Ocular Therapeutix, Inc. (NASDAQ: OCUL) announced it has reached alignment with the U.S. Food and Drug Administration on plans to submit a New Drug Application for AXPAXLI in wet age-related macular degeneration during the fourth quarter of 2026, according to a press release issued June 17, 2026.

The NDA will be based on data from the SOL-1 Phase 3 trial at Week 52, combined with interim safety data from the ongoing SOL-R trial. The company said it plans to conduct an interim SOL-R safety analysis in the fourth quarter of 2026 to accumulate more than 300 patients of safety data across both trials, meeting FDA requirements. SOL-1 enrolled 170 subjects receiving AXPAXLI.

Ocular said it plans to submit the NDA under the 505(b)(2) regulatory pathway, which the company said can accelerate the FDA review timeline by up to 60 days compared to the standard pathway. A pre-NDA meeting with the FDA is planned for the third quarter of 2026.

SOL-R efficacy data will no longer be included in the planned NDA submission. Instead, Ocular said it will extend masking of the SOL-R trial through Week 96 to evaluate new secondary endpoints, including a comparison of AXPAXLI against aflibercept (8 mg) in mean change in best corrected visual acuity. Topline SOL-R results are now expected in the first quarter of 2028, later than previously anticipated.

The SOL-1 trial met its primary superiority endpoint, with 74.1% of AXPAXLI-treated subjects maintaining vision at Week 36, representing a 17.5% risk difference versus aflibercept (2 mg) with a p-value of 0.0006. A key secondary endpoint at Week 52 was also met.

Separately, Ocular announced it is streamlining its diabetic retinopathy program to focus on a single Phase 3 registrational trial, HELIOS-3, which evaluates AXPAXLI administered once every 12 months versus sham injection in patients with non-proliferative diabetic retinopathy. The trial's primary endpoint will be measured at Week 56.

AXPAXLI remains an investigational product and has not received FDA approval.