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The phase 3 GOBI study endpoints was significantly greater with NOV03 versus hypotonic saline on the change from baseline at Week 8.
New research indicates NOV03 (perfluorohexyloctane) ophthalmic drop exhibited clinically meaningful improvements in the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).
The phase 3 GOBI trial met its primary sign endpoint of change in total corneal fluorescein staining (tCFS) score and the primary symptom endpoints of change in visual analog scale (VAS) eye dryness score, significantly favoring NOV03 over hypotonic saline.
“There are currently no FDA-approved pharmacologic treatments for DED associated with MGD, and results of this study suggest that NOV03 may potentially fill this unmet need,” wrote corresponding author Jason L. Vittitow, PhD, Bausch + Lomb.
Previous data from a phase 2 randomized controlled trial (SEECASE) showed significantly greater reduction in the signs and symptoms of DED with perfluorohexyloctane solution versus 0.9% saline and the therapy was well-tolerated. The phase 3 GOBI trial further evaluated the efficacy and safety of the drops in an eight-week, multicenter, saline-controlled study conducted at 26 investigational sites in the United States between December 2019 and March 2021.
Eligible participants met key inclusion criteria of DED in ≥1 eye at screening and randomization, including tear film break-up time ≤5 seconds, ocular surface disease index score ≥25, unanesthetized Schirmer I test ≥5 mm, total MGD score ≥3, and total corneal fluorescein staining (tCFS) score ≥4 and ≤11, according to the National Eye Institute (NEI) scale.
The study randomized patients 1:1 to receive perfluorohexyloctane ophthalmic solution or hypotonic saline solution (0.6%). They were instructed to instill 1 drop of study medication into each eye 4 times daily for 8 weeks. Signs and symptoms of DED were assessed at screening, baseline, and 3 follow up visits: Week 2 (Day 15), Week 4 (Day 29), and Week 8 (Day 57)
The primary efficacy endpoints were the change from baseline at Week 8 in tCFS score and visual analog scale (VAS) eye dryness score (0 - 100). Key secondary endpoints included the change from baseline in VAS dryness score at Week 2, tCFS score at Week 2, eye burning/stinging score at Week 8, and central corneal fluorescein staining (cCFS, 0 - 3 NEI scale) at Week 8.
The full analysis set comprised 597 patients (NOV03, n = 303; saline, n = 294). Demographic and baseline disease characteristics were considered well balanced between the treatment groups.
The findings suggest improvements from baseline to week 8 were significantly greater in those treated with NOV03 for both tCFS (least-squares [LS] mean treatment difference, -0.97; 95% CI, -1.40 to -0.55; P <.001) and VAS dryness score (LS mean treatment difference, -7.6; 95% CI, -11.8 to -3.4; P <.001). This met both primary efficacy endpoints according to investigators.
As NOV03 was statistically superior to saline for both primary endpoints, the 4 key secondary endpoints were tested hierarchically. Investigators found the mean improvement from baseline was significantly greater for NOV03 versus saline for all key secondary endpoints.
The data show the LS mean treatment difference (95% CI) was -4.7 for VAS dryness score at Week 2, -0.6 for change from baseline in tCFS score at Week 2, -5.5 for VAS burning/stinging score at Week 8, and -0.2 for change from baseline in cCFS score at Week 8 (all P <.01).
Regarding safety, the study reported ocular adverse events were experienced by 9.6% of patients in the NOV03 group and 7.5% of patients in the saline group. Ocular adverse events were considered by the investigator to be related to study medication in 6.3% and 3.1% of patients, respectively. There were no serious ocular adverse events reported in the study, while a single patient discontinued NOV03 due to eye irritation.
The study, “NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study,” was published in Ophthalmology.