Material Event (Form 8-K)

Item 8.01. Other Events.

On September 30, 2025, Ocular Therapeutix, Inc., or the Company, announced certain updates regarding its development programs for AXPAXLI (also known as OTX-TKI), the Company's investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties. The Company is currently evaluating AXPAXLI for the treatment of wet age-related macular degeneration, or wet AMD, and plans to evaluate AXPAXLI for the treatment of non-proliferative diabetic retinopathy, or NPDR.

Update on wet AMD Program

SOL-1 Clinical Trial

The Company is currently conducting a repeat-dosing registrational Phase 3 clinical trial, which the Company refers to as the SOL-1 trial, to assess the safety and efficacy of AXPAXLI in subjects with wet AMD. The SOL-1 trial is designed as a prospective, multi-center, double-masked, randomized (1:1), parallel-group, two-arm superiority trial comparing a single injection of AXPAXLI 450 µg to a single injection of aflibercept 2 mg.

The SOL-1 trial completed the randomization of 344 subjects with a diagnosis of active macular choroidal neovascularization at screening in December 2024. Under the trial protocol, subjects were eligible for enrollment in the SOL-1 trial if they were treatment-naïve for wet AMD in the study eye; had central subfield thickness, or CSFT, of less than or equal to 500 microns; and had a Best Corrected Visual Acuity, or BCVA, of at least 54 letters as measured by the Early Treatment of Diabetic Retinopathy Study, or ETDRS, letters chart (approximately 20/80 Snellen equivalent vision). After screening, enrolled subjects received two aflibercept 2 mg loading doses at Weeks -8 and -4. Subjects reaching either a BCVA of greater than or equal to 84 ETDRS letters (approximately 20/20 Snellen equivalent vision) or experiencing an improvement of at least 10 ETDRS letters with a reduction in CSFT to no greater than 350 microns after these injections were randomized in the trial.

The primary endpoint of the SOL-1 trial is the proportion of subjects who maintain visual acuity, defined as a loss of fewer than 15 ETDRS letters from baseline, at Week 36. One of the secondary endpoints being evaluated is the proportion of subjects who maintain visual acuity measured at Week 52. At Weeks 52 and 76, all subjects that were randomized in the trial at Day 1, including subjects who previously received supplemental anti-VEGF treatment, are re-dosed with their respective initial treatment of a single injection of AXPAXLI 450 µg in the investigational arm or a single injection of aflibercept 2 mg in the control arm. Subjects will be followed for safety until the end of Year 2.

Retention in the trial continues to exceed greater than 95% of randomized subjects remaining on-trial to date, and rescues reviewed under masking suggest greater than 95% of rescue events to date have met pre-established protocol-defined criteria. To date, no new or unexpected safety signals have been observed for AXPAXLI in the SOL-1 trial, for which safety is monitored through an independent data safety monitoring committee.

The Company is conducting the SOL-1 trial in accordance with a special protocol assessment, or SPA, agreement with the U.S. Food and Drug Administration, or FDA. The Company continues to expect topline results for the SOL-1 trial to be available in the first quarter of 2026 after the completion of the Week 52 visits for all subjects in the trial.

SOL-R Clinical Trial

The Company is also conducting a repeat-dosing registrational Phase 3 clinical trial, which the Company refers to as the SOL-R trial, to evaluate the non-inferiority of AXPAXLI 450 µg dosed every 24 weeks for the treatment of wet AMD compared to aflibercept 2 mg dosed on-label every eight weeks. The SOL-R trial is designed as a multi-center, double-masked, randomized (2:2:1), three-arm trial and is expected to randomize approximately 555 subjects that are either treatment naïve or have been diagnosed with wet AMD in the study eye within about four months prior to enrollment. To qualify for screening in the SOL-R trial, subjects must have a BCVA of at least 34 ETDRS letters (approximately 20/200 Snellen equivalent vision).