Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA has, for a third time, declined to approve reproxalap for the treatment of dry eye disease, according to a press release from Aldeyra Therapeutics.
According to Aldeyra, a complete response letter from the FDA said there was “a lack of substantial evidence” for reproxalap’s efficacy and that the “inconsistency of study results raises serious concerns about the reliability and meaningfulness of the positive findings.”
The FDA found no safety or manufacturing concerns,