FDA accepts new drug application for NOV03 dry eye treatment
The FDA accepted a new drug application for NOV03, an investigational treatment for the signs and symptoms of dry eye disease, according to a press release from Bausch + Lomb and Novaliq.
NOV03 (perfluorohexyloctane) is a water-free nonsteroidal eye drop for dry eye associated with meibomian gland dysfunction. Positive results from the pivotal phase 3 GOBI and MOJAVE trials were reported earlier this year.
“NOV03 is distinct from anti-inflammatory and immunomodulatory agents and, if approved, would be the first prescription eye drop to address excessive tear evaporation” Joseph C. Papa, CEO of Bausch + Lomb, said in the release. “The approval would also mark a significant milestone for Bausch + Lomb, as the company’s first FDA approval for a prescription medicine since becoming a publicly traded company earlier this year.”
NOV03 received a prescription drug user fee act action date of June 28, 2023.
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