Aldeyra Therapeutics’ Reproxalap NDA for Dry Eye Disease Accepted by FDA
Friday, July 18, 2025
Aldeyra Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for reproxalap, a first-in-class investigational eye drop, for the treatment of dry eye disease. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 16 December 2025.
The resubmission follows a request from the FDA for an additional clinical trial. The new study included in the application met its primary goal by showing a reduction in eye discomfort when compared to a placebo control.
Reproxalap is being developed to treat dry eye disease and allergic conjunctivitis. It works by targeting reactive aldehyde species (RASP), which are elevated in inflammatory eye and systemic conditions. The drug has shown statistically and clinically meaningful results in various late-stage trials.
More than 2,900 patients have taken part in studies of reproxalap. No major safety issues have been observed. The most commonly reported side effect has been mild, short-term irritation where the drops are applied.
The drug is designed to address symptoms such as redness and discomfort, especially during flare-ups, which are considered some of the most troublesome aspects of dry eye disease.
Source: businesswire.com
