Patients treated with AR-15512 showed higher rates of at least a 10-mm improvement in unanesthetized Schirmer’s score, a metric of tear production.
Tag Archive for: dry eye disease
Aldeyra Therapeutics is planning to run another trial, in line with the regulator’s requirements, and is expecting top-line data and a New Drug Application resubmission in the first half of 2024.
This follows a late-cycle review meeting in which the regulator flagged “substantive review issues” with the New Drug Application (NDA). The FDA pointed out to Aldeyra that it does not appear to “have data to support the clinical relevance of the ocular signs to support your dry eye indication,” according to the company’s SEC filing.
The regulator’s approval makes Miebo the first DED treatment that directly addresses tear evaporation. The drug is expected to hit U.S. markets in the second half of 2023.
Lexington, Mass.-based Aldeyra Therapeutics reported that the company’s reproxalap hit the mark in the Phase III Tranquility-2 study for dry eye disease. The drug showed statistical superiority for its two primary endpoints.