First patient randomized into HELIOS-3, which along with HELIOS-2 form the basis of AXPAXLI’s registrational program in non-proliferative diabetic retinopathy (NPDR) HELIOS-2 and HELIOS-3 are global, complementary superiority trials using a novel ordinal diabetic retinopathy severity scale (DRSS) primary endpoint Targeting a broad diabetic retinopathy (DR) label by including patients with non-center-involved diabetic macular edema (non-CI-DME) BEDFORD, Mass., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Ocular Therape ...

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 is advancing its registrational trial SOL-R for AXPAXLI™ in wet age-related macular degeneration (wet AMD), achieving a randomization target of 555 subjects, with topline data expected in the first half of 2027 [1][2][4] - The SOL-1 and SOL-R trials are designed to complement each other, with SOL-1 focusing on demonstrating AXPAXLI's durability and SOL-R supporting its clinical adoption with predictable dosing [2][3][4] - AXPAXLI aims to address the unmet need for more durable therapies in wet AMD, potentially extending dosing intervals to every 6 to 12 months and improving long-term visual outcomes [4][5] 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 [13][14] - The company utilizes its proprietary ELUTYX™ technology in its product pipeline, including the FDA-approved DEXTENZA and the investigational OTX-TIC for glaucoma [14][13] Clinical Trial Details - The SOL-R trial is a Phase 3, multi-center, double-masked, randomized study comparing AXPAXLI dosed every 6 months to aflibercept dosed every 8 weeks in treatment-naïve wet AMD patients [6][8] - The primary endpoint of SOL-R is to demonstrate non-inferiority in mean change in best corrected visual acuity (BCVA) from baseline at Week 56, with a non-inferiority margin of -4.5 letters [8][2] - SOL-1 is a superiority study evaluating a single injection of AXPAXLI versus aflibercept, with topline data expected in Q1 2026 [9][11] 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][12] - Current anti-VEGF therapies have limitations, including treatment discontinuation rates of up to 40% within the first year, leading to disease progression [4][12]

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 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 Viewpoint - Ocular Therapeutix, Inc. is actively participating in several investor and scientific conferences in September 2025 to showcase its advancements in retinal therapies and engage with the investment community [1][2][3]. Upcoming Investor Conferences - Ocular Therapeutix will present at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, from 2:35 to 3:10 PM ET, with Dr. Pravin U. Dugel as the presenter [2]. - The company will also participate in the Baird 2025 Global Healthcare Conference on September 9, 2025, from 12:50 to 1:20 PM ET, again featuring Dr. Pravin U. Dugel [2]. - Live webcasts of these presentations will be available on the Ocular Therapeutix website, with replays archived for at least 30 days [2]. Upcoming Scientific Conferences - Ocular Therapeutix will present at the EURETINA Innovation Spotlight on September 3, 2025, in Paris, focusing on redefining the retina experience, with Dr. Peter K. Kaiser as the presenter [3]. - The company will also participate in the Ophthalmology Futures Forums Retina Forum on the same day, with Dr. Peter K. Kaiser presenting in two sessions [4][5]. - At the 25th EURETINA Congress from September 4-7, 2025, Ocular will host a symposium titled "Advancing Retinal Disease Treatment: Exploring OTX-TKI's Potential to Extend Treatment Durability" on September 6, 2025 [5]. Company Overview - Ocular Therapeutix is an integrated biopharmaceutical company 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 [8]. - 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 its investigational product OTX-TIC, currently in Phase 2 trials for open-angle glaucoma [9].

Core Insights - Ocular Therapeutix has received FDA agreement on the registrational trial design for AXPAXLI targeting non-proliferative diabetic retinopathy (NPDR) [1][2] - The company plans to present its clinical trial design and development strategy for NPDR and diabetic macular edema (DME) at an Investor Day on September 30, 2025 [1][2] Company Overview - Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience with its investigational product AXPAXLI, a bioresorbable intravitreal hydrogel incorporating axitinib [3][8] - AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and is being evaluated for diabetic retinopathy and DME [8] Market Opportunity - Diabetic retinopathy affects nearly 9 million people in the U.S., with a significant portion of patients not receiving treatment despite the availability of effective therapies [2][6] - The potential for AXPAXLI to provide annual dosing could transform treatment approaches, shifting from reactive to proactive disease management [2][6] Clinical Trial Insights - In the Phase 1 HELIOS trial, AXPAXLI demonstrated no disease progression or vision-threatening complications in NPDR patients at 48 weeks, compared to 25% worsening in the control group [2][6] - The treatment showed improvement in all patients with non-center involved DME, indicating its potential to reshape proactive care in diabetic eye disease [2][6] Public Health Impact - With 6.4 million Americans living with NPDR and fewer than 1% currently treated, AXPAXLI's long-acting treatment could significantly reduce vision-threatening complications from diabetes [2][6][7]

Core Viewpoint - Ocular Therapeutix reported a significant widening of net loss in Q2 2025 due to increased research and marketing investments, alongside a decline in commercial revenue from its only marketed product, DEXTENZA [1][5][6] Financial Performance - Revenue (GAAP) for Q2 2025 was $13.5 million, slightly above expectations of $13.46 million, but down 18.1% from $16.4 million in Q2 2024 [2][5] - Net loss per share (GAAP) was $(0.39), missing analyst estimates by 8.4% and representing a 50% increase from $(0.26) in Q2 2024 [2][5] - Research and Development (R&D) expenses rose 76.9% to $51.1 million, driven by costs associated with two major Phase 3 trials [2][6] - Selling and Marketing expenses increased 37% to $13.7 million, reflecting pre-commercialization activities for AXPAXLI [2][6] - Cash and cash equivalents stood at $391.1 million as of June 30, 2025, with management indicating this provides a runway into 2028 [2][9] Product and Market Overview - DEXTENZA, the company's FDA-approved ocular implant, faced reimbursement challenges, leading to an 18.1% decline in net revenue despite a 5% increase in unit sales [5][8] - The company is focusing on advancing late-stage clinical trials for AXPAXLI, an ocular implant targeting wet age-related macular degeneration (AMD) [4][7] Clinical Development - The SOL-1 and SOL-R trials for AXPAXLI are progressing on schedule, with topline data from SOL-1 expected in Q1 2026 and primary endpoint data from SOL-R anticipated in the first half of 2027 [7] - Positive feedback was received from the FDA regarding potential designs for future studies in non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME) [7] Strategic Focus and Future Outlook - The company did not provide specific financial guidance for the upcoming quarter but emphasized the importance of advancing AXPAXLI's pivotal trials and maintaining cash reserves [10][11] - Future performance will depend on managing DEXTENZA's reimbursement pressures and executing late-stage clinical programs [11]

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]