Aldeyra Therapeutics announced on April 3, 2025, that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the resubmitted New Drug Application (NDA) of reproxalap. This investigational drug is for the treatment of dry eye disease. The FDA stated that the NDA failed to demonstrate efficacy in adequate and well-controlled studies for ocular symptoms.
The FDA's letter requested at least one additional adequate and well-controlled study to show a positive effect on the treatment of ocular symptoms of dry eye. Concerns were identified with the submitted trial data, which the FDA stated may be related to methodological issues, including differences in baseline scores across treatment arms. However, no manufacturing or safety issues with reproxalap were identified in the letter.
Aldeyra plans to hold a Type A meeting with the FDA within approximately 30 days to discuss the CRL and ongoing clinical trials. The company expects to announce top-line results from two additional dry eye disease trials in the second quarter of 2025. Subject to positive results and further discussions with the FDA, Aldeyra intends to resubmit the NDA for a third time by mid-year 2025, with an anticipated six-month review period. As of December 31, 2024, Aldeyra reported $101 million in cash, cash equivalents, and marketable securities.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.