Aldeyra Therapeutics – BiotechReality – Information Intelligence System for Biopharma

Aldeyra Therapeutics, Inc. (ALDX), a biotechnology company dedicated to discovering and developing innovative therapies to treat immune-mediated and metabolic diseases, today announced that it has received a Complete Response Letter from the United States Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) for reproxalap, an investigational drug candidate for the treatment of dry eye disease. Although no manufacturing or safety issues were discovered with reproxalap, the FDA stated in the letter that the NDA "failed to demonstrate efficacy in adequate and well controlled studies 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. The letter cited concerns with the trial data presented to the NDA that may have influenced the interpretation of the results, which the FDA stated could be due to methodological difficulties, such as a discrepancy in baseline ratings between treatment groups. According to the proposed FDA dry eye disease guidance, efficacy in dry eye disease can be established with two symptom studies and two sign trials before being evaluated for regulatory approval in the United States. Among other clinical trials of reproxalap, Aldeyra previously completed two trials for ocular redness (a dry eye disease sign) in a dry eye chamber, as well as two dry eye disease symptom field (environmental exposure) trials, which were submitted as part of an original NDA in November. In November 2023, the FDA issued a Complete Response Letter to the first NDA, indicating that at least one further symptom study was required. In August 2024, Aldeyra stated that the primary endpoint of the first dry eye chamber clinical study of reproxalap had been met, and the NDA was resubmitted in October 2024. A Type A meeting is expected to take place within the next 30 days to address the Complete Response Letter for the resubmitted NDA and the continuing clinical trials of reproxalap in dry eye condition. Pending positive results from the ongoing clinical trials and discussions with the FDA, we look forward to a potential NDA resubmission mid-year 2025, Reproxalap remains the only late-stage topical ocular therapy suitable for chronic administration to have potentially demonstrated acute reduction in ocular redness, as well as reduction in ocular discomfort, highlighting rapid and broad activity for both the signs and symptoms of dry eye disease. Todd C. Brady Source: Aldeyra Therapeutics Last Modified:

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Aldeyra Therapeutics Responds to the U.S. FDA’s Denial of Reproxalap’s NDA Application for Treating Signs and Symptoms of Dry Eye Disease

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