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FDA Accepts for Priority Review Drug for Rare Retinal Cancer

If approved, ADX-2191 could be the first marketed drug specifically for patients with primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act date of June 21, 2023.

The FDA has accepted for priority review Aldeyra Therapeutic’s new drug application (NDA) for ADX-2191 (methotrexate) to treat patients with primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 21, 2023.

Primary vitreoretinal lymphoma is a rare, aggressive, and potentially fatal retinal cancer that is diagnosed in about 300 to 600 patients in the United States per year. The median survival for newly diagnosed patients is less than five years. No approved treatments are currently available, though injection of compounded methotrexate represents the current standard of care.