Drug submission of the first water-free therapy took place at the end of June, according to the companies.
Bausch + Lomb Corporation and Novaliq GmbH have submitted a New Drug Application (NDA) to the FDA for the investigational treatment NOV03 (perfluorhexyloctane), the companies announced Thursday. The application submission took place at the end of last month.
As a propriety, water-free, single-component preservative-free eye drop, NOV03 is designed to treat the signs and symptoms of meibomian gland dysfunction (MGD)-associated dry eye disease (DED).
Data from the first pivotal Phase 3 trial evaluating NOV03 (titled “GOBI”) was recently presented at the American Society of Cataract and Refractive Surgery (ASCRS) in Washington, DC, according to the release.
Data from the second pivotal phase 3 trial (titled “MOJAVE”) was recently presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in May.
Further, results from the pivotal Phase 2 trial (titled “SEECASE”) were published in the September 2021 issue of Cornea.
The clinical program for NOV03 ended with the completion of a multi-center, open-label, single-arm, 12-month safety extension trial (titled “KALAHARI”), according to the release.
If approved by the FDA, NOV03 would be the first available therapy indicated to address the signs and symptoms for patients with DED associated with MGD, according to Joseph C. Papa, Bausch + Lomb’s chairman and CEO, in a July 7 news release.
"This [NDA] submission is a critical milestone and the first drug submission of a water-free therapy,” said Novaliq CEO Christian Roesky, PhD, in the release. “We are excited to unfold the full potential of NOV03 by bringing this novel drug option for this condition to the [US]."