Aldeyra Begins Phase 3 Trial for Reproxalap's Dry Eye Drug Application

Massachusetts-based Aldeyra Therapeutics, a firm at the forefront of developing novel therapies for immune and metabolic disorders, has commenced a Phase 3 clinical trial for its topical ocular solution, 0.25% reproxalap. This investigational RASP modulator is being studied for its efficacy in treating dry eye disease, with the first patient now enrolled in the trial.

The study is a critical step towards the potential resubmission of the New Drug Application (NDA) for reproxalap to the U.S. Food and Drug Administration (FDA). Aldeyra is hopeful that positive outcomes will pave the way for resubmission in late 2024. The company plans to propose a label that highlights both chronic and acute symptom improvements, including a reduction in ocular redness—a novel feature for a chronically administered drug in this domain.

Participants in the trial will initially receive a placebo before being exposed to a controlled dry eye environment. Eligible subjects will then be randomly assigned to receive either the actual drug or the placebo under similar conditions. The trial is designed to enroll approximately 110 individuals to evaluate ocular discomfort as the primary outcome. Prior trials of reproxalap have shown a significant reduction in discomfort compared to the placebo, a finding that Aldeyra will build upon in this Phase 3 study.

To ensure a comprehensive assessment that accounts for disease variability and environmental factors, Aldeyra will conduct the trial in parallel with a traditional six-week field study. The company's financial projections, with $133.0 million in cash and equivalents as of March 2024, indicate that Aldeyra is well-funded to support its operations through the end of 2026 and beyond.

Aldeyra's innovative approach focuses on modulating protein systems to optimize multiple biological pathways simultaneously while reducing toxicity. Their pipeline includes several RASP modulators, such as ADX-629, ADX-246, and ADX-248, aimed at addressing a range of immune and metabolic conditions. Among their advanced candidates, reproxalap is positioned for dry eye disease and allergic conjunctivitis, while ADX-2191 is being developed for retinitis pigmentosa.

Aldeyra's mission is to bring forward transformative treatments that can significantly improve patient outcomes. The ongoing Phase 3 trial is a testament to their commitment to advancing reproxalap as a potential new option for those suffering from dry eye disease.