Perfluorohexyloctane Ophthalmic Solution for Dry Eye Disease: Pooled Analysis of Two Phase 3 Clinical Trials

Theme: Cornea, external disease & refractive