Aldeyra receives FDA Fast Track Designation for ADX-2191 in retinitis pigmentosa

Aldeyra Therapeutics, Inc.

FDA granted Fast Track Designation for ADX-2191 (methotrexate intravitreal injection) for retinitis pigmentosa.
No approved therapy exists for most forms of retinitis pigmentosa, which affects over 1 million people worldwide.
Fast Track complements prior Orphan Drug Designation; may allow rolling review or priority/accelerated approval.
Phase 2/3 trial of ADX-2191 in retinitis pigmentosa expected to start in 2025.
Phase 2 results (2023) showed improvements from baseline in retinal sensitivity.

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