Aldeyra Therapeutics is moving forward with plans to resubmit a New Drug Application (NDA) for topical ocular 0.25% reproxalap for the treatment of dry eye disease, following constructive dialogue with the FDA. The decision comes after the company received a Complete Response Letter (CRL) in November 2023, where the FDA cited the need for additional evidence of efficacy in treating ocular symptoms associated with dry eyes.
To address the FDA's concerns, Aldeyra plans to initiate a dry eye chamber clinical study in the first half of 2024. This study is designed to evaluate the primary endpoint of ocular discomfort in approximately 100 patients. The trial will involve administering a vehicle (drug product without the active ingredient) before and during exposure to a dry eye chamber. Qualifying patients will then be randomized to receive either reproxalap or the vehicle before and during a subsequent exposure. The study aims to demonstrate a statistically significant reduction in ocular discomfort in the dry eye chamber following treatment with reproxalap compared to the vehicle.
Resubmission Timeline and FDA Review
Subject to the success of the planned clinical study, Aldeyra anticipates resubmitting the reproxalap NDA for the dry eye disease indication in the second half of 2024. The FDA has indicated a six-month review period from the acceptance date of the resubmitted NDA.
Aldeyra is also planning to conduct another dry eye chamber clinical study to account for disease heterogeneity and potential differences across clinical sites and environments. This comprehensive strategy underscores the company's commitment to addressing the complexities of dry eye disease.
Financial Position and AbbVie Collaboration
As of December 31, 2023, Aldeyra reported cash and cash equivalents of $142.8 million, which the company projects will be sufficient to fund operations beyond 2026, based on current operating plans. This financial stability supports the ongoing development of reproxalap and other pipeline candidates.
Aldeyra has an existing exclusive option agreement with AbbVie, granting AbbVie the option to acquire a co-exclusive license to develop, manufacture, and commercialize reproxalap within the United States, and an exclusive license outside the United States. If AbbVie exercises this option, Aldeyra would receive a non-refundable option fee of $1 million and an upfront payment of $100 million (less option fees). The licensing agreement could also make Aldeyra eligible for up to $300 million in potential regulatory and commercial milestone payments, including $100 million upon FDA approval of reproxalap for dry eye disease. Under the potential agreement, Aldeyra and AbbVie would share profits and losses from commercialization of reproxalap in the United States at a ratio of 60:40. Outside the United States, Aldeyra would be eligible to receive tiered royalties on net sales of reproxalap.
Other Pipeline Programs
In addition to reproxalap, Aldeyra is also developing oral ADX-629, currently in Phase 2 trials for moderate alcoholic hepatitis and Sjögren-Larsson syndrome. Aldeyra's clinical-stage immunology pipeline includes reproxalap and ADX-629, which are in late-stage and mid-stage development, respectively.
Dry eye disease is a potentially debilitating and increasingly pervasive condition that affects millions of patients worldwide. The resubmission of the NDA for reproxalap represents a significant step forward in addressing this unmet medical need.
