Aldeyra Therapeutics announced on November 18, 2024, that the U.S. Food and Drug Administration (FDA) accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap. This investigational drug is being developed for the treatment of dry eye disease. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 2, 2025, indicating a clear timeline for a regulatory decision.
In conjunction with the FDA's acceptance, Aldeyra also expanded its exclusive option agreement with AbbVie Inc. Under the terms of this expanded agreement, AbbVie retains the option to obtain a co-exclusive license to develop, manufacture, and commercialize reproxalap in the United States. If AbbVie exercises this option, Aldeyra is set to receive a $100 million upfront cash payment, less $6 million in previously paid option fees.
Furthermore, Aldeyra would be eligible for up to $300 million in additional regulatory and commercial milestone payments, including a $100 million milestone upon FDA approval of reproxalap. The companies have also agreed to share U.S. profits and losses from commercialization, with AbbVie receiving 60% and Aldeyra 40%. The option exercise period was amended to expire ten business days following FDA approval, and Aldeyra will initiate certain pre-commercial activities, with 60% of costs reimbursed by AbbVie if the option is exercised.
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