AXPAXLI (OTX-TKI) - (SOL-1)

September 15, 2026: Ocular Therapeutix (NASDAQ: OCUL) said its Pre-NDA meeting with FDA confirmed plans to submit an NDA in 4Q 2026 for AXPAXLI (OTX-TKI) in wet age-related macular degeneration. The planned filing will rely on Week 52 efficacy and safety data from the Phase 3 SOL-1 trial, interim safety data from the ongoing Phase 3 SOL-R trial, and supporting confirmatory evidence; it will also include patients who received multiple AXPAXLI injections to support repeat dosing.

The company said this remains consistent with feedback from a May 2026 Type C meeting. SOL-1, conducted under an FDA Special Protocol Assessment, met its prespecified primary endpoint with high statistical significance in February 2026. Ocular said the September Pre-NDA meeting confirmed alignment with FDA on the content and format of the planned submission and that it expects to file via the 505(b)(2) pathway, which it says could shorten review by up to 60 days versus 505(b)(1).

Upcoming catalysts mentioned: interim SOL-R safety analysis and the AXPAXLI NDA submission, both targeted for 4Q 2026.