Enrollment complete in second phase 3 study of NOV03 for dry eye
Click Here to Manage Email Alerts
Bausch + Lomb and Novaliq have completed enrollment in a second phase 3 study investigating NOV03 for the treatment of signs and symptoms of dry eye disease due to meibomian gland dysfunction, according to a press release.
The MOJAVE study will evaluate NOV03 (perfluorohexyloctane) in 622 subjects.
The first study, GOBI, met its primary and secondary endpoints. The phase 3 program also includes an ongoing multicenter, open-label, single-arm 12-month safety extension trial called KALAHARI.
“Completion of enrollment for the MOJAVE phase 3 study marks the next important milestone in our development of NOV03 with Novaliq,” Yolande Barnard, vice president and general manager, U.S. Pharmaceuticals, Bausch + Lomb, said in the release. “This brings us one step closer to potentially bringing forward a first-in-class treatment option to specifically treat the symptoms of dry eye disease associated with MGD.”
The companies intend to submit a new drug application for NOV03 to the FDA in 2022 if the topline results are positive.
Read more about
Click Here to Manage Email Alerts