Bausch Health initiates second phase III study for NOV0 3 treatment for dry eye disease associated with meibomian gland dysfunction.

Bausch Health Companies Inc.,and Bausch + Lomb, its leading global eye health business, announced that the Company has initiated the second of two Phase III studies evaluating the investigational treatment NOV0 3 (perfluorohexyloctane) as a first-in-class investigational drug with a novel mechanism of action to treat the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian gland dysfunction (MGD). Enrollment of the first Phase III study is currently underway and has reached 85% of its enrollment goal. NOV0 3 is an investigational, proprietary, water-free and preservative-free solution, based on patented EyeSol technology from Novaliq GmbH. DED ( dry eye disease) is a chronic and serious disease of the ocular surface. In a Phase II study of 336 patients, NOV0 3 met its primary efficacy endpoint of statistically significant improvement of total corneal fluorescein staining over control at eight weeks. In addition, NOV0 3 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 II study with no notable safety events.