Aldeyra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its resubmitted New Drug Application (NDA) for reproxalap, a first-in-class topical treatment for the signs and symptoms of dry eye disease. The FDA has set a target action date of December 16, 2025, under the Prescription Drug User Fee Act (PDUFA).
The NDA resubmission includes results from a single additional clinical trial, conducted per FDA guidance, that successfully met its primary endpoint—demonstrating a significant reduction in ocular discomfort compared to vehicle control.
“Reproxalap continues to show promise as a unique treatment for dry eye disease, particularly in addressing the acute flares that many patients find most troubling,” said Dr. Todd C. Brady, President and CEO of Aldeyra. “We look forward to continued engagement with the FDA throughout the review process.”
If approved, reproxalap would become the first therapy of its kind to demonstrate rapid symptom relief in dry eye disease flare models, positioning it as a potential new option for millions of patients affected by the condition.