Axpaxli (intravitreal axitinib implant) / Ocular Therapeutix - LARVOL DELTA

Ocular Therapeutix Announces Positive Pre-NDA Meeting with U.S. FDA for AXPAXLI in Wet AMD (Yahoo Finance) - "Based on the Pre-NDA Meeting, the Company's expectations for the AXPAXLI NDA package remain consistent with prior FDA communications, including the May 2026 Type C Meeting. Ocular remains on track to submit the NDA in the fourth quarter of 2026...'Consistent with the FDA Type C Meeting minutes we previously communicated, our NDA submission will continue to be based on efficacy and safety data from SOL-1, interim safety data from SOL-R, and supporting confirmatory evidence.'"

FDA event • FDA filing • Wet Age-related Macular Degeneration

Ocular Therapeutix Reports Second Quarter 2026 Financial Results and Business Highlights (GlobeNewswire) - "Ocular’s AXPAXLI wet AMD NDA submission on track for Q4 2026 following positive Type C Meeting with the U.S. FDA in May 2026....Pre-NDA meeting scheduled with FDA in Q3 2026 with the NDA submission to follow the Section 505(b)(2) pathway which could accelerate the review timeline by up to 60 days....Commercial readiness accelerating ahead of a potential 2027 launch."

FDA event • FDA filing • Launch • Wet Age-related Macular Degeneration

Axpaxli: "Unmatched durability: First trial to demonstrate durability >9 months"; Wet age-related Macular Degeneration (Ocular Therapeutix) - ASRS 2026

P3 data • Ophthalmology • Wet Age-related Macular Degeneration

TKI axitinib beats anti-VEGF therapy in wet AMD in phase 3 trial | ASRS 2026 (Managed Healthcare Executive) - "In the trial, 74% of patients treated with axitinib maintained vision compared with 56% for the aflibercept 2 mg group at 36 weeks. This difference was maintained for 52 weeks at 66% for those treated with axitinib versus 44% treated with aflibercept, Dhoot said. The proportion of those who were rescue-free was also higher in the axitinib group. At 36 weeks, 74.7% of patients who had received axitinib were rescue-free compared with 56.4% treated with aflibercept. At 52 weeks, 68.8% of axitinib patients were rescue-free compared with 47.7% of aflibercept....Ocular Therapeutics plans to submit a new drug application for axitinib in wet AMD to the FDA in the fourth quarter of 2026 with the brand name Axpaxli."

FDA filing • P3 data • Wet Age-related Macular Degeneration

Ocular Therapeutix to Participate in July Scientific and Investor Conferences (Ocular Therapeutix Press Release) - "The American Society of Retina Specialists (ASRS) 44th Annual Meeting: July 15 - 18, 2026 Montréal, Quebec."

Clinical data • Age-related Macular Degeneration • Wet Age-related Macular Degeneration

Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study (clinicaltrials.gov) - P3 | N=850 | Recruiting | Sponsor: Ocular Therapeutix, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Wet Age-Related Macular Degeneration (wet AMD) Program Highlights (GlobeNewswire) - "...'we are well positioned to bring AXPAXLI to patients in 2027, if approved.'...FDA indicates it will review the NDA submission based on a single pivotal trial in light of results from SOL-1 at Week 52...To meet FDA requirements for safety exposure, Ocular plans to conduct an interim safety analysis for SOL-R in fourth quarter of 2026...Ocular plans to hold a pre-NDA meeting in third quarter of 2026 with U.S. FDA...At the standard 120-day safety update following the submission of its NDA, Ocular plans to submit Year 2 SOL-1 safety data to the FDA to support repeat dosing on a potential label for AXPAXLI...Because SOL-R efficacy is no longer part of the planned NDA submission or review, Ocular intends to leverage the trial to best serve its long-term strategic objectives for AXPAXLI. This includes maintaining masking of SOL-R to subjects, investigators, and the Company until Week 96 to evaluate new secondary endpoints, with topline data now expected in first quarter of 2028."

FDA event • FDA filing • Launch US • P3 data: top line • Wet Age-related Macular Degeneration

Diabetic Retinopathy (DR) Program Highlights (GlobeNewswire) - "Ocular announced plans to streamline its diabetic retinopathy (DR) program to prioritize a single global registrational superiority study, HELIOS-3...the Company plans to advance a streamlined superiority trial evaluating AXPAXLI Q12M versus sham....The Company expects the streamlined approach to preserve its ability to achieve global regulatory objectives and maximize the commercial opportunity for AXPAXLI in diabetic retinal disease. The trial is intended to support a broad DR label, including patients with non-center-involved diabetic macular edema (non-CI DME)."

