Bausch + Lomb, the global eye health business of Bausch Health Companies Inc. (BHC,BHC.TO), and Novaliq GmbH reported statistically significant topline data from the second phase 3 trial evaluating the investigational drug NOV03 to treat the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction. The company said the findings from this second phase 3 trial reinforces the results of the first phase 3 trial and further supports the efficacy and safety profile of NOV03.
The clinical development program for NOV03 is anticipated to conclude with an ongoing multi-center, open-label, single-arm, 12-month safety extension trial. The companies anticipate filing a New Drug Application to the FDA in 2022.
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