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Aldeyra Wins EMA Orphan Drug Status for ADX-2191 to Treat Rare Eye Cancer

Author: Benzinga Newsdesk | August 28, 2025 06:22am

Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma. There is currently no approved treatment for patients with primary vitreoretinal lymphoma, a rare, aggressive, high-grade cancer that affects approximately 100 to 200 people per year in the European Union.

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