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Aldeyra Therapeutics Says EMA Grants Orphan Drug Designation for Eye Disease Drug
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Aldeyra Therapeutics Says EMA Grants Orphan Drug Designation for Eye Disease Drug
Aug 28, 2025 5:19 AM

07:52 AM EDT, 08/28/2025 (MT Newswires) -- Aldeyra Therapeutics ( ALDX ) said Thursday that the European Medicines Agency has granted orphan drug designation to its experimental treatment, ADX-2191, for treating rare types of eye diseases.

The company said it plans to begin a clinical trial in the second half of 2025 under a Special Protocol Assessment agreement with the US Food and Drug Administration.

Orphan designation in the EU provides benefits such as reduced regulatory fees, clinical development support, and up to 10 years of market exclusivity, it added.

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