The FDA accepted a resubmitted new drug application for reproxalap, a first-in-class investigational topical therapy for dry eye disease, according to a press release from Aldeyra Therapeutics.
The FDA, which did not approve a previous resubmission for reproxalap in April, set a Prescription Drug User Fee Act date of Dec. 16.
Reproxalap is a small-molecule drug that modulates reactive aldehyde species, which are molecules that are elevated in ocular and systemic inflammatory diseases, according to Aldeyra.
The FDA accepted NDAs for reproxalap in February 2023 and October 2024, but both times the