Aldeyra Therapeutics Receives Orphan Designation from European Medicines Agency for ADX-2191 to Treat Rare Vitreoretinal Lymphoma
Aldeyra Therapeutics Inc. has announced that the European Medicines Agency $(EMA)$ has granted Orphan Designation for their drug ADX-2191, a methotrexate intravitreal injection, intended for the treatment of primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma. This designation is significant as it offers Aldeyra benefits such as reduced regulatory fees and up to 10 years of market exclusivity within the European Union for this rare and aggressive cancer affecting a small patient population. This follows a similar designation by the U.S. Food and Drug Administration, further advancing Aldeyra's retinal disease program.
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