Aldeyra Therapeutics announced that the US Food and Drug Administration (FDA) has granted fast track designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of retinitis pigmentosa.

According to a company press release, the potential activity of ADX-2191 in retinitis pigmentosa is supported by results from a phase 2 clinical trial, reported 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, the company said. 

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.