FDA Accepts New Drug Application for NOV03 Dry Eye Treatment

FDA Accepts New Drug Application for NOV03 Dry Eye Treatment

September 08, 2022

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for NOV03 (perfluorohexyloctane) for the treatment of the signs and symptoms of dry eye disease, according to a joint press release from Bausch + Lomb and Novaliq.

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).

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

"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.

About NOV03 (perfluorohexyloctane) Ophthalmic Solution

NOV03 (perfluorohexyloctane) is an investigational, proprietary, water-free, non-steroidal, single-component preservative-free eye drop.4 In 2019, Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the United States and Canada. Data from the first pivotal Phase 3 trial (GOBI) were presented at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Washington, D.C. on April 24, 2022.

Data from the second pivotal Phase 3 trial (MOJAVE) were presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver on May 2, 2022. Results from the pivotal Phase 2 trial (SEECASE) were published in Cornea in September 2021.5 The clinical program for NOV03 concluded with the completion of a multi-center, open-label, single-arm, 12-month safety extension trial (KALAHARI).