ALDX - FDA Rejects Aldeyra Therapeutics' Dry Eye Disease Candidate Asks For Additional Study | Benzinga
The FDA issued a complete response letter to Aldeyra Therapeutics Inc's (NASDAQ: ALDX) New Drug Application (NDA) of reproxalap, an investigational drug candidate for dry eye disease.
Although no safety or manufacturing issues with reproxalap were identified, the FDA stated in the letter that the NDA did not demonstrate "efficacy 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 ...