Aldeyra Gets FDA Orphan Drug Designation For ADX-2191 To Treat Primary Vitreoretinal Lymphoma

(RTTNews) - The U.S. Food and Drug Administration has granted orphan drug designation to Aldeyra Therapeutics Inc. (ALDX) for ADX-2191 or methotrexate for intravitreal injection for the treatment of primary vitreoretinal lymphoma or PVRL.

The FDA's orphan drug designation program is designed to provide financial incentives to sponsors for developing drugs and biologics for rare diseases and conditions, in part defined as affecting fewer than 200,000 people in the United States.

ADX-2191 inhibits dihydrofolate reductase, an enzyme involved in cellular replication and activation. Methotrexate is the most commonly used intravitreal medication for the treatment of PVRL.

ADX-2191 was previously granted orphan drug status and fast track designation by the FDA for the prevention of proliferative vitreoretinopathy, a rare but serious sight-threatening retinal disease with no approved treatment.