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