FDA Accepts Bausch + Lomb/Novaliq's New Drug Application For NOV03; Decision Due On June 28

(RTTNews) - Bausch + Lomb Corp. (BLCO), a Canadian eye care products supplier, and Novaliq GmbH, an ocular therapeutics provider, on Tuesday said that the U.S. Food and Drug Administration has accepted their New Drug Application for NOV03 eye drop.

NOV03 is proposed for the treatment of signs and symptoms of dry eye disease associated with Meibomian gland dysfunction. The FDA's decision date is set for June 28, 2023.

As of now, there is no approved prescription eye drop in the U.S. for dry eye disease associated with Meibomian gland dysfunction.

Joseph Papa, CEO of Bausch + Lomb, said: "NOV03 is distinct from anti-inflammatory and immunomodulatory agents, and, if approved, would be the first prescription eye drop to address excessive tear evaporation. 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."