The FDA issued a complete response letter regarding the new drug application for reproxalap for the treatment of dry eye disease, according to a press release from Aldeyra Therapeutics.
The letter did not note any issues with safety or manufacturing but stated that the NDA did not demonstrate efficacy for the treatment of ocular symptoms associated with dry eye, according to the release.
The letter said that “‘at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye’ should (Read more...)