FDA Reviews Aldeyra's Drug for Dry Eye; AbbVie Agreement Expanded

Aldeyra Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for topical ocular reproxalap, an innovative drug candidate intended for the treatment of dry eye disease. The FDA has set a Prescription Drug User Fee Act (PDUFA) date for April 2, 2025. Alongside this announcement, Aldeyra has expanded its exclusive option agreement with AbbVie Inc.

Todd C. Brady, the President and Chief Executive Officer of Aldeyra, conveyed satisfaction with the FDA's decision to review the resubmitted NDA, emphasizing the dedication of both Aldeyra and AbbVie to swiftly introduce a new treatment for dry eye disease to patients and healthcare providers.

On October 31, 2023, Aldeyra and AbbVie entered into an option agreement under which AbbVie holds the right to obtain a co-exclusive license to develop, manufacture, and market reproxalap in the United States. Should AbbVie exercise this option, they would make an upfront cash payment of $100 million to Aldeyra, minus previously paid option fees of $6 million. Further, Aldeyra stands to receive up to $300 million in additional regulatory and commercial milestone payments, including a $100 million milestone payment upon FDA approval of reproxalap for dry eye disease. The commercial arrangement in the U.S. would involve a profit and loss sharing model, with 60% allocated to AbbVie and 40% to Aldeyra.

As part of the expanded agreement, Aldeyra will start pre-commercial activities, with costs split such that AbbVie covers 60% and Aldeyra covers 40% if AbbVie exercises its option. AbbVie has also commenced its own pre-commercial planning activities independently. The option's expiration date has been amended to 10 business days following the FDA's potential approval of reproxalap for dry eye disease.

Reproxalap is an investigational drug developed for the treatment of dry eye disease and allergic conjunctivitis, both significant areas within ophthalmology. As a first-in-class small-molecule modulator of reactive aldehyde species (RASP), reproxalap targets elevated levels in both ocular and systemic inflammatory diseases. Its mechanism of action has shown statistically significant and clinically relevant results in various late-phase clinical trials. Over 2,500 patients have participated in studies of reproxalap, with the most common adverse event being mild and transient irritation at the application site.

Aldeyra Therapeutics is a biotechnology company focused on discovering therapies for immune-mediated and metabolic diseases. Their approach involves modulating protein systems to optimize multiple pathways simultaneously while reducing toxicity. Among Aldeyra’s product candidates are RASP modulators ADX-629, ADX-248, ADX-743, and ADX-631, aimed at treating systemic and retinal immune-mediated and metabolic diseases. The company’s advanced product candidates include reproxalap for dry eye disease and allergic conjunctivitis, and ADX-2191, an innovative formulation of intravitreal methotrexate for retinitis pigmentosa.