FDA accepts Aldeyra Therapeutics' potential "first-in-class" dry eye therapy for market application.

Aldeyra Therapeutics (ALDX.US) announced today (November 19) that the U.S. FDA has accepted its resubmitted New Drug Application (NDA) for reproxalap, an innovative ophthalmic drug for the treatment of dry eye disease. The Prescription Drug User Fee Act (PDUFA) date for this application is April 2, 2025. At the same time, Aldeyra also announced an expansion of its exclusive option agreement with AbbVie. Reproxalap is a potential "first-in-class" investigational small molecule reactive aldehyde species inhibitor. Levels of reactive aldehyde species increase in ocular or systemic inflammation, leading to eye inflammation, decreased tear secretion, red eyes, and changes in the lipid composition of tears. Many patients with dry eye disease have high levels of reactive aldehyde species.