According to the company, reproxalap is a small-molecule modulator of reactive aldehyde species that will be used for the treatment of the signs and symptoms of dry eye disease.
Aldeyra Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for topical ocular reproxalap. According to a press release, reproxalap is a “first-in-class, small-molecule modulator of RASP (reactive aldehyde species)” that will be used for the treatment of the signs and symptoms of dry eye disease.
According to the release, the FDA assigned a Prescription Drug User Fee Act (PDUFA) date of November 23, 2023. The FDA noted no potential filing review issues have been identified, and an advisory committee meeting is not currently planned.
Todd C. Brady, MD, PhD, president and CEO of Aldeyra stated in the release the importance of this step in FDA approval.
“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,” said Brady. “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.”
According to the release, the NDA is supported by previously announced safety and efficacy results from 5 clinical trials encompassing data for ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis.
The company noted that the NDA includes activity ranging from within minutes of drug administration to up to 12 weeks of treatment, crossover and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings.