The FDA has accepted for review Aldeyra Therapeutics' resubmitted New Drug Application (NDA) for reproxalap, a topical ocular therapy aimed at treating the signs and symptoms of dry eye disease (DED). The agency has set a Prescription Drug User Fee Act (PDUFA) target date of April 2, 2025, for its decision. This announcement coincides with an expansion of Aldeyra's existing exclusive option agreement with AbbVie, signaling a strengthened commitment to bringing this novel therapy to market.
Financial Implications of the AbbVie Agreement
Under the terms of the expanded agreement, AbbVie has the option to obtain a co-exclusive license to develop, manufacture, and commercialize reproxalap in the United States. If AbbVie exercises this option, Aldeyra would receive a $100 million upfront cash payment (less previously paid option fees). Furthermore, Aldeyra is eligible for up to $300 million in regulatory and commercial milestone payments, including $100 million upon FDA approval of reproxalap for DED. In the U.S., profits and losses from commercialization would be shared, with AbbVie holding a 60% stake and Aldeyra 40%.
Collaborative Pre-Commercial Activities
The expanded option agreement also outlines that Aldeyra will initiate certain pre-commercial activities, with AbbVie covering 60% of the associated costs if the option is exercised. AbbVie has also independently begun its own pre-commercial planning. The expiration of AbbVie’s option has been extended to 10 business days following potential FDA approval of reproxalap for DED.
Reproxalap: A Novel Approach to Dry Eye Disease
Reproxalap is a first-in-class, small-molecule modulator of reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory conditions. The drug's mechanism of action focuses on reducing inflammation to alleviate the symptoms of dry eye disease. It has demonstrated statistically significant and clinically relevant activity in multiple late-phase clinical trials. In these trials, involving over 2,500 patients, the most commonly reported adverse event was mild and transient instillation site irritation, with no significant safety concerns observed.
Addressing Unmet Needs in Dry Eye Treatment
Dry eye disease is a prevalent condition affecting millions worldwide, characterized by insufficient lubrication of the eye surface, leading to discomfort and visual disturbances. Current treatments often provide only symptomatic relief, highlighting the need for therapies that target the underlying inflammatory processes. The potential approval of reproxalap could represent a significant advancement in the treatment landscape for dry eye disease.
