin U. Dugel, MD, Executive Chairman, President and CEOLocation: Boston, MA Jefferies Biotech on the ...

Ocular to present detailed SOL-1 data at the 49th Macula Society Annual Meeting on Friday, February 27, 2026, starting at 1:00 PM PT (4:00 PM ET) Company to host an investor webcast on Monday, March 2, 2026, at 7:30 AM ET to discuss the Macula Society presentations BEDFORD, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that the Company will present detailed re ...

Core Insights - AXPAXLI has demonstrated superiority over aflibercept in a Phase 3 trial for wet AMD, achieving significant visual acuity maintenance at both Week 36 and Week 52 [1][2][3] Group 1: Trial Results - The primary endpoint was met with 74.1% of subjects in the AXPAXLI arm maintaining vision at Week 36, showing a 17.5% risk difference (p=0.0006) compared to aflibercept [1][7] - At Week 52, 65.9% of subjects treated with AXPAXLI maintained vision, with a 21.1% risk difference (p<0.0001) compared to aflibercept [1][9] - Rescue-free rates for AXPAXLI were 80.6%, 74.7%, and 68.8% at Weeks 24, 36, and 52, respectively, compared to 72.1%, 56.4%, and 47.7% for aflibercept [1][11] Group 2: Safety Profile - AXPAXLI was generally well-tolerated with no treatment-related ocular serious adverse events (SAEs) reported [5][19] - The safety profile included a lower incidence of ocular adverse events compared to aflibercept, with only one SAE in the AXPAXLI arm [5][38] Group 3: Future Plans - The company plans to submit a New Drug Application (NDA) based on the SOL-1 data, pending discussions with the U.S. FDA [2][19] - Detailed results will be presented at the 49th Macula Society Annual Meeting scheduled for February 25-28, 2026 [16][20] Group 4: Mechanism and Technology - AXPAXLI is a bioresorbable intravitreal hydrogel incorporating axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic properties [21][30] - The trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA, aiming for a superiority label for AXPAXLI in wet AMD [4][25] Group 5: Market Context - Wet AMD is a leading cause of severe vision loss, affecting approximately 14.8 million individuals globally, with current therapies facing challenges such as treatment burden and patient discontinuation [29] - AXPAXLI's potential to reduce treatment burden and improve long-term visual outcomes could lead to significant clinical adoption if approved [3][4]

Core Insights - Ocular Therapeutix will host a webcast on February 17, 2026, to review topline results from the SOL-1 Phase 3 clinical trial of AXPAXLI™ for wet age-related macular degeneration [1] - Detailed data from the trial will be presented at the 49 Macula Society Annual Meeting from February 25 to 28, 2026 [1] Company Overview - Ocular Therapeutix, Inc. is an integrated biopharmaceutical company focused on redefining the retina experience [3] - AXPAXLI™ (OTX-TKI) is an investigational product candidate for retinal diseases, currently in Phase 3 trials for wet AMD and diabetic retinal disease [3] - The company utilizes its proprietary ELUTYX™ technology in its commercial product DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain [4] Product Pipeline - DEXTENZA is approved for treating ocular inflammation and pain post-surgery and allergic conjunctivitis in patients aged two years or older [4] - Ocular is also developing OTX-TIC, a travoprost intracamreal hydrogel that has completed Phase 2 trials for open-angle glaucoma or ocular hypertension [4]

Core Insights - Ocular Therapeutix is preparing to present topline results from the SOL-1 Phase 3 superiority trial for AXPAXLI™ in wet AMD at the 49 Macula Society Annual Meeting scheduled for February 25-28, 2026 [1][3] - The company plans to submit a New Drug Application (NDA) for AXPAXLI based on the SOL-1 52-week data, contingent on positive results and discussions with the FDA [1][3] - The SOL-R Phase 3 non-inferiority trial has completed randomization of 631 subjects, with topline results expected in Q1 2027 [1][3] - Ocular has a cash balance of $737.1 million as of December 31, 2025, which is projected to support operations into 2028 [1][5] Business Highlights - The SOL-1 trial is designed to evaluate the safety and efficacy of AXPAXLI in treating wet AMD, with a primary endpoint focused on maintaining visual acuity [3][16] - The SOL-R trial aims to demonstrate non-inferiority compared to aflibercept, with a primary endpoint at Week 56 [3][19] - The HELIOS-3 trial for diabetic retinopathy is currently underway, with a focus on subjects with moderately severe to severe non-proliferative diabetic retinopathy [4][24] Financial Performance - Total net revenue for Q4 2025 was $13.3 million, a decrease of 22.4% from $17.1 million in Q4 2024 [6] - For the full year 2025, total net revenue was $52.0 million, down 18.5% from $63.7 million in 2024 [6] - Research and development expenses increased to $50.8 million in Q4 2025 from $41.0 million in Q4 2024, reflecting ongoing clinical trial costs [7] - The company reported a net loss of $(64.7) million for Q4 2025, consistent with a net loss of $(48.4) million in Q4 2024 [10] Future Developments - The SOL-X open-label extension trial is expected to begin in Q2 2026, allowing subjects from SOL-1 and SOL-R to enroll for additional safety follow-up [3][21] - The company raised approximately $475 million from an equity offering in September 2025, with net proceeds supporting operations into 2028 [4]