Trial status • Diabetic Macular Edema • Diabetic Retinopathy

Recent Achievements and Upcoming Milestones (GlobeNewswire) - "AXPAXLI New Drug Application (NDA) submission for wet AMD remains on track based on the SOL-1 Week 52 trial results, subject to ongoing formal discussions with the U.S. FDA. Ocular plans to leverage the 505(b)(2) application pathway, which could potentially shorten the NDA review timeline for AXPAXLI by up to two months. The Company plans to provide regulatory updates during its Investor Day on June 17, 2026...SOL-R (Phase 3, wet AMD) non-inferiority trial remains on track for topline data in 1Q 2027...HELIOS-3 (Phase 3, NPDR) trial ongoing as Ocular plans to provide an update on its diabetic retinopathy program at June Investor Day....The Company also plans to provide an update on the ongoing SOL-R and SOL-X trials in wet AMD, and the commercialization strategy for AXPAXLI in wet AMD, if approved."

FDA filing • P3 data: top line • Trial status • Diabetic Retinopathy • Wet Age-related Macular Degeneration

Ocular Therapeutix…announced that the first patient has been enrolled in the SOL-X long-term extension trial for AXPAXLI (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD) (GlobeNewswire) - "The SOL-X open-label wet AMD extension trial is intended to evaluate the long-term safety of AXPAXLI and explore its ability to improve long-term outcomes. Subjects who have completed their two-year follow-up in either SOL-1 or SOL-R have an opportunity to enroll in the SOL-X study for an additional three years."

Trial status • Wet Age-related Macular Degeneration

Ocular Therapeutix Announces Additional Positive Week 52 Data from Landmark SOL-1 Phase 3 Trial of AXPAXLI in Wet AMD (GlobeNewswire) - "The median time to ≥30 uM Central Subfield Thickness (CSFT) increase from Week 8 was 39 weeks in the AXPAXLI group and 16 weeks in the aflibercept (2 mg) group, a 23-week difference. An estimated hazard ratio of 0.7 indicates that, at any time from Week 8 to Week 52, subjects in the treatment group experienced a 30% lower risk of the event (descriptive p=0.0028) compared with the control group. The median time to ≥75 uM CSFT increase from Week 8 was 46 weeks in the AXPAXLI group and 24 weeks in the aflibercept (2 mg) group, a 22-week difference."

P3 data • Wet Age-related Macular Degeneration

Ocular Therapeutix remains on track to submit its New Drug Application (NDA) for AXPAXLI in wet AMD based on the SOL-1 trial alone, subject to planned formal discussions with U.S. FDA (GlobeNewswire) - "This planned submission is consistent with recent FDA commentary, including a February 2026 New England Journal of Medicine editorial indicating that a single well-controlled Phase 3 trial is expected to become the new default standard for approval. In early-April, 2026, the FDA Commissioner further noted that this framework is anticipated to be phased in over the next six months, highlighting that the same statistical power can be achieved with a well-designed, well controlled, appropriately powered, single pivotal trial."

FDA event • FDA filing • Wet Age-related Macular Degeneration

Ocular Therapeutix to Present Additional SOL-1 Data and Analyses at Upcoming Scientific Conferences in April (Ocular Therapeutix Press Release) - "Ocular plans to present additional data and analyses from the SOL-1 Phase 3 superiority clinical trial of AXPAXLI (also known as OTX-TKI), for the treatment of wet age-related macular degeneration (wet AMD)."

P3 data • Wet Age-related Macular Degeneration

Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study (clinicaltrials.gov) - P3 | N=850 | Not yet recruiting | Sponsor: Ocular Therapeutix, Inc.

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ocular Therapeutix Reports Positive Results from Landmark SOL-1 Phase 3 Superiority Trial in Wet AMD (Ocular Therapeutix Press Release) - "65.9% of subjects treated with AXPAXLI maintained vision at Week 52, a 21.1% risk difference (p<0.0001), compared to aflibercept (2 mg) arm; Rescue-free rates in the AXPAXLI arm were 80.6%, 74.7%, and 68.8% at Weeks 24, 36, and 52; AXPAXLI met its primary endpoint at Week 36 with high statistical significance. The proportion of subjects with <15 ETDRS letters lost from baseline at Week 36 was 74.1% in the AXPAXLI arm compared to 55.8% in the aflibercept (2 mg) arm, with a risk difference of 17.5% and p-value of 0.0006 per the pre-specified statistical model, and with an observed difference of 18.3%."

