FDA accepts new drug application for NOV03 dry eye treatment


06 September 2022

1 minute read

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The FDA has 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 nonsteroidal waterless eye drop for dry eye associated with meibomian gland dysfunction. Positive results from the pivotal Phase 3 GOBI and MOJAVE trials were announced earlier this year.

white and blue panel with the FDA logo affixed

Source: Adobe Stock.

“NOV03 is distinct from anti-inflammatory and immunomodulatory agents and, if approved, would be the first prescription eye drop to combat excessive tear evaporation” Joseph C. Papa, CEO of Bausch + Lomb, said in the statement. “The approval would also mark a significant milestone for Bausch + Lomb, as the company’s first FDA approval for a prescription drug since becoming a public company earlier this year.”

NOV03 received an action date under the Prescription Drug User Fees Act of June 28, 2023.

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