Ocular Therapeutix Inc. (OCLU), a biopharmaceutical company, on Thursday released updates on FDA alignments achieved for the new drug application (NDA) for AXPAXLI in treating wet Age-related Macular Degeneration (wet AMD). The data was presented at an Investors Day, hosted by the company.
Wet AMD is a leading cause of severe, irreversible vision loss, caused by abnormal new blood vessel growth and associated retinal vascularity in the macula. The condition affects about 14.8 people globally, with current treatments including pulsatile, intralocular injections that show varied and inconsistent levels of success.
AXPAXLI is an investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and diabetic retinal disease.
The Phase 3 SOL-1 trial was a multi-center, double-masked, randomized, parallel-group trial that completed dosing 344 patients of Wet AMD in 2024. Positive topline data from 52 weeks was reported by the company in 2026. The Phase 3 SOL-R trial was a similar study evaluating the drug on 631 subjects. Following a Type C trial with the FDA, an agreement was reached establishing the safety data as eligible for inclusion in a new drug application (NDA) submission, and the exclusion of the SOL-R efficacy data.
The NDA for AXPAXLI in treating wet AMD is planned for submission under the 505(b)(2) pathway, aligned through a special protocol assessment (SPA) agreement between the company and FDA.
A pre-NDA meeting is expected to be held with the FDA in the third quarter of 2026. This may be followed by an interim safety analysis for the SOL-R study in the fourth quarter, at which time a complete NDA package submission from the company is also anticipated.
If approved, the company believes that AXPAXLI may be launched in 2027. Topline data from the SOL-R trial is planned for release in the first quarter of 2028.
The company is also assessing AXPAXLI in the treatment of diabetic retinopathy in a single global registrational superiority study, HELIOS-3.
OCUL closed Thursday at $9.43, down 2.18%. In the pre-market, shares are trading at $9.22, down 2.23%.
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