NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study.

Abstract

PURPOSE:

To evaluate the efficacy and safety of NOV03 (perfluorohexyloctane) ophthalmic drop in patients with dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

DESIGN:

Eight-week, phase 3, multicenter, randomized, double-masked, saline-controlled study.

PARTICIPANTS:

Adults ≥ 18 years with a history of DED for ≥ 6 months, tear film breakup time of ≤ 5 seconds, Schirmer I test (without anesthesia) score ≥ 5 mm, MGD score ≥ 3 (0-15 scale), and total corneal fluorescein staining (tCFS) score ≥ 4 and ≤ 11 (0-15 National Eye Institute [NEI] scale).

METHODS:

Patients were randomized 1:1 to NOV03 or hypotonic (0.6%) saline 4 times daily.

MAIN OUTCOME MEASURES:

The primary sign and symptom end points were change from baseline in tCFS and eye dryness score (0-100 visual analog scale [VAS]) at week 8. Key secondary end points were change from baseline in eye dryness score at week 2, tCFS at week 2, eye burning or stinging score (0-100 VAS) at week 8, and central corneal fluorescein staining (cCFS; 0-3 NEI scale) at week 8.

RESULTS:

Of the 599 patients randomized, 597 were treated (NOV03, n = 303; saline, n = 294). At week 8, improvement from baseline was significantly greater (P < 0.001) with NOV03 versus saline for tCFS (least square [LS] mean treatment difference, -0.97; 95% confidence interval [CI]: -1.40, -0.55) and VAS dryness score (-7.6; 95% CI: -11.8, -3.4). Improvement from baseline also significantly (P < 0.01) favored NOV03 on all key secondary end points: LS mean treatment difference (95% CI) was -4.7 (-8.2, -1.2) for VAS dryness score at week 2, -0.6 (-0.9, -0.2) for tCFS at week 2, -5.5 (-9.5, -1.6) for VAS burning or stinging score at week 8, and -0.2 (-0.4, -0.1) for cCFS at week 8. Most ocular adverse events (AEs) were mild in severity; no serious ocular AEs occurred. One patient discontinued NOV03 because of an AE (eye irritation).

CONCLUSIONS:

In patients with DED associated with MGD, NOV03 demonstrated statistically significant and clinically meaningful improvements versus hypotonic saline in signs and symptoms of DED and was well tolerated.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found after the references.

• Authors: Joseph Tauber, Gregg J Berdy, David L Wirta, Sonja Krösser, Jason L Vittitow, GOBI Study Group
• Journal: Ophthalmology (Ophthalmology) Vol. 130 Issue 5 Pg. 516-524 (05 2023) ISSN: 1549-4713 [Electronic] United States
• PMID: 36574848 (Publication Type: Randomized Controlled Trial, Clinical Trial, Phase III, Multicenter Study, Journal Article)
• Copyright: Copyright © 2023 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Fluorescein
• Ophthalmic Solutions

Topics

• Adult
• Humans
• Meibomian Gland Dysfunction
• Fluorescein
• Dry Eye Syndromes (diagnosis, drug therapy, etiology)
• Double-Blind Method
• Ophthalmic Solutions
• Tears
• Meibomian Glands