Enrollment Completed in Phase 3 Study of Dry Eye Treatment NOV03
January 19, 2021
1 min read
Bausch + Lomb and Novaliq have completed recruitment in a Phase 3 study evaluating NOV03 for the treatment of signs and symptoms of dry eye 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 the results of the phase 2 SEECASE clinical study evaluating NOV03. The therapy met its primary efficacy endpoint of statistically significant improvement in total corneal fluorescein staining compared to the 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 eyes.
“We are committed to addressing unmet patient needs and believe that NOV03, if approved, could be a first-rate treatment option for the millions of patients who suffer from dry eye disease associated with meibomian gland dysfunction. ” Joseph C. Papa, chairman and chief executive officer of Bausch Health, said in the statement.
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 EyeSol technology from Novaliq.