The FDA has accepted for review Aldeyra Therapeutics' New Drug Application (NDA) for reproxalap, a first-in-class investigational drug for the treatment of dry eye disease. The Prescription Drug User Fee Act (PDUFA) date is set for April 2, 2025. This announcement coincides with an expansion of Aldeyra's option agreement with AbbVie.
Expansion of AbbVie Option Agreement
Under the expanded agreement, AbbVie has the option to acquire a co-exclusive license to develop, manufacture, and commercialize reproxalap in the United States. Upon exercising this option, AbbVie would pay Aldeyra a $100 million upfront cash payment (less the $6 million in previously paid option fees). Aldeyra is also eligible to receive up to $300 million in regulatory and commercial milestone payments, including $100 million upon FDA approval of reproxalap for dry eye disease. In the U.S., profits and losses from reproxalap commercialization would be split 60% for AbbVie and 40% for Aldeyra.
As part of the expanded agreement, Aldeyra will initiate certain pre-commercial activities, with AbbVie funding 60% of these costs if the option is exercised. The expiration of the option has been amended to 10 business days from the date of potential FDA approval of reproxalap for dry eye disease.
About Reproxalap
Reproxalap is a first-in-class, small-molecule modulator of reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory diseases. It is under development for both dry eye disease and allergic conjunctivitis. Clinical trials involving over 2,500 patients have shown statistically significant and clinically relevant activity, with mild and transient instillation site irritation being the most commonly reported adverse event.
Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, stated, "Based on the FDA’s acceptance of the NDA resubmission of reproxalap for dry eye disease for review, we are pleased to announce an expansion of our option agreement with AbbVie, highlighting the commitment of both companies to accelerating the potential availability of a novel dry eye disease therapy to patients and physicians."
