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Bausch + Lomb Announce U.S. FDA Filing Acceptance for NOV03

PDUFA action date is June 28, 2023.




(PRESS RELEASE) VAUGHAN, ONTARIO AND HEIDELBERG, GERMANY — Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

“With the FDA commencing review of the NDA filing, we are one step closer to bringing an important new treatment option to the millions of Americans affected by dry eye disease associated with Meibomian gland dysfunction,” said Joseph C. Papa, CEO, Bausch + Lomb. “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.”

DED is one of the most common ocular surface disorders, with MGD as a major cause of development and progression, affecting approximately nine out of 10 people with DED.1,2 DED due to MGD is caused by a deficient tear film lipid layer that leads to increased tear evaporation.3 There is currently no approved prescription eye drop in the United States for DED associated with MGD.

“We are thrilled the FDA has accepted our NDA filing for NOV03,” said Christian Roesky, Ph.D., CEO, Novaliq. “With only limited treatment options currently available, NOV03 is a promising potential new therapy, specifically designed to alleviate the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction.”

The clinical development program for NOV03 includes two Phase 3 studies (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.



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