Aldeyra Therapeutics announced on August 28, 2025, that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191. This designation is for the treatment of primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma (PVRL). This is a significant regulatory milestone for the investigational drug in Europe.
Primary vitreoretinal lymphoma is a rare, aggressive, high-grade cancer for which there is currently no approved treatment. The EMA's Orphan Designation highlights the importance of developing new therapeutic options for patients suffering from this severe condition. This designation follows a previous FDA Orphan Drug Designation for ADX-2191 in PVRL.
The Orphan Designation provides Aldeyra with several benefits, including reduced regulatory fees, clinical protocol assistance, research grants, and up to 10 years of market exclusivity in the European Union upon approval. This support is crucial for advancing ADX-2191, a novel formulation of intravitreal methotrexate, through development and towards potential commercialization for this unmet medical need.
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