Bausch + Lomb Completes Enrollment of Second Phase 3 Study for NOV03

Bausch + Lomb and Novaliq announced the second of two phase 3 (MOJAVE) studies evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD), has been completely enrolled with a total of 622 participants. 

“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 a company news 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 phase 3 program for NOV03 also includes a previous phase 3, multicenter, randomized, double-masked, saline-controlled trial (GOBI), for which the companies announced statistically significant topline results in April 2021, and an ongoing multicenter, open-label, single-arm 12-month safety extension trial (KALAHARI). 

“We are very pleased with the progress of the phase 3 program for NOV03. We are hopeful the results of the MOJAVE study will be consistent with the results of the GOBI trial and reconfirm all efficacy and safety results from the earlier phases of the development program for NOV03,” said Christian Roesky, PhD, CEO, Novaliq. 

If the topline results are positive, the companies plan to submit a new drug application for NOV03 to the FDA in 2022. 

About NOV03 (perfluorohexyloctane) Ophthalmic Solution

NOV03 is an investigational, proprietary, water-free and preservative-free solution, based on patented EyeSol technology from Novaliq GmbH. In 2019, Bausch Health and Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the United States and Canada. In addition to the phase 3 program, in January 2021, the companies announced the results from a phase 2 clinical study (SEECASE) evaluating NOV03 were published in Cornea: The Journal of Cornea and External Disease.