Enrollment complete in phase 3 study of NOV03 dry eye treatment
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Bausch + Lomb and Novaliq have completed enrollment in a phase 3 study evaluating NOV03 for the treatment of signs and symptoms of dry eye disease associated with meibomian gland dysfunction, according to a press release.
The study is the first of two phase 3 studies evaluating NOV03 (perfluorohexyloctane) and enrolled 599 participants.
In addition, the companies announced the publication of results from the phase 2 SEECASE clinical study evaluating NOV03. The therapy reached its primary efficacy endpoint of statistically significant improvement of total corneal fluorescein staining over control at 8 weeks, the release said. It also showed statistically significant improvement in some symptoms, including the severity and frequency of dryness, burning and stinging of the eyes.
“We are committed to addressing the unmet needs of patients and believe NOV03, if approved, may be a first-in-class treatment option for the millions of patients who suffer from dry eye disease associated with meibomian gland dysfunction,” Joseph C. Papa, chairman and CEO of Bausch Health, said in the release.
Bausch Health and Bausch + Lomb have an exclusive license in the United States and Canada for the commercialization and development of NOV03, which is based on Novaliq’s EyeSol technology.
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