Aldeyra Therapeutics announced NDA acceptance for reproxalap for dry eye, expansion of exclusive option agreement
The dry eye drug has been assigned a PDUFA decision date of April 2, 2025, and the Aldeyra has chosen to expand their exclusive option agreement with AbbVie.
Image credit: AdobeStock/Tunatura
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.
As previously reported by Optometry Times, Aldeyra Therapeutics resubmitted their NDA to the FDA for reproxalap for the signs and symptoms of dry eye in October 2024 following 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.2 The new submission featured a draft label reflecting acute activity in reducing ocular redness in 2 dry eye chamber trials, and the application was padded with additional positive results from a DED symptom trial that were left out of the original submission.3 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
1. 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
2. FDA issues complete response letter to Aldeyra Therapeutics for reproxalap NDA. Optometry Times. November 29, 2023. Accessed November 19, 2024. https://www.optometrytimes.com/view/fda-issues-complete-response-letter-to-aldeyra-therapeutics-for-reproxalap-nda
3. Aldeyra Therapeutics resubmits NDA for reproxalap for DED signs and symptoms treatment. Optometry Times. October 3, 2024. Accessed November 19, 2024. https://www.optometrytimes.com/view/aldeyra-therapeutics-resubmits-nda-for-reproxalap-for-ded-signs-and-symptoms-treatment
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