Results from phase III GOBI trial for NOV 03 in Dry eye disease published in Opthalmology
Bausch + Lomb Corp and Novaliq GmbH announced that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the pivotal Phase III trial GOBI, which is one of two pivotal Phase III trials for NOV03 (perfluorohexyloctane)
NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.
The data from the Phase III, multicenter, randomized, hypotonic saline-controlled, double masked GOBI study was based on results from 597 subjects aged 18 years and older who were randomized to either receive treatment with NOV03 four times daily or hypotonic saline solution four times daily (n=303 NOV03; n=294 saline). The two primary endpoints were change from baseline at Week 8 (Day 57 ± 2) in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) 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 (cCFS) at Week 8. Significant improvements vs. hypotonic saline solution were seen as early as day 15.
At Week 8, change from baseline in tCFS was statistically significantly greater in the NOV03 arm compared to the control saline group (least-squares [LS] mean treatment difference, -0.97; (95% confidence interval [CI]: -1.40 vs. -0.55) (P<0.001)). at week 8, eye dryness vas score was statistically significantly improved in the nov03 arm compared to control group (ls mean treatment difference, -7.6; (95% ci: -11.8 vs. -3.4) (p><0.001). at week 2 (day 15), tcfs and eye dryness vas score were statistically significant compared to saline, with an ls mean treatment difference (95% ci) for change from baseline in tcfs of -0.6 (-0.9, -0.2) (p><0.01) and vas score of -4.7 (-8.2, -1.2) (p><0.01). in the study, nov03 was well tolerated with few subjects experiencing ocular adverse events (aes) (9.6% nov03 group, 7.5% control group) or treatment-related ocular aes (6.3% nov03 group, 3.1% control group).></0.01).></0.01)></0.001).></0.001)).>