Business
Aldeyra Therapeutics Receives Fast Track Designation for ADX‑2191 for the Treatment of Retinitis Pigmentosa
LEXINGTON, Mass., August 19, 2025--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 pigment
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"LEXINGTON, Mass., August 19, 2025--(BUSINESS WIRE)--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.","length":568,"tagName":"p"},{"type":"text","content":""Although retinitis pigmentosa is a relentlessly progressive condition that has been recognized for decades as a significant cause of blindness, there are no approved therapies for most forms of the disease," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "Fast Track Designation in conjunction with the previously announced Orphan Drug Designation underscores the potential for ADX-2191 to address an unmet need in the field of ophthalmology and creates the framework for ADX-2191, if approved, to reach patients promptly."","length":562,"tagName":"p"},{"type":"text","content":"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.","length":326,"tagName":"p"},{"type":"text","content":"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.","length":394,"tagName":"p"},{"type":"text","content":"About ADX-2191","length":14,"tagName":"p"},{"type":"text","content":"ADX-2191 (methotrexate injection, USP) is a sterile, non-compounded intravitreal formulation of methotrexate for the potential treatment of specific rare retinal diseases, including primary vitreoretinal lymphoma and retinitis ...