Ocular Therapeutix targets Q4 2026 AXPAXLI NDA filing for wet AMD after FDA meeting

Ocular Therapeutix said its planned New Drug Application for AXPAXLI (also known as OTX-TKI) in wet age-related macular degeneration remains on track for the fourth quarter of 2026¹, following a positive Type C Meeting with the U.S. FDA in May 2026¹. The company said the submission will rely on SOL-1 efficacy and safety data, an interim SOL-R safety analysis of patients reaching Week 52 conducted in the fourth quarter of 2026, and confirmatory evidence¹. Combined with existing SOL-1 data, the company said this interim SOL-R analysis will bring the aggregate safety data set to over 300 patients who have at least a year of exposure to AXPAXLI, which it said aligns with FDA expectations¹.

A pre-NDA meeting with the FDA is set for the third quarter of 2026, and Ocular said it plans to file under the 505(b)(2) pathway, which it believes could shorten the review clock by as much as 60 days¹.

The company also disclosed a new post-hoc analysis of SOL-1 showing an estimated reduction in treatment burden of up to 72% over 60 weeks with AXPAXLI compared with a projected on-label aflibercept (2 mg) regimen dosed every eight weeks¹.

SOL-R is being amended: Ocular said it will not need SOL-R efficacy data for the NDA and instead plans a new key secondary endpoint testing superiority to aflibercept 8 mg at Week 96, plus an endpoint on fibrosis and atrophy prevention¹, pushing topline SOL-R results to the first quarter of 2028¹. HELIOS-3 was also revised, moving to once-yearly (Q48W) dosing versus sham and cutting enrollment from 930 to 620 patients¹.

Financially, Ocular reported total cash and cash equivalents of $598.6 million as of June 30, 2026¹, which it said, together with anticipated DEXTENZA inflows, is sufficient to fund operations into 2028¹.