Aldeyra to Appeal FDA Rejection of Reproxalap for Dry Eye Disease

Aldeyra to Appeal FDA Rejection of Reproxalap for Dry Eye Disease

Aldeyra Therapeutics (NASDAQ:ALDX) said it plans to submit a formal dispute resolution request, or FDRR, to the FDA’s Office of New Drugs seeking review of the agency’s latest complete response letter for reproxalap, its investigational treatment for the signs and symptoms of dry eye disease. The c

Aldeyra Plans to Appeal FDA Rejection of Reproxalap NDA

Key Takeaways Aldeyra plans to formally appeal the FDA's March 2026 Complete Response Letter for reproxalap through a Formal Dispute Resolution Request, with submission and a meeting expected in the fourth quarter of 2026 The company has received 3 complete response letters for the dry eye disease NDA and says it has submitted data from 9 adequate and well-controlled trials Aldeyra Therapeutics announced plans to submit a Formal Dispute Resolu…