FDA accepts NDA for Aldeyra dry eye disease treatment
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The FDA has accepted a new drug application for reproxalap, an investigational new drug candidate for signs and symptoms of dry eye disease, manufacturer Aldeyra Therapeutics announced in a press release.
Reproxalap is a small-molecule modulator of reactive aldehyde species, which are elevated in ocular inflammatory disease, and has been studied in more than 2,000 patients with no clinically significant safety concerns, the company stated.
The NDA is supported by previously announced safety and efficacy results from five clinical trials with data for ocular dryness symptom score, ocular redness and Schirmer test for up to 12 weeks of treatment.
“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,” Todd C. Brady, MD, PhD, Aldeyra president and CEO, said in the release. “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 FDA has assigned a Prescription Drug User Fee Act date of Nov. 23, 2023, for reproxalap. No potential filing review issues have been identified.
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