Home / Health / Ocular Therapeutix: AXPAXLI Path to FDA Clear
Ocular Therapeutix: AXPAXLI Path to FDA Clear
23 Jul
Summary
- AXPAXLI submission for wet AMD planned for Q4.
- FDA agrees Ocular's data package is complete.
- Company confident in meeting evidentiary standards.
Ocular Therapeutix anticipates submitting its New Drug Application for AXPAXLI, a treatment for wet age-related macular degeneration, during the fourth quarter of 2026. This strategic move follows a significant alignment with the U.S. Food and Drug Administration concerning the proposed filing package.
Executive Chairman Dr. Pravin Dugel highlighted that this alignment is the culmination of extensive work and not a sudden shift in regulatory approach. He confirmed that the FDA has deemed the company's data "very compelling" and indicated acceptance of the package as a complete submission, while emphasizing that a full review by the FDA will follow.
The company believes it has met the necessary evidentiary standards for a single-trial approval pathway. This includes meeting pre-specified masking, statistical powering, and safety exposure requirements, as demonstrated in the SOL-1 trial conducted under a Special Protocol Assessment.
