The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for NOV03 (perfluorohexyloctane) for the treatment of the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction.
NOV03 is an investigational, water- and preservative-free nonsteroidal eye drop. The NDA is supported by data from the phase 3 GOBI (ClinicalTrials.gov Identifier: NCT04139798) and MOJAVE (ClinicalTrials.gov Identifier: NCT04567329) studies, which evaluated the efficacy and safety of NOV03 ophthalmic solution in a total of 1217 adults 18 years of age and older with dry eye disease. Patients were randomly assigned 1:1 to receive either NOV03 or hypotonic saline solution 4 times daily.
The coprimary endpoints for both studies were the change from baseline to day 57 in total corneal fluorescein staining (tCFS), as assessed by the National Eye Institute (NEI) scale, and in Dryness Score, as assessed on a visual analogue scale (VAS).
Findings demonstrated a statistically significant improvement in tCFS at day 57 in the NOV03 arm compared with the saline arm in both the GOBI (-2.0 [2.6] vs -1.0 [2.7], respectively; P <.001) and MOJAVE (-2.3 [2.8] vs -1.1 [2.9], respectively; P <.001) studies.
Additionally, NOV03 was associated with a statistically significant improvement in VAS eye dryness score on day 57 vs saline in both the GOBI (-27.4 [27.9] vs -19.7 [26.6], respectively; P <.001) and MOJAVE (-29.5 [28.6] vs -19.0 [27.2], respectively; P <.001) studies. Statistically significant improvements in tCFS and VAS eye dryness score were also observed at day 15 (secondary endpoint). The most common adverse event reported with NOV03 was blepharitis.
“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.
A Prescription Drug User Fee Act target date of June 28, 2023 has been set for the application.
- Bausch + Lomb and Novaliq announce US FDA filing acceptance for investigational treatment NOV03 (perfluorohexyloctane). News release. Bausch + Lomb Corporation and Novaliq GmbH. Accessed September 6, 2022. https://www.prnewswire.com/news-releases/bausch–lomb-and-novaliq-announce-us-fda-filing-acceptance-for-investigational-treatment-nov03-perfluorohexyloctane-301617943.html
- Bausch + Lomb presents data from first pivotal phase 3 trial of investigational treatment NOV03 at ASCRS Annual Meeting. News release. Bausch + Lomb Corporation and Novaliq GmbH. April 25, 2022. Accessed September 6, 2022. https://www.novaliq.com/press-releases/2022/04/27/bausch-lomb-presents-data-from-first-pivotal-phase-3-trial-of-investigational-treatment-nov03-at-ascrs-annual-meeting/
- Bausch + Lomb presents data from second pivotal phase 3 trial of investigational treatment NOV03 (perfluorohexyloctane) at the Association for Research in Vision and Ophthalmology Annual Meeting. News release. Bausch + Lomb Corporation and Novaliq GmbH. May 3, 2022. Accessed September 6, 2022. https://www.novaliq.com/press-releases/2022/05/03/bausch-lomb-presents-data-from-second-pivotal-phase-3-trial-of-investigational-treatment-nov03-perfluorohexyloctane-at-the-association-for-research-in-vision-and-ophthalmology-annual-meeting/