Treatment with perfluorohexyloctane eye drops can offer clinically meaningful improvements in both the signs and symptoms of dry eye disease compared with hypotonic saline in patients with meibomian gland dysfunction, according to research published in Ophthalmology. Perfluorohexyloctane is being investigated under the name NOV03 (Bausch + Lomb).
Investigators conducted a multicenter, randomized, double-masked, saline-controlled phase 3 study to evaluate the efficacy and safety of the NOV03 ophthalmic drop in adult patients with dry eye disease associated with meibomian gland dysfunction (ClinicalTrials.gov Identifier: NCT04139798).
The investigators enrolled patients with a history of dry eye disease for 6 months or longer, tear film breakup time of 5 seconds or less, Schirmer I test (without anesthesia) score of 5 mm or higher, meibomian gland dysfunction score of 3 or higher (0-15 scale), and total corneal fluorescein staining (tCFS) score of 4 or higher and 11 or lower (0-15 National Eye Institute scale). Patients were randomly assigned to receive the NOV03 or hypotonic (0.6%) saline drop 4 times daily.
The team assessed a primary sign endpoint, change in tCFS from baseline to week 8, and primary symptom endpoint, change in eye dryness score (0-100 visual analog scale [VAS]) from baseline to week 8.
A total of 597 patients were treated on study, 303 in the NOV03 group (mean age, 60.3 years; 72.3% women and 27.7% men) and 294 in the saline group (mean age, 61.6 years; 72.8% women 27.2% men).
The investigators found improvement from baseline to week 8 was significantly greater in the NOV03 group than in the saline group for both tCFS (least-squares [LS] mean treatment difference, -0.97; 95% confidence interval [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). In fact, the investigators report that VAS dryness scores (-0.6 [-0.9, -0.2]) and tCFS (-5.5 [-9.5, -1.6]) were both changed from baseline by week 2.
The investigators also report drug-related ocular adverse events (AEs) in 6.3% of the NOV03 group and 3.1% of the saline group. Most ocular adverse events were mild in severity.
“There are currently no FDA-approved pharmacologic treatments for DED associated with MGD, and results of this study suggest that NOV03 may potentially fulfill this unmet need,” according to the investigators.
Limitations of the study included the relatively short treatment period and exclusion of patients with severe dry eye.
Disclosure: This research was supported by Bausch + Lomb. Please see the original reference for a full list of disclosures.
Tauber J, Berdy GJ, Wirta DL, Krösser S, Vittitow JL; on behalf of the GOBI Study Group. NOV03 for dry eye disease associated with meibomian gland dysfunction: results of the randomized phase 3 GOBI study. Ophthalmol. Published online December 24, 2022. doi:10.1016/j.ophtha.2022.12.021
This article originally appeared on Ophthalmology Advisor