FDA Accepts NDA for Novel Dry Eye Disease Therapy

The FDA has accepted Bausch + Lomb’s new drug application (NDA) for NOV03 (perfluorohexyloctane) associated with Meibomian gland dysfunction (MGD). The therapy is a first-in-class eye drop with a novel mechanism of action. It prevents excessive tear evaporation and has the ability to restores tear film balance. It stabilizes the lipid layer for hours to protect the tear film and has the ability to penetrate the Meibomian glands. NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

“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, Bausch + Lomb, said in a press 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.”

In May 2022, Bausch + Lomb in finalized its separation from Bausch Health Companies and began trading as a separate company.

Bausch + Lomb submitted the NDA for NOV03 in July 2022 based on two pivotal phase 3 trials, (GOBI and MOJAVE), both of which demonstrated statistically significant improvement vs. control for both primary and key secondary sign and symptom endpoints as early as day 15 and through day 57. NOV03 was well tolerated in both studies.

Related: Bausch + Lomb Submits NDA For Dry Eye Disease Therapy

Dry eye disease is one of the most common ocular surface disorders, causing discomfort for about 18 million Americans. Meibomian gland dysfunction is a major cause of the development and progression of evaporative dry eye disease, which is caused by a deficient tear film lipid layer that leads to increased tear evaporation.

In December 2019, Bausch acquired an exclusive license for the commercialization and development in the United States and Canada of NOV03 from Novaliq. NOV03 uses Novaliq’s water-free, preservative-free solution based on EyeSol technology.