Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap NDA for Dry Eye Disease

Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) recently disclosed in an 8-K SEC filing that the U.S. Food and Drug Administration (FDA) has agreed to review the resubmitted New Drug Application (NDA) for topical ocular reproxalap. This investigational new drug candidate targets the signs and symptoms of dry eye disease. The PDUFA (Prescription Drug User Fee Act) date set for the review is April 2, 2025.

As part of this development, Aldeyra has extended its exclusive option agreement with AbbVie Inc., a significant move indicating both companies’ dedication to advancing a potential therapy for dry eye disease patients. Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, emphasized the expansion of the collaboration with AbbVie in light of the FDA’s acceptance of the NDA resubmission for reproxalap.

Under the terms of the option agreement reached on October 31, 2023, AbbVie holds the right to acquire a co-exclusive license for the development, manufacturing, and commercialization of reproxalap in the U.S. Upon exercising this option, AbbVie would make an upfront cash payment of $100 million to Aldeyra, with further potential milestone and regulatory payments of up to $300 million. Aldeyra would also share profits and losses with AbbVie at a split of 40% to 60% respectively.

With the current agreement expansion, Aldeyra will initiate pre-commercial activities with AbbVie. AbbVie will cover 60% of the costs, considering Aldeyra’s share at 40% if the option is exercised. Furthermore, adjustments have been made to the expiration of the option, which now stands at 10 business days post-FDA approval, if granted, for reproxalap in treating dry eye disease.

Reproxalap, a RASP (reactive aldehyde species) modulator, demonstrates potential for addressing dry eye disease and allergic conjunctivitis, representing significant markets in ophthalmology. With a promising safety profile and positive results in clinical trials, reproxalap’s mechanism of action has shown beneficial effects in various late-phase clinical indications.

Aldeyra Therapeutics is deeply engaged in developing innovative therapies aimed at managing immune-mediated and metabolic conditions. By modulating protein systems to optimize multiple pathways while minimizing side effects, Aldeyra aims to deliver effective pharmaceuticals. In addition to reproxalap, Aldeyra’s product pipeline includes a range of RASP modulators tailored for potential treatments across immune-mediated and metabolic diseases.

This press release highlights the positive strides taken by Aldeyra Therapeutics in collaboration with AbbVie and the FDA’s acceptance of the NDA for reproxalap, marking a significant step forward in potentially addressing the unmet needs of patients suffering from dry eye disease.

For more information, please refer to the complete 8-K SEC filing on Aldeyra Therapeutics’ official website.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Aldeyra Therapeutics’s 8K filing here.

Aldeyra Therapeutics Company Profile

Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company’s lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease, leading to elevated levels of cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A.