The FDA has accepted the resubmitted new drug application for reproxalap, an investigational treatment for dry eye disease, and assigned a Prescription Drug User Fee Act date, according to a press release from Aldeyra Therapeutics.
The new PDUFA date has been set for April 2, 2025. As Healio previously reported, the FDA did not approve Aldeyra’s initial submission for reproxalap.
In addition, the company reported the expansion of its exclusive option agreement with AbbVie, which grants AbbVie the option to obtain a co-exclusive license to develop, manufacture and commercialize reproxalap