Aldeyra Therapeutics faces significant challenges in approving dry eye drug repproxalap. In October 2023, its stock fell nearly 70% after the release of minutes from a meeting with the FDA that identified material problems with data on the clinical relevance of eye symptoms.[1] The FDA has indicated a possible Complete Response Letter (CRL) before the planned PDUFA date of November 23, 2023.[1] In April 2025, the company received a CRL that cited methodological problems in the previous dry eye study, including differences in baseline values between groups, and required further study of symptoms.[3] In June 2025, Aldeyra resubmitted a New Drug Application (NDA) to the FDA.[3] In its annual SEC 10-K report, it reported a net loss of $33.8 million, down from $55.9 million the previous year.[2] The company focuses on developing therapies for immune-mediated diseases.[3]