Bausch + Lomb, Novaliq announce publication of Phase 3 data on NOV03

Bausch + Lomb and Novaliq GmbH announced that American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03. NOV03 is being investigated to treat the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction. Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The U.S. Food and Drug Administration assigned NOV03 a Prescription Drug User Fee Act action date of June 28, 2023. The two primary endpoints were change from baseline at Week 8 in total corneal fluorescein staining and eye dryness Visual Analog Scale score. Key secondary endpoints included change from baseline in eye dryness VAS score and tCFS at Week 2 (Day 15 +/- 1) and eye burning/stinging VAS score and central corneal fluorescein staining at Week 8. Significant improvements vs. hypotonic saline solution were seen as early as day 15. Data highlights include: Primary endpoints: At Week 8, reduction from baseline in tCFS was statistically greater in the NOV03 arm compared to the control saline group. At Week 8, VAS dryness score was statistically significantly improved in the NOV03 arm compared to control group. Key secondary endpoints: At Week 2, tCFS and VAS dryness score were statistically significant compared to saline, with an LS mean treatment difference for change from baseline in tCFS of -0.6 and VAS score of -7.8. At Week 8 VAS burning/stinging score and cCFS also favored the NOV03 group, with an LS mean treatment difference for change from baseline in VAS burning/stinging score of -7.3.