The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for NOV03 (perfluorohexyloctane) for the treatment of signs and symptoms of dry eye associated with meibomian gland dysfunction.
NOV03 is an experimental non-steroidal eye drop, without water or preservatives. The NDA is supported by data from the Phase 3 studies GOBI (ClinicalTrials.gov Identifier: NCT04139798) and MOJAVE (ClinicalTrials.gov Identifier: NCT04567329), which evaluated the efficacy and safety of NOV03 ophthalmic solution in a total of 1,217 18-year-old adults. age and older with dry eye disease. Patients were randomized 1:1 to receive either NOV03 or hypotonic saline 4 times daily.
The co-primary endpoints for both studies were change from baseline to day 57 in total corneal fluorescein staining (tCFS), as assessed by the National Eye Institute (NEI) scale, and dryness score, as assessed on a visual analog scale (VAS).
The results demonstrated a statistically significant improvement in tCFS at day 57 in the NOV03 arm compared to the saline arm in both GOBI groups (-2.0 [2.6] versus -1.0 [2.7]respectively; P <.001) and MOJAVE (-2.3 [2.8] against -1.1 [2.9]respectively; P <.001) studies.
Additionally, NOV03 was associated with a statistically significant improvement in the VAS dry eye score at day 57 compared to saline in both GOBI tests (-27.4 [27.9] against -19.7 [26.6]respectively; P <.001) and MOJAVE (-29.5 [28.6] against -19.0 [27.2]respectively; P <.001) studies. Statistically significant improvements in dry eye score tCFS and VAS were also observed at day 15 (secondary endpoint). The most frequently reported adverse event with NOV03 was blepharitis.
“NOV03 is distinct from anti-inflammatory and immunomodulatory agents and, if approved, would be the first prescription eye drop to combat excessive tear evaporation,” said Joseph C. Papa, CEO of Bausch + Lomb.
A Prescription Drug User Fee Act target date of June 28, 2023 has been set for enforcement.
- Bausch + Lomb and Novaliq Announce Acceptance of US FDA Filing for Investigational Treatment NOV03 (perfluorohexyloctane). Press 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 the first pivotal Phase 3 trial of investigational treatment NOV03 at the ASCRS annual meeting. Press 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 the second pivotal Phase 3 trial of investigational treatment NOV03 (perfluorohexyloctane) at the Association for Research in Vision and Ophthalmology Annual Meeting. Press 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-annual-meeting-of-the-association-for-research-in-vision-and-ophthalmology/