Aldeyra Therapeutics, Inc. is moving forward with plans to resubmit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for reproxalap, a topical ocular 0.25% reactive aldehyde species (RASP) modulator, as a treatment for dry eye disease. The decision follows discussions with the FDA and is contingent upon the success of a planned dry eye chamber clinical trial slated to begin in the first half of 2024. If the trial yields positive results, Aldeyra anticipates resubmitting the NDA in the second half of 2024, with a potential six-month review period by the FDA.
Planned Clinical Trial Details
The proposed dry eye chamber trial will involve approximately 100 patients who will initially receive a vehicle (placebo) before and during exposure to a controlled dry eye environment. Qualifying patients will then be randomized to receive either reproxalap or the vehicle before and during a subsequent exposure. The primary endpoint of the trial is the assessment of ocular discomfort. The trial design and statistical powering are based on data from four previously completed dry eye chamber clinical trials involving reproxalap. According to Aldeyra, prior data, when analyzed with the planned trial design, demonstrated statistically significant lower ocular discomfort with reproxalap compared to the vehicle (p=0.0003). The company expects the planned trial to have over 90% power to detect a difference between the treatment groups.
Addressing Dry Eye Disease
Dry eye disease affects hundreds of millions of people worldwide and is characterized as a multifactorial, progressive condition that significantly impacts quality of life. Sumit Garg, M.D., Professor of Ophthalmology at the University of California Irvine, noted the potential of RASP modulation to provide rapid relief from the signs and symptoms of dry eye.
Comprehensive Development Strategy
In addition to the planned dry eye chamber trial, Aldeyra intends to conduct a separate clinical trial at a different dry eye chamber, along with a traditional six-week field clinical trial. This parallel approach is designed to account for the heterogeneity of the disease and potential variations across clinical sites and environments. Aldeyra's current operating plan projects that its cash and cash equivalents of $142.8 million as of December 31, 2023, will be sufficient to fund operations beyond 2026.
About Reproxalap
Reproxalap is a first-in-class, small-molecule modulator of RASP, which are elevated in ocular and systemic inflammatory diseases. It is under development for the treatment of dry eye disease and allergic conjunctivitis. Clinical trials involving over 2,400 patients have shown statistically significant and clinically relevant activity, with mild and transient instillation site irritation being the most commonly reported adverse event.
