Aldeyra Therapeutics announced that the U.S. Food & Drug Administration (FDA) has officially accepted for review the resubmitted new drug application (NDA) for its topical ocular therapy, reproxalap, aimed at treating the signs and symptoms of dry eye disease. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of April 2, 2025.

In parallel with the NDA acceptance, Aldeyra has also expanded its existing exclusive option agreement with AbbVie. The initial agreement between Aldeyra and AbbVie, established on Oct. 31, 2023, provided AbbVie the option to acquire a co-exclusive license to develop, manufacture, and commercialize reproxalap in the U.S. The expansion provides for Aldeyra and AbbVie to initiate pre-commercial activities in preparation for a potential launch, pending FDA approval. 

Reproxalap targets reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory conditions. The drug’s mechanism of action aims to reduce inflammation, thereby alleviating the discomfort associated with dry eye disease, according to Aldeyra.