On March 17, 2026, Aldeyra Therapeutics, Inc. announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for reproxalap, an investigational drug candidate intended for the treatment of dry eye disease. The CRL indicated that there is a lack of substantial evidence from adequate and well-controlled investigations to support the efficacy of reproxalap under the proposed conditions of use. The FDA expressed concerns about the reliability and meaningfulness of the positive findings from the clinical trials conducted, stating that the totality of evidence does not support the effectiveness of the product. No safety or manufacturing concerns were identified during the review process. Aldeyra plans to request a Type A meeting with the FDA to discuss the actions needed for potential approval of the NDA. The company reported that as of December 31, 2025, it had cash, cash equivalents, and marketable securities expected to support operations into 2028. This development raises significant concerns regarding the future of reproxalap and its potential market entry, as the FDA did not recommend conducting additional trials or submitting further confirmatory evidence, which could delay the approval process and impact Aldeyra's financial stability.

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