FDA CRL - Aldeyra Therapeutics, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Aldeyra Therapeutics, Inc. regarding its New Drug Application (NDA 216442) for Reproxalap Ophthalmic Solution. The FDA determined that the application cannot be approved in its current form due to a lack of substantial evidence that the drug is effective for its intended use. This decision is based on regulatory standards for adequate and well-controlled investigations defined in 21 CFR 314.126. The agency noted that several clinical trials failed to demonstrate efficacy, and the inconsistency of results across the clinical program raises serious concerns regarding the reliability of the positive findings. While the document does not list specific facility inspection dates, the primary issues are clinical rather than manufacturing-based. To address these deficiencies, the FDA recommends that Aldeyra identify the causes for treatment failure and determine if specific patient populations might benefit from the drug. Required actions for the company include submitting a formal resubmission within one year that fully addresses the efficacy concerns and provides an updated safety report according to 21 CFR 314.50. Aldeyra must also resubmit its proposed proprietary name for review and is encouraged to request a meeting with the FDA to discuss the necessary steps for potential approval.