FDA Accepts Aldeyra's Reproxalap NDA for Dry Eye, AbbVie Expands Option Agreement
Key Insights
The FDA has accepted Aldeyra Therapeutics' resubmitted NDA for reproxalap to treat the signs and symptoms of dry eye disease (search).
AbbVie (search) has expanded its option agreement with Aldeyra, providing $100 million upfront and up to $300 million in milestone payments.
The NDA includes positive results from a Phase 3 trial demonstrating reproxalap's superiority over vehicle for ocular discomfort (P=0.004).
The FDA has accepted Aldeyra Therapeutics' resubmitted New Drug Application (NDA) for reproxalap, a topical ocular solution being investigated for the treatment of signs and symptoms of dry eye disease (search). This acceptance coincides with an expansion of Aldeyra's option agreement with AbbVie (search), providing Aldeyra with additional funding to support the potential commercialization of the drug.
Financial Implications of AbbVie Agreement
Under the expanded agreement, AbbVie (search) will pay Aldeyra $100 million upfront. Aldeyra is also eligible to receive up to $300 million in regulatory and commercial milestone payments if reproxalap receives FDA approval for treating the signs and symptoms of dry eye disease (search). If the drug is commercialized, profits and losses will be shared, with AbbVie taking a 60% stake and Aldeyra 40%.
Background on Reproxalap NDA
The resubmission of the NDA in October 2024 follows a Complete Response Letter issued by the FDA in November 2023, which cited a lack of efficacy as a barrier to approval. The updated NDA includes positive data from a recently completed dry eye disease (search) symptom trial requested by the FDA. The application also features a draft label that reflects acute activity in reducing dry eye symptoms in a dry eye chamber trial, chronic activity in reducing dry eye symptoms in a field trial, and acute activity in reducing ocular redness in two dry eye chamber trials.
Clinical Trial Data
The data supporting the NDA includes results from a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial. The trial demonstrated that reproxalap was statistically superior to the vehicle for the primary endpoint of ocular discomfort (P=0.004).
PDUFA Date and Commercialization Plans
Following the NDA acceptance, the FDA assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025. Aldeyra and AbbVie (search) will both begin pre-commercial activities for reproxalap. The companies have agreed to extend the option agreement's expiration date to 10 business days following potential FDA approval of reproxalap for dry eye disease (search).
Todd C. Brady, MD, PhD, President and CEO of Aldeyra, stated, "Based on the FDA’s acceptance of the NDA resubmission of reproxalap for dry eye disease (search) for review, we are pleased to announce an expansion of our option agreement with AbbVie (search), highlighting the commitment of both companies to accelerating the potential availability of a novel dry eye disease therapy to patients and physicians."