Aldeyra Therapeutics announced on August 19, 2025, that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ADX-2191. This designation is for the treatment of retinitis pigmentosa, a group of rare genetic eye diseases that lead to retinal cell death and loss of vision. This marks a significant regulatory advancement for the investigational drug.
Retinitis pigmentosa is a relentlessly progressive condition with no approved therapies for most forms of the disease, affecting over one million people globally. The Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious or life-threatening conditions and address unmet medical needs. This can lead to more frequent FDA interactions and potentially rolling review, priority review, or accelerated approval.
The potential activity of ADX-2191 in retinitis pigmentosa is supported by Phase 2 clinical trial results, 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, further advancing this program with the benefit of expedited regulatory pathways.
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