Ocular Therapeutix has announced FDA-aligned plans to submit a New Drug Application for AXPAXLI in wet age-related macular degeneration (AMD) in the fourth quarter of 2026, based on Phase 3 SOL-1 efficacy and safety data and interim SOL-R safety data.

The company said the agreement followed a Type C meeting with the FDA in May 2026. Ocular plans to submit the application under the 505(b)(2) pathway, which it said could shorten the review timeline by up to 60 days.

AXPAXLI, also known as OTX-TKI, is an investigational bioresorbable intravitreal hydrogel incorporating axitinib, a tyrosine kinase inhibitor with anti-angiogenic properties. It is being developed for wet AMD and diabetic retinal disease.

Ocular said SOL-1 data will form the efficacy basis of the planned submission, while an interim SOL-R safety analysis in the fourth quarter of 2026 is expected to bring the safety dataset to more than 300 patients across SOL-1 and SOL-R. SOL-R efficacy data are no longer expected to form part of the planned NDA submission.

The company also plans to hold a pre-NDA meeting with the FDA in the third quarter of 2026 to confirm the format and content of the submission. If approved, Ocular said AXPAXLI could potentially reach patients in 2027.

Following the change in regulatory strategy, Ocular is amending SOL-R and keeping the trial masked through Week 96. Topline data are now expected in the first quarter of 2028. A new key secondary endpoint will evaluate whether AXPAXLI is superior to aflibercept 8 mg in mean change in BCVA at Week 96.

Ocular also said it is streamlining its diabetic retinopathy program to prioritize HELIOS-3 as a potential single global registrational trial evaluating once-yearly AXPAXLI against sham in non-proliferative diabetic retinopathy.

Pravin U. Dugel, Executive Chairman, President and CEO of Ocular Therapeutix, said the FDA-aligned plan marked a “pivotal milestone” for the company and reflected its aim to bring AXPAXLI to patients as quickly as possible while reducing regulatory risk.

“The data for AXPAXLI from SOL-1 showed unmatched durability and a level of sustained disease control that is simply unprecedented in this space,” he added. “Because of these outstanding data, and with SOL-R year one efficacy data no longer being part of our planned NDA submission, we are now in the extraordinary position of using the SOL-R trial to best serve our long-term strategic objective for AXPAXLI: to become the best-in-disease agent for wet AMD.”

Source: Ocular Therapeutix.