Bausch launches second phase 3 study of NOV03 for dry eye disease
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The second of two phase 3 studies evaluating NOV03 as a first-in-class investigational drug for treatment of signs and symptoms of dry eye disease associated with meibomian gland dysfunction has been initiated.
The first phase 3 study is at 85% enrollment, according to a press release from Bausch Health.
In a phase 2 study, the proprietary NOV03 (perfluorohexyloctane) solution met its primary efficacy endpoint, a statistically significant improvement in total corneal fluorescein staining compared with controls at 8 weeks.
NOV03, which includes no water or preservatives, also improved the severity and frequency of dryness, burning and stinging, and there were no notable safety events, the release said.
“[I]f approved, NOV03 may be the first pharmaceutical therapy available for U.S. patients who have dry eye disease associated with MGD,” Joseph C. Papa, chairman and CEO of Bausch Health, said in the release.
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