Bausch Health Companies Inc. and Bausch + Lomb has announced the initiation of the second of two Phase 3 studies evaluating the investigational treatment NOV03 (perfluorohexyloctane) for Dry Eye Disease (DED). Enrollment of the first Phase 3 study is currently underway and has reached 85% of its enrollment goal.
NOV03 is an investigational, proprietary, water-free and preservative-free solution, based on patented EyeSol® technology from Novaliq GmbH. It is described as a first-in-class investigational drug with a novel mechanism of action to treat the signs and symptoms of DED associated with Meibomian gland dysfunction (MGD). DED is a chronic and serious disease of the ocular surface.
In a Phase 2 study of 336 patients, NOV03 met its primary efficacy endpoint of statistically significant improvement of total corneal fluorescein staining over control at eight weeks. In addition, NOV03 showed statistically significant improvement of certain symptoms, such as severity and frequency of dryness and burning/stinging of the eyes, over the entire duration of the Phase 2 study with no notable safety events.
"Bausch + Lomb, our global eye health business, is focused on researching and bringing forward new options for unmet medical needs, including Dry Eye Disease associated with MGD. It's estimated that more than 16 million Americans suffer from Dry Eye Disease3, and if approved, NOV03 may be the first pharmaceutical therapy available for U.S. patients who have Dry Eye Disease associated with MGD," said Joseph C. Papa, chairman and CEO of Bausch Health.
Full news release: https://ir.bauschhealth.com/news-releases/2020/11-24-2020-120146568