Aldeyra Therapeutics’ Reproxalap NDA Accepted for Review by US FDA for Dry Eye Disease
Friday, July 18, 2025
Aldeyra Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for reproxalap, a topical ocular treatment developed for dry eye disease.
Dry eye disease is a common condition that occurs when the eyes do not produce enough tears or when the tears evaporate too quickly. This leads to inflammation and damage to the surface of the eye. People with dry eye disease often experience symptoms such as stinging, burning, redness, blurred vision, and a gritty sensation in the eyes.
Reproxalap is a first-in-class investigational small molecule designed to modulate reactive aldehyde species (RASP), which are linked to ocular and systemic inflammation. It is being developed for both dry eye disease and allergic conjunctivitis—two of the most common conditions in ophthalmology.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 16 December 2025.
The NDA resubmission follows the FDA’s previous request for an additional clinical trial demonstrating reproxalap’s effectiveness in reducing symptoms of dry eye disease. The revised application includes data from a single trial that successfully met its primary endpoint, showing a reduction in ocular discomfort when compared to a vehicle control.
The investigational therapy has been tested in more than 2,900 individuals across multiple late-stage clinical studies. The results have shown statistically significant and clinically meaningful effects without major safety concerns.
The most frequently reported side effect was mild and temporary irritation at the site of application.
Source: aldeyra.com
