FDA does not approve resubmitted new drug application for reproxalap

Key takeaways:

• According to the FDA, reproxalap did not demonstrate efficacy in treating ocular symptoms of dry eye disease.
• Aldeyra plans to resubmit the new drug application with new trial data later this year.

Editor’s note: This is a developing news story. Please check back soon for updates.

The FDA issued a complete response letter for the resubmission of the reproxalap new drug application for the treatment of signs and symptoms of dry eye disease, according to a press release from Aldeyra Therapeutics.

The FDA cited a lack of efficacy in “adequate and well-controlled studies in treating ocular symptoms associated with dry eyes” as the reason for its decision; no manufacturing or safety issues were reported. The FDA also said methodological issues with trial data may have affected interpretation of the results, including a difference in baseline scores in the treatment arms.

For a dry eye treatment to be considered for regulatory approval, efficacy may be shown in two symptom trials and two sign trials. Aldeyra aims to announce topline data from an ongoing dry eye disease field trial and an ongoing chamber clinical trial in the second quarter.

The FDA did not approve the initial new drug application for reproxalap in November 2023, as Healio previously reported.

“Pending positive results from the ongoing clinical trials and discussions with the FDA, we look forward to a potential NDA resubmission mid-year 2025,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release. “Reproxalap remains the only late-stage topical ocular therapy suitable for chronic administration to have potentially demonstrated acute reduction in ocular redness, as well as reduction in ocular discomfort, highlighting rapid and broad activity for both the signs and symptoms of dry eye disease.”

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