P3 data: top line • Wet Age-related Macular Degeneration

Next Steps (Ocular Therapeutix Press Release) - "SOL-1 subjects remain masked and have received their second injection of their respective initial treatment at their Week 52 visit. Subjects will receive another injection of their respective initial treatment at Week 76 and will be followed on a masked-basis for safety until the end of Week 104...Ocular intends to submit a New Drug Application (NDA) based on SOL-1 data, subject to planned formal discussions with the U.S. FDA....The complementary SOL-R Phase 3 non-inferiority trial of AXPAXLI in wet AMD will continue as planned, with topline data expected in 1Q 2027."

FDA filing • P3 data: top line • Trial status • Wet Age-related Macular Degeneration

Ocular Therapeutix…announced that the Company will host a webcast to review the topline results of the SOL-1 Phase 3 superiority clinical trial of AXPAXLI (also known as OTX-TKI), for the treatment of wet age-related macular degeneration (wet AMD), on Tuesday, February 17, 2026 (GlobeNewswire) - "Detailed data will be presented at the 49th Macula Society Annual Meeting between February 25 – 28, 2026."

P3 data: top line • Wet Age-related Macular Degeneration

Ocular Q4 Revenue Declines; Phase 3 Wet AMD Trial Data Expected Later This Month (Nasdaq) - "Topline results from SOL-1, the company's Phase 3 superiority trial in wet AMD, remain masked but are expected to be presented at the 49th Macula Society Annual Meeting, taking place between February 25 - 28, 2026...With randomization exceeding the original target, Ocular now anticipates topline SOL-R data in 1Q 2027, earlier than previously expected. In addition, the SOL-X open-label extension trial is expected to begin in 2Q 2026, offering long-term safety and durability insights for patients completing SOL-1 or SOL-R."

Clinical data • New trial • Age-related Macular Degeneration • Wet Age-related Macular Degeneration

Ocular Therapeutix Achieves Target Randomization of 555 Subjects in SOL-R (GlobeNewswire) - "Ocular will continue to allow randomization of previously enrolled subjects currently in the loading phase of the trial to maintain its commitment to both patients and investigators, with topline data remaining on track for the first half of 2027."

Enrollment status • P3 data: top line • Wet Age-related Macular Degeneration

Ocular Therapeutix…announced Friday that it intends to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate AXPAXLI (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD) (Investing.com) - "The company plans to base the application on year 1 data from its ongoing SOL-1 Phase 3 clinical trial, according to a press release statement and a filing with the Securities and Exchange Commission....The company expects to report top-line data from the first year of the SOL-1 clinical trial during the first quarter of 2026."

FDA filing • P3 data: top line • Wet Age-related Macular Degeneration

Ocular Therapeutix Announces Plans to Accelerate NDA Submission Timeline for AXPAXLI in Wet AMD (The Manila Times) - "...the Company now intends to submit a New Drug Application (NDA) for AXPAXLI (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD) following year one data, if positive, from its ongoing SOL-1 Phase 3 clinical trial for which data are on track for the first quarter of 2026...The Company expects that additional data from the continuation of SOL-1 in year two, SOL-R, and SOL-X will help clinicians and payors appreciate the anticipated benefits of AXPAXLI's efficacy, safety, and durability, allowing them to seamlessly adopt AXPAXLI into clinical practice."

FDA filing • P3 data • Wet Age-related Macular Degeneration

Ocular Therapeutix Announces First Patient Randomized in HELIOS-3 Phase 3 Registrational Program for AXPAXLI in NPDR (GlobeNewswire) - "The registrational Phase 3 HELIOS-3 trial...will be the second superiority study of AXPAXLI in approximately 930 subjects with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME)."

Trial status • Diabetic Retinopathy

HELIOS-3: A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy (clinicaltrials.gov) - P3 | N=930 | Recruiting | Sponsor: Ocular Therapeutix, Inc.

New P3 trial • Diabetic Retinopathy • Retinal Disorders

Ocular Therapeutix to present at Clinical Trials at the Summit 2025 (Modern Retina) - "At the meeting, the company will participate in several discussions and presentations as they share their ongoing work in developing tyrosine kinase inhibitor (TKI) candidates for the treatment of several retinal diseases, including wet age-related macular degeneration (AMD) and diabetic retinopathy (DR)."

Clinical data • Diabetic Retinopathy • Wet Age-related Macular Degeneration

OTX-TKI-2023-AMD-303: Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration (clinicaltrials.gov) - P3 | N=825 | Active, not recruiting | Sponsor: Ocular Therapeutix, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration