The FDA has formally accepted Aldeyra Therapeutics' resubmitted New Drug Application (NDA) for reproxalap, a topical ocular therapy intended for the treatment of dry eye disease. This regulatory advancement is coupled with an expanded exclusive option agreement with AbbVie, aimed at accelerating pre-commercial activities in anticipation of a potential market launch. The Prescription Drug User Fee Act (PDUFA) target action date has been set for April 2, 2025.
Reproxalap: A Novel Approach to Dry Eye Treatment
Reproxalap is a first-in-class small-molecule therapy designed to address reactive aldehyde species (RASP), which are elevated in both ocular and systemic inflammatory conditions. By modulating RASP, reproxalap aims to reduce inflammation and alleviate the symptoms associated with dry eye disease. Clinical data supporting the NDA includes results from multiple late-stage trials involving over 2,500 patients. These trials have demonstrated significant clinical efficacy in reducing the signs and symptoms of dry eye disease, with a favorable safety profile characterized by mild, transient eye irritation as the most commonly reported side effect.
Expanded Partnership with AbbVie
The collaboration between Aldeyra and AbbVie, initially established on October 31, 2023, has been broadened to expedite the availability of reproxalap to patients. Key terms of the partnership include:
- Pre-Commercial Activities: AbbVie will cover 60% of the pre-commercial costs, with Aldeyra covering the remaining 40%. AbbVie has already commenced its pre-commercial planning efforts.
- Option Terms and Payments: If AbbVie exercises its option, it will make a $100 million upfront payment to Aldeyra, reduced by $6 million in prior option fees. The option expiration has been extended to 10 business days after potential FDA approval.
- Regulatory and Commercial Milestones: Aldeyra is eligible for up to $300 million in milestone payments, including a $100 million milestone upon FDA approval. A profit-sharing model will split U.S. commercialization profits, with 60% for AbbVie and 40% for Aldeyra.
Addressing an Unmet Need
Dry eye disease is a common inflammatory condition affecting millions of adults in the United States. Existing therapies often require weeks or months to demonstrate activity, leaving a significant portion of patients dissatisfied. Reproxalap's innovative mechanism of action and robust clinical results position it as a promising new treatment option, potentially offering rapid and durable relief for those suffering from dry eye disease. According to Aldeyra's CEO, Todd C. Brady, MD, PhD, the expanded collaboration with AbbVie underscores the commitment of both companies to accelerating the availability of this novel therapy to patients and physicians.
