FDA accepts NDA of NOV03 for DED associated with MGD

Bausch + Lomb and Novaliqu announced that the FDA has accepted its New Drug Application for NOV03, an investigational treatment for dry eye disease associated with meibomian gland dysfunction.


The FDA has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane), Bausch + Lomb Corp. and Novaliq GmbH announced on Monday.

As 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). It functions as a proprietary, water-free, non-steroidal, single-component preservative-free eye drop.

NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

According to Bausch + Lomb's CEO Joseph C. Papa, the company is now 1 step closer to bringing an important new treatment option to the millions of Americans affected by DED associated with MGD.

“NOV03 is distinct from anti-inflammatory and immunomodulatory agents, and, if approved, would be the first prescription eye drop to address excessive tear evaporation,” Papa stated, in a news release.

Further, Papa stated that the approval would also mark a significant milestone for Bausch + Lomb, as the its first FDA approval for a prescription medicine since becoming a publicly traded company earlier this year.

Per the release, 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.

Background

In 2019, Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the US 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, DC, 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 2021.1

The clinical program for NOV03 concluded with the completion of a multi-center, open-label, single-arm, 12-month safety extension trial (KALAHARI).

References

  1. Tauber J, Wirta DL, Sall K, Majmudar PA, Willen D, Krösser S; SEECASE study group. (2021). A randomized clinical study (SEECASE) to assess efficacy, safety, and tolerability of NOV03 for treatment of dry eye disease. Cornea;40(9):1132-1140. http://doi.org/10.1097/ICO.0000000000002622.