FDA Accepts Aldeyra’s NDA for Reproxalap in Dry Eye Disease; Partnership with AbbVie Expands

Aldeyra Therapeutics has announced a major milestone as the FDA formally accepted its resubmitted New Drug Application (NDA) for reproxalap, a topical ocular therapy for the treatment of dry eye disease. Alongside this regulatory progress, Aldeyra has expanded its exclusive option agreement with AbbVie to accelerate pre-commercial activities in anticipation of a potential launch.

FDA NDA Acceptance for Reproxalap

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 2, 2025, for reproxalap. This first-in-class small-molecule therapy addresses reactive aldehyde species (RASP), elevated in both ocular and systemic inflammatory conditions, to reduce inflammation and alleviate symptoms of dry eye disease.

Proven Clinical Efficacy and Safety

       • Patient Data: Reproxalap has been evaluated in over 2,500 patients during multiple late-stage trials.

       • Efficacy: The investigational therapy demonstrated significant clinical efficacy in reducing the signs and symptoms of dry eye disease.

       • Safety: No major safety concerns were reported. The most common side effect was mild, transient eye irritation.

Expanded Partnership with AbbVie

Aldeyra and AbbVie’s exclusive option agreement, initially established on October 31, 2023, has now been expanded. The collaboration highlights both companies’ commitment to accelerating the availability of reproxalap.

Key Terms of the Partnership

1. Pre-Commercial Activities

          • Aldeyra and AbbVie will share pre-commercial costs: 

                      - 60% covered by AbbVie

                      -40% covered by Aldeyra

          • AbbVie has already begun its own pre-commercial planning efforts.

2. 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.

3. 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.

Todd C. Brady, MD, PhD, President and CEO of Aldeyra, expressed optimism about the expanded collaboration:

“Based on the FDA’s acceptance of the NDA resubmission of reproxalap for dry eye disease, we are pleased to announce an expansion of our option agreement with AbbVie. This highlights the commitment of both companies to accelerating the availability of a novel therapy to patients and physicians.”

A Potential Game-Changer in Dry Eye Disease Treatment

Reproxalap’s innovative mechanism of action and strong clinical results position it as a promising new treatment for dry eye disease. With FDA approval pending and a strengthened partnership with AbbVie, Aldeyra is poised to bring this breakthrough therapy to market, addressing a significant unmet need in ocular health.