Core Insights - Ocular Therapeutix has appointed David W. Robinson as Global Chief Commercial Officer, which is expected to enhance the company's strategic positioning for the global launch of AXPAXLI™ for wet age-related macular degeneration and non-proliferative diabetic retinopathy, pending approval [1][2][3] Company Overview - Ocular Therapeutix, Inc. is an integrated biopharmaceutical company focused on redefining the retina experience with its investigational product candidate AXPAXLI™ (OTX-TKI), currently in Phase 3 clinical trials for wet AMD and NPDR [8] - The company also markets DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain, and is developing OTX-TIC, a travoprost intracamreal hydrogel for glaucoma [9] Leadership and Experience - David W. Robinson has a strong background in ophthalmology, having previously served as Chief Marketing Officer at Merck and played a key role in the launch of EYLEA at Regeneron, which is recognized as a significant success in the retina market [2][4][5] - Robinson's experience includes strategic launch planning, global market access, and building commercial teams, which will be crucial for Ocular's upcoming product launches [3][5] Product Potential - AXPAXLI is viewed as having global potential, with opportunities to improve patient outcomes and streamline logistics for healthcare providers, while also offering a predictable profile for payors [3] - The product candidate is positioned to address significant unmet needs in retinal diseases, with registrational programs already in progress [3][8]

Core Insights - Ocular Therapeutix plans to submit a New Drug Application (NDA) for AXPAXLI for wet age-related macular degeneration (wet AMD) following positive year one data from the SOL-1 Phase 3 clinical trial, expected in Q1 2026 [1][2] - AXPAXLI could be the first tyrosine kinase inhibitor (TKI) approved for wet AMD, potentially offering best-in-class durability and a superiority label [1][2] - The company aims to utilize the 505(b)(2) regulatory pathway to expedite the review process for AXPAXLI [1][2] Company Overview - Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience, with AXPAXLI being a key investigational product for retinal diseases [10] - The company has developed AXPAXLI as a bioresorbable intravitreal hydrogel incorporating axitinib, which has anti-angiogenic properties [5][10] Clinical Trial Details - The SOL-1 trial is a registrational Phase 3 study designed to evaluate the safety and efficacy of AXPAXLI, involving over 100 clinical trial sites in the U.S. and Argentina, with 344 treatment-naïve subjects randomized [6][8] - The primary endpoint of the SOL-1 trial is the proportion of subjects maintaining visual acuity at Week 36, with evaluations for durability extending to Week 52 [8] Market Context - Wet AMD is a leading cause of blindness, affecting approximately 14.5 million individuals globally and 1.8 million in the U.S., with many patients requiring frequent injections [4][9] - Current anti-VEGF therapies often lead to treatment discontinuation rates of up to 40% within the first year, highlighting the need for therapies with longer dosing intervals [4][9] Potential Impact - AXPAXLI aims to extend dosing intervals to every 6 to 12 months, potentially improving treatment adherence and long-term visual outcomes without altering current treatment procedures [3][4] - If successful, AXPAXLI could significantly reduce treatment discontinuation and redefine the treatment landscape for wet AMD [3][4]

Core Insights - The initiation of the HELIOS registrational program represents a significant advancement in the treatment of diabetic retinal disease, with AXPAXLI potentially addressing the needs of over 6 million NPDR patients in the U.S. who currently receive minimal therapy due to treatment burdens [2][3] - The HELIOS-2 and HELIOS-3 trials are designed to evaluate the efficacy of AXPAXLI in treating non-proliferative diabetic retinopathy (NPDR) and aim for a broad diabetic retinopathy label, including patients with non-center-involved diabetic macular edema (non-CI-DME) [2][3][12] - AXPAXLI is expected to provide durable efficacy with less frequent dosing, which could significantly improve patient adherence and outcomes compared to current treatment options that require frequent injections [2][3][12] Company Overview - Ocular Therapeutix, Inc. is an integrated biopharmaceutical company focused on redefining the retina experience through innovative treatments for retinal diseases, including AXPAXLI, which is currently in Phase 3 clinical trials for wet AMD and NPDR [14][15] - AXPAXLI is a bioresorbable intravitreal hydrogel that incorporates axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic properties, aimed at treating various retinal diseases [4][5] HELIOS Program Details - The HELIOS program consists of two complementary superiority studies: HELIOS-2 and HELIOS-3, which will assess the safety and efficacy of AXPAXLI in approximately 432 and 930 subjects, respectively, with moderately severe to severe NPDR [6][9] - Both studies utilize a novel ordinal diabetic retinopathy severity score (DRSS) as the primary endpoint, focusing on changes in severity at Week 52 from baseline [8][11] - HELIOS-2 compares AXPAXLI dosed every 12 months to ranibizumab, while HELIOS-3 evaluates different dosing regimens of AXPAXLI against sham treatment [7][10] Industry Context - Diabetic retinopathy is a prevalent condition affecting over 103 million people globally, with a significant portion of NPDR patients remaining untreated due to the burdensome nature of existing therapies [12][13] - The HELIOS trials aim to address the unmet need for effective treatments with durable efficacy, potentially transforming care for diabetic retinal disease and improving patient outcomes [3][12]

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]