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FDA accepts NDA from Aldeyra Therapeutics for reproxalap for dry eye
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Key Takeaways
- Aldeyra's NDA for reproxalap, addressing dry eye disease, was accepted by the FDA after previous efficacy concerns were resolved with positive Phase 3 trial results.
- Aldeyra expanded its agreement with AbbVie, securing $100 million upfront and potential $300 million in milestone payments, sharing profits 60%/40% with AbbVie.
A PDUFA decision date of April 2, 2025 has been assigned
(Image Credit: AdobeStock/killykoon)
The FDA has accepted the resubmitted new drug application (NDA) from Aldeyra Therapeutics for its first-in-class investigational candidate, topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease. At the same time, Aldeyra is choosing to expand their option agreement with AbbVie, granting the manufacturer more cash to bring the drug to market.1
“Based on the FDA’s acceptance of the NDA resubmission of reproxalap for dry eye disease for review, we are pleased to announce an expansion of our option agreement with AbbVie, highlighting the commitment of both companies to accelerating the potential availability of a novel dry eye disease therapy to patients and physicians,” Todd C. Brady, MD, PhD, President and CEO of Aldeyra, said in a press release.
With the expansion of their agreement, AbbVie has agreed to pay Aldeyra $100 million upfront; Aldeyra is also eligible to receive up to $300 million in regulatory and commercial milestone payments upon approval by the FDA for reproxalap for the signs and symptoms of dry eye disease. Aldeyra would share a 60%/40% split of profits and losses with AbbVie taking the larger stake if reproxalap is brought to market.
In October 2024, Aldeyra Therapeutics re-submitted their NDA to the FDA for reproxalap for the signs and symptoms of dry eye. This followed a complete response letter issued in November 2023, which cited a lack of efficacy of reproxalap in dry eye disease as a barrier to approval.
The new NDA submission features previously disclosed positive results from a recently completed dry eye disease symptom trial that was requested by the FDA following a review of the previous NDA. The application also includes a draft label reflecting 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.
The data mentioned is from the Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of reproxalap in patients with dry eye disease. Results showed that reproxalap was statistically superior to vehicle for the primary endpoint of ocular discomfort (P=0.004).
Upon acceptance of the NDA, the FDA assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025.1
Aldeyra and AbbVie will both initiate pre-commercial activities for reproxalap, and both companies have agreed to extend the expiration date of the option to 10 business days following FDA approval, if granted, of reproxalap for dry eye disease.
References:
Aldeyra Therapeutics announces FDA acceptance for review of reproxalap new drug application for the treatment of dry eye disease, expands AbbVie option agreement. Aldeyra Therapeutics. Press release. November 18, 2024. Accessed November 19, 2024. https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-fda-acceptance-review-reproxalap
