Aldeyra Begins Phase 3 Trial for Reproxalap in Dry Eye Disease

Aldeyra Therapeutics, a biotechnology company focused on developing treatments for immune-mediated and metabolic diseases, has announced the enrollment of the first patient in a Phase 3 trial for a potential dry eye disease treatment. The clinical trial will evaluate the efficacy of topical ocular 0.25% reproxalap, a RASP modulator, in treating dry eye disease. If successful, the results could lead to the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the latter half of 2024.

Aldeyra is hopeful that the positive clinical outcomes will enable them to submit the NDA for reproxalap, which could potentially be the first treatment to feature a label that includes both chronic and acute symptom improvement as well as a reduction in ocular redness for a chronically administered drug. According to FDA guidelines, the review duration for this resubmission is estimated to be around six months.

The clinical trial involves administering a vehicle (the drug without the active ingredient) to patients during their exposure to a dry eye chamber. Qualified patients are then randomly assigned to receive either reproxalap or the vehicle during another exposure to a dry eye chamber. The primary endpoint of this study is ocular discomfort, and around 110 patients are expected to participate. In previous trials, reproxalap demonstrated statistically significant reductions in ocular discomfort compared to the vehicle.

A concurrent clinical trial at a different dry eye chamber, along with a traditional six-week field clinical trial, is also planned. This comprehensive strategy aims to account for disease variability and potential differences in clinical sites and environmental conditions. Based on current financial plans and resources, Aldeyra projects that the company's cash, cash equivalents, and marketable securities, which totaled $133.0 million as of March 31, 2024, will be adequate to support operations beyond the end of 2026.

Aldeyra’s approach focuses on modulating protein systems to treat diseases rather than targeting single protein pathways. Their product pipeline includes RASP modulators like ADX-629, ADX-246, and ADX-248 for treating immune and metabolic diseases. Reproxalap is in the late stages of development for treating dry eye disease and allergic conjunctivitis, while ADX-2191, a novel formulation of intravitreal methotrexate, is being developed for retinitis pigmentosa.

Aldeyra Therapeutics is committed to discovering innovative therapies for immune-mediated and metabolic diseases, leveraging their unique approach to pharmaceutical development. By modulating protein systems, they aim to optimize multiple pathways at once, reducing toxicity and improving efficacy. Their ongoing clinical trials and financial stability position them well for future developments and potential market approvals.