Bausch + Lomb announced the initiation of the second of two phase 3 studies evaluating the investigational treatment NOV03 (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 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. 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 8 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.