Ocular Therapeutix has the FDA’s agreement on how to file AXPAXLI, its experimental treatment for wet age-related macular degeneration. The application is due in the fourth quarter of 2026.
The agreement came out of a Type C meeting with the agency in May 2026. The filing will rest on efficacy and safety results from the Phase 3 SOL-1 trial, plus an interim safety analysis from a second trial, SOL-R, in the fourth quarter. That analysis is expected to bring the safety dataset to more than 300 patients across the two studies. SOL-R efficacy data will not be part of the package.
Ocular plans to file under the 505(b)(2) pathway, which it says could shorten the review by up to 60 days. A pre-NDA meeting with the FDA is planned for the third quarter of 2026 to confirm the format and content of the submission. If the drug is approved, the company said it could potentially reach patients in 2027.
SOL-R changes course
Because SOL-R no longer has to supply the efficacy case, Ocular is amending it. The trial will stay masked through Week 96, with topline data now expected in the first quarter of 2028. A new key secondary endpoint will test whether AXPAXLI beats aflibercept 8 mg on mean change in best corrected visual acuity at Week 96.
AXPAXLI, also called OTX-TKI, is an investigational bioresorbable hydrogel placed inside the eye that incorporates axitinib, a tyrosine kinase inhibitor with anti-angiogenic properties. Ocular is developing it for wet AMD and for diabetic retinal disease.
On the diabetic side, the company is streamlining its program around HELIOS-3, which could serve as a single global registrational trial. It will compare once-yearly AXPAXLI against sham in non-proliferative diabetic retinopathy.
Pravin U. Dugel, the company’s executive chairman, president and CEO, called the plan a “pivotal milestone” and said it reflects the aim of bringing AXPAXLI to patients as quickly as possible while reducing regulatory risk. SOL-1, he said, “showed unmatched durability and a level of sustained disease control that is simply unprecedented in this space.” With year-one SOL-R efficacy out of the filing, he added, Ocular is “in the extraordinary position of using the SOL-R trial” to pursue its long-term goal for AXPAXLI: to become the best-in-disease agent for wet AMD.
