FDA accepts Aldeyra’s NDA for reproxalap, sets PDUFA date for April 2025
Aldeyra Therapeutics, Inc announced that the U.S. Food and Drug Administration has accepted the resubmitted New Drug Application (NDA) for its investigational drug, topical ocular reproxalap, for the treatment of dry eye disease. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 2, 2025.
Reproxalap, a first-in-class therapy, aims to address the signs and symptoms of dry eye disease. In parallel with the FDA’s acceptance, Aldeyra has expanded its exclusive option agreement with AbbVie Inc.
Under the terms of the agreement, originally signed in October 2023, AbbVie holds an option to co-develop and commercialize reproxalap in the U.S. If the option is exercised, AbbVie would pay Aldeyra $100 million upfront and up to $300 million in milestone payments, including $100 million upon FDA approval. The companies would share U.S. commercialization profits and losses, with 60% allocated to AbbVie and 40% to Aldeyra.
The expanded agreement allows both companies to initiate pre-commercial activities, with costs split similarly. AbbVie’s option now expires 10 business days after potential FDA approval.
Aldeyra CEO Todd C. Brady, MD, PhD, emphasized the partnership’s shared commitment to advancing new treatment options for dry eye disease.
Read the full press release here.
