Investing.com -- Ocular Therapeutix (NASDAQ:OCUL) shares fell 1% Wednesday following the company’s Investor Day, where it outlined plans to submit a New Drug Application for AXPAXLI in wet age-related macular degeneration in the fourth quarter of 2026.
The Bedford, Massachusetts-based biopharmaceutical company said it reached alignment with the U.S. FDA during a May 2026 Type C meeting to base the AXPAXLI NDA on SOL-1 Week 52 efficacy and safety data plus interim SOL-R safety data. The company plans to conduct an interim SOL-R safety analysis in the fourth quarter of 2026 to reach more than 300 patients of safety data across SOL-1 and SOL-R, in line with FDA requirements.
Ocular said SOL-R efficacy data is no longer part of the AXPAXLI NDA submission plan. The company will now evaluate superiority of AXPAXLI versus aflibercept (8mg) every six months at Week 96 as a key secondary endpoint of the SOL-R trial. SOL-R will remain masked through Week 96, with topline results now expected in the first quarter of 2028, compared to the previous timeline.
The company plans to submit its NDA under the 505(b)(2) pathway, which has the potential to accelerate the review timeline by up to 60 days, according to the announcement.
Ocular also said it is streamlining its diabetic retinopathy program to prioritize HELIOS-3 as a potential single registrational trial evaluating every 12 months dosing of AXPAXLI.
The SOL-1 trial completed randomization of 344 treatment-naïve subjects with wet AMD in December 2024. In February 2026, Ocular reported that 74.1% of subjects in the AXPAXLI arm maintained vision at Week 36, compared to the aflibercept arm, meeting the superiority primary endpoint with a p-value of 0.0006.
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