Aldeyra Therapeutics Inc. has announced that the European Medicines Agency $(EMA)$ has granted Orphan Designation for ADX-2191, their methotrexate intravitreal injection, for the treatment of inherited retinal dystrophies including retinitis pigmentosa. This regulatory milestone underscores the crucial need for effective treatments for retinitis pigmentosa, a rare genetic eye disease that affects over one million people globally. Orphan Designation by the EMA provides Aldeyra with benefits such as reduced regulatory fees and up to 10 years of market exclusivity within the European Union, aiding in the continued development and potential future availability of ADX-2191. This follows a similar Orphan Drug Designation from the U.S. FDA, highlighting the international recognition of the treatment's potential.
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