FDA Accepts Aldeyra's NDA for Reproxalap in Dry Eye Disease; Expands Partnership with AbbVie
Aldeyra Therapeutics announced that the 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 October 31, 2023, provided AbbVie the option to acquire a co-exclusive license to develop, manufacture, and commercialize reproxalap in the US. Under the terms of the agreement, should AbbVie exercise its option, it would make a $100 million upfront payment to Aldeyra, reduced by $6 million in previously paid option fees.
The expansion provides for Aldeyra and AbbVie to initiate pre-commercial activities in preparation for a potential launch, pending FDA approval.
“Based on the FDA’s acceptance of the NDA resubmission of reproxalap for dry eye disease, we are pleased to announce an expansion of our option agreement with AbbVie. This highlights the commitment of both companies to accelerating the availability of a novel therapy to patients and physicians," Todd C. Brady, MD, PhD, President and CEO of Aldeyra, said in a company news release.
Under the revised terms, Aldeyra and AbbVie will share pre-commercial costs, with AbbVie covering 60% and Aldeyra the remaining 40%. Additionally, AbbVie has initiated its own pre-commercial planning activities. The expiration of AbbVie’s option has also been extended to 10 business days following FDA approval, should it occur. If AbbVie exercises its option and FDA approval for reproxalap is granted, Aldeyra will be eligible to receive up to $300 million in regulatory and commercial milestone payments. This figure includes a $100 million milestone payment contingent upon the FDA’s approval of the drug. The profit-sharing agreement for commercialization in the United States will be split 60% to AbbVie and 40% to Aldeyra.
As a first-in-class small-molecule therapy, 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. The investigational therapy has demonstrated significant clinical efficacy across multiple late-stage trials and has been evaluated in over 2,500 patients. Clinical studies revealed no significant safety concerns, with mild, transient eye irritation being the most commonly reported side effect.