Ocular Therapeutix announced on September 15 that it completed a positive Pre-NDA Meeting with the US FDA for AXPAXLI, its investigational treatment for wet age-related macular degeneration, keeping the NDA on track for submission in the fourth quarter of 2026. The filing will include Week 52 efficacy and safety data from the Phase 3 SOL-1 trial, interim data from the ongoing SOL-R trial, and supporting confirmatory evidence, and will use the 505(b)(2) pathway, which could shave up to 60 days off the standard review timeline for a new molecular entity. In SOL-1, 74.1% of AXPAXLI patients maintained vision at Week 36, a 17.5 percentage point advantage over a single aflibercept injection that widened to 21.1 points by Week 52, and a post-hoc analysis showed AXPAXLI patients required up to 72% fewer injections over 60 weeks. If approved, AXPAXLI would become the first TKI approved for wet AMD, a market affecting 1.8 million Americans and 14.8 million individuals globally, with commercial preparation already accelerating ahead of a potential 2027 launch. Ocular's net losses widened to $78.8 million in the second quarter of 2026 from $67.8 million a year prior, while revenue stayed essentially flat at $13.5 million, and short interest sits at an elevated 15.08% of the float as of September 22.
Ocular Therapeutix IncPositive FDA Pre-NDA Meeting keeps AXPAXLI's NDA on track for Q4 2026 submission using the 505(b)(2) pathway
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