Aldeyra Therapeutics announced that its New Drug Application (NDA) for topical ocular reproxalap, a first-of-its-kind drug candidate for treating dry eye disease symptoms and signs, has been accepted by the U.S. Food and Drug Administration (FDA). The FDA has set November 23, 2023 as the Prescription Drug User Fee Act (PDUFA) date, with no identified potential review issues, and no advisory committee meeting currently scheduled.
“NDA acceptance marks a critical regulatory milestone for Aldeyra as reproxalap continues to advance toward potential regulatory approval for the treatment of dry eye disease,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Based on data from a number of late-stage clinical trials, we believe reproxalap has the potential to address the need for a rapid and durable ophthalmic therapy for the millions of dry eye disease patients who are dissatisfied with currently available therapies.”
The New Drug Application (NDA) for topical ocular reproxalap is supported by the results of five well-controlled clinical trials that have analyzed the efficacy and safety of the drug. These trials cover various aspects of dry eye disease, such as ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis.
The NDA encompasses a wide range of treatment times, from immediate effects to 12 weeks, and includes both crossover and parallel-group clinical trial designs, as well as evaluations in both dry eye chamber challenge and natural environment settings. With over 2,000 patients studied, no significant safety concerns have been reported; the most common adverse event in clinical trials is mild and short-lived irritation at the site of instillation.
Reproxalap, a drug candidate currently under investigation, is a first-of-its-kind small molecule that modulates RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory diseases. The way in which reproxalap works has been shown through statistically significant and clinically significant results in multiple late-phase clinical indications that differ in their physiology.