Ocular Therapeutix said it has completed a pre–New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) for Axpaxli (OTX-TKI), its investigational intravitreal axitinib hydrogel for neovascular age-related macular degeneration. The company remains on track to submit an NDA in the fourth quarter of 2026.

According to Ocular, the meeting confirmed alignment on the content and format of the planned application, consistent with guidance from a May 2026 Type C meeting. The company plans to seek approval through the 505(b)(2) pathway.

The proposed NDA will include 52-week efficacy and safety data from SOL-1, interim safety data from the ongoing phase 3 SOL-R trial, and supporting confirmatory evidence. It will also include data from patients who received multiple Axpaxli injections to support repeat dosing.

Conducted under a Special Protocol Assessment agreement with the FDA, SOL-1 met its prespecified primary endpoint in February 2026. Ocular described the trial as demonstrating superiority against an approved anti-VEGF therapy.

Axpaxli is a bioresorbable intravitreal hydrogel incorporating axitinib, a small-molecule, multitarget tyrosine kinase inhibitor. The therapy is also being studied in diabetic retinal disease.

Ocular said it expects to conduct an interim SOL-R safety analysis before submitting the NDA. RP