Ocular Therapeutix Inc

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 announced its participation in several scientific and investor conferences in July 2026. At the OIS Retina Innovation Summit on July 14, Chief Development Officer Peter K. Kaiser will present on the company's retina experience, and Executive Chairman, President and CEO Pravin U. Dugel will moderate a panel on FDA guidance. At the ASRS 44th Annual Meeting from July 15 to 18, the company will present Phase 3 SOL-1 trial results for its investigational axitinib hydrogel OTX-TKI in wet AMD, along with real-world anti-VEGF treatment analyses and a symposium on redefining nAMD management. Additionally, Dugel will participate in a fireside chat at the HC Wainwright 6th Annual Ophthalmology Virtual Conference on July 22.

Ocular Therapeutix announced FDA alignment on its new drug application for AXPAXLI in wet age-related macular degeneration during an investor day event. The company reached agreement with the FDA to include safety data from the Phase 3 SOL-R trial in the NDA submission while excluding its efficacy data, following a Type C meeting. A pre-NDA meeting is expected in the third quarter of 2026, with a complete NDA package submission anticipated in the fourth quarter alongside an interim safety analysis for SOL-R. If approved, AXPAXLI could launch in 2027, with topline SOL-R efficacy data planned for early 2028. The drug is also being studied in diabetic retinopathy in the HELIOS-3 registrational trial.