FDA Rejects Aldeyra's Reproxalap For Dry Eye Disease Again, Citing Efficacy Concerns
Benzinga (Thu, 03-Apr 9:37 AM)
The U.S. Food and Drug Administration (FDA) on Thursday issued a Complete Response Letter for Aldeyra Therapeutics, Inc.’s (NASDAQ:ALDX) resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for dry eye disease.
The FDA stated that the NDA “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of a dry eye” should be conducted.
The letter identified concerns with the trial data submitted to the NDA that may have affected the interpretation of the results.
The FDA stated that these concerns may be related to methodological ...
