FDA Accepts Aldeyra's Reproxalap NDA for Dry Eye Disease, AbbVie Option Expanded
Key Insights
The FDA has accepted Aldeyra Therapeutics' resubmitted NDA for reproxalap, a novel topical ocular drug, for treating dry eye disease (search), setting a PDUFA date of April 2, 2025.
Aldeyra has expanded its option agreement with AbbVie (search), granting AbbVie the potential to co-exclusively develop and commercialize reproxalap in the U.S.
Upon exercising the option, AbbVie (search) would pay Aldeyra $100 million upfront (less previous fees) and up to $300 million in regulatory and commercial milestones.
The U.S. Food and Drug Administration (FDA) has accepted for review Aldeyra Therapeutics' New Drug Application (NDA) for reproxalap, a first-in-class investigational topical ocular drug aimed at treating the signs and symptoms of dry eye disease (search). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025.
Commercialization Agreement with AbbVie
In conjunction with the NDA acceptance, Aldeyra announced an expansion of its exclusive option agreement with AbbVie (search). Originally established on October 31, 2023, the agreement grants AbbVie the option to obtain a co-exclusive license for the development, manufacturing, and commercialization of reproxalap within the United States.
Should AbbVie (search) exercise this option, Aldeyra would receive an upfront cash payment of $100 million (less the $6 million in previously paid option fees). Furthermore, Aldeyra is eligible for up to $300 million in regulatory and commercial milestone payments, including a $100 million milestone payment upon FDA approval of reproxalap for dry eye disease (search).
Profit Sharing and Pre-Commercial Activities
Under the terms of the agreement, Aldeyra would share profits and losses with AbbVie (search) from the commercialization of reproxalap in the U.S., with a split of 60% for AbbVie and 40% for Aldeyra.
The expanded agreement stipulates that Aldeyra will initiate certain pre-commercial activities, with AbbVie (search) covering 60% of these costs if the option is exercised. AbbVie has also independently begun pre-commercial planning activities. The expiration date of the option has been amended to 10 business days following potential FDA approval of reproxalap for dry eye disease (search).