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Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Dry Eye Disease
Additional Trial Required to Demonstrate Positive Effect on the Treatment of Ocular Symptoms in Dry Eye Disease Special Protocol Assessment Submitted on
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nAdditional Trial Required to Demonstrate Positive Effect on the Treatment of Ocular Symptoms in Dry Eye Disease\n\n\n\nSpecial Protocol Assessment Submitted on November 16, 2023 for Dry Eye Disease Chamber Crossover Clinical Trial\n\n\n\nProposed Trial Top-Line Results and Potential NDA Resubmission Anticipated in First Half of 2024\n\n\n\nCash Runway Extended into Late 2025\n\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. Although no safety or manufacturing issues with reproxalap were identified, the FDA stated in the letter that the NDA did not demonstrate “efficacy in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” should be conducted.\n\n\nPer draft FDA dry eye disease guidance, efficacy in dry eye disease may be demonstrated with two symptom trials and two sign trials. Among other clinical trials, Aldeyra previously conducted two trials for ocular redness (a dry eye disease sign) as well as a dry eye disease symptom trial. On November 16, 2023, Aldeyra submitted to the FDA a Special Protocol Assessment (SPA) for a dry eye disease chamber crossover clinical trial (the proposed trial) similar to the crossover chamber trial from which Aldeyra announced results on July 12, 2022. The SPA review cycle is anticipated to be 45 days, and Aldeyra expects FDA feedback from the SPA in December of 2023. The proposed trial is expected to cost less than $2 million, and top-line results are anticipated in the first half of 2024, subject to FDA feedback on the SPA.\n\n\nThe potential NDA resubmission is anticipated in the first half of 2024, pending FDA SPA feedback and positive results from the proposed trial. Aldeyra intends to include in the potential NDA resubmission a draft label describing chronic and acute symptomatic benefit, in addition to acute reduction in ocular redness of reproxa...