Key Takeaways

  • Ocular Therapeutix completed its pre-NDA meeting with the FDA for Axpaxli in wet AMD and remains on track for a fourth-quarter 2026 NDA submission
  • The application is expected to include Week 52 efficacy and safety data from phase 3 SOL-1, interim safety data from phase 3 SOL-R, and supporting confirmatory evidence
  • The planned 505(b)(2) submission will include patients who received multiple Axpaxli injections to support repeat dosing

Ocular Therapeutix announced the successful completion of a pre-New Drug Application (NDA) meeting with the FDA for Axpaxli (OTX-TKI), its investigational therapy for wet age-related macular degeneration (AMD), keeping the company on track for an NDA submission in the fourth quarter of 2026.

According to the company, expectations for the planned application remain consistent with previous FDA communications, including a Type C meeting held in May 2026. The NDA is expected to include 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.

Pravin U. Dugel, MD, executive chairman, president and CEO of Ocular Therapeutix, said the submission will include data from participants who received multiple Axpaxli injections to support the company’s proposed repeat-dosing approach.

Axpaxli is a bioresorbable intravitreal hydrogel incorporating axitinib, a small-molecule, multitarget tyrosine kinase inhibitor with antiangiogenic properties. The investigational therapy is being developed to provide sustained control of retinal vascular disease and is also being evaluated in diabetic retinal disease.

The regulatory update follows results from SOL-1, a registrational phase 3 superiority trial conducted under a Special Protocol Assessment agreement with the FDA. Ocular Therapeutix reported in February 2026 that SOL-1 met its prespecified primary endpoint with high statistical significance.

Following a Type C meeting in May, the company said FDA meeting minutes supported an NDA incorporating Week 52 efficacy and safety results from SOL-1, interim safety findings from SOL-R, and additional confirmatory evidence.

The September pre-NDA meeting further aligned the company and FDA on the planned application's content and format, according to Ocular Therapeutix. The company intends to submit Axpaxli under the 505(b)(2) regulatory pathway.

Ocular Therapeutix said it expects to conduct the interim SOL-R safety analysis before submitting the NDA in the fourth quarter.