FDA Accepts Aldeyra's Reproxalap NDA for Dry Eye Disease Treatment
Key Insights
The FDA has accepted Aldeyra Therapeutics' resubmitted NDA for reproxalap, a potential first-in-class treatment for dry eye disease (search), with a PDUFA date of April 2, 2025.
Aldeyra has expanded its option agreement with AbbVie (search), highlighting both companies' commitment to advancing a novel therapy for dry eye disease (search).
Reproxalap, a RASP modulator, has demonstrated statistically significant activity in clinical trials with over 2,500 patients, showing a favorable safety profile.
Aldeyra Therapeutics announced that the FDA has accepted for review the resubmitted New Drug Application (NDA) for reproxalap, a topical ocular solution being investigated for the treatment of dry eye disease (search). The FDA has set a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025, for its decision. This acceptance triggers an expansion of Aldeyra's option agreement with AbbVie (search), signaling a strengthened commitment to bringing a novel dry eye therapy to market.
Reproxalap: A Novel Approach to Dry Eye Disease
Reproxalap is a first-in-class, small-molecule modulator of reactive aldehyde species (search) (RASP), which are elevated in ocular and systemic inflammatory diseases. The drug's mechanism of action has demonstrated statistically significant and clinically relevant activity across 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.
Commercialization Agreement with AbbVie
Under the expanded option agreement with AbbVie (search), Aldeyra will initiate certain pre-commercial activities, with AbbVie covering 60% of the costs if the option is exercised. AbbVie has also independently started its pre-commercial planning. The expiration of AbbVie's option has been amended to 10 business days from the date of potential FDA approval of reproxalap for dry eye disease (search).
Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer 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."
Financial Implications of the Agreement
If AbbVie (search) exercises its option, Aldeyra would receive a $100 million upfront cash payment (less $6 million in prior 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 dry eye disease (search). In the United States, profits and losses from reproxalap commercialization would be shared, with AbbVie receiving 60% and Aldeyra 40%.
About Aldeyra Therapeutics
Aldeyra Therapeutics is focused on discovering innovative therapies for immune-mediated and metabolic diseases. Their approach involves modulating protein systems to optimize multiple pathways while minimizing toxicity. Aldeyra's pipeline includes RASP modulators like ADX-629, ADX-248, ADX-743, and ADX-631, targeting systemic and retinal diseases. In addition to reproxalap, Aldeyra's late-stage product candidates include ADX-2191, a novel formulation of intravitreal methotrexate for retinitis pigmentosa (search).