Aldeyra Therapeutics Says FDA Grants Fast Track Designation For ADX-2191 For Treatment Of Retinitis Pigmentosa

Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of retinitis pigmentosa. There is currently no approved treatment for patients with most forms of retinitis pigmentosa, a clinical group of rare genetic eye diseases characterized by retinal cell death and loss of vision. Retinitis pigmentosa affects more than one million people worldwide.

The potential activity of ADX-2191 in retinitis pigmentosa is supported by results from a Phase 2 clinical trial, announced in 2023, which demonstrated improvements from baseline in retinal sensitivity following treatment. A planned Phase 2/3 clinical trial of ADX-2191 in retinitis pigmentosa is expected to initiate in 2025.

Fast Track Designation is designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address an unmet medical need. Fast Track Designation enables frequent FDA interactions and may allow for rolling review, priority review, or accelerated approval if relevant criteria are met.