Aldeyra Therapeutics Receives CRL From FDA For NDA Of Reproxalap, Investigational Drug Candidate, For Treatment Of Dry Eye Disease

Aldeyra Therapeutics (NASDAQ: ALDX) received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for reproxalap, an investigational drug for dry eye disease. The FDA indicated that the application lacked substantial evidence of efficacy from adequate and well-controlled studies, although no safety or manufacturing concerns were raised. Aldeyra plans to request a Type A meeting with the FDA to discuss the next steps for NDA approval, with the target meeting date expected within 30 days of the request.