Bausch + Lomb Submits NDA For Dry Eye Disease Therapy

Bausch + Lomb and Novaliq have submitted a new drug application (NDA) to the FDA seeking approval for NOV03 (perfluorohexyloctane), an investigational treatment for patients with dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).

Perfluorohexyloctane 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.

Joseph C. Papa

“If approved by the FDA, NOV03 will be the first available therapy indicated to address the signs and symptoms for this patient population,” Joseph C. Papa, chairman and CEO, Bausch + Lomb, said in a press release. “The NOV03 filing is an example of the commitment of Bausch + Lomb toward bringing novel treatment options to the industry so that we can better serve patients.”

(Editor’s note: Bausch + Lomb in May 2022 finalized its separation from Bausch Health Companies and began trading as a separate company.)

The therapy met both primary endpoints in two pivotal phase 3 trials of total corneal fluorescein staining, a measure that assesses damage to the eye, and visual analogue scale dryness score at day 57. Results for the GOBI trial were presented at the annual meeting of the 2022 American Society for Cataract and Refractive Surgery (ASCRS) held in Washington, D.C., in April 2022.

Results from the MOJAVE trial were presented virtually at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in May 2022.

The GOBI study was based on results from 597 participants ages 18 years and older who were randomized to either receive treatment with NOV03 four times daily or saline solution four times daily.

On day 57, change from baseline in total corneal fluorescein staining (tCFS) was statistically significant in the NOV03 arm compared with the control saline group. Fluorescein staining is a test that uses orange dye and blue light to detect anything foreign in the eye, as well as damage to the cornea.

Additionally on day 57, eye dryness visual analog scale (VAS) score—which tests pain—was statistically significantly improved in the NOV03 arm compared with the control group. tCFS and eye dryness VAS score was also statistically significant at day 15 (secondary endpoint).

In the study, NOV03 was well tolerated with few patients experiencing ocular side effects. Blurred vision, mostly mild and transient, was the only side effect that occurred in a higher proportion of subjects treated with NOV03.

In the MOJAVE trial, the data were based on results from 620 patients 18 years and older who were randomized to either receive treatment with NOV03 four times daily or hypotonic saline solution four times daily. At day 57, change from baseline in tCFS was statistically significant. Additionally on day 57, VAS eye dryness score was statistically significantly improved in the NOV03 arm compared to control group.

In MOJAVE, 9.6% of patients in the NOV03 group experienced ocular side effects.

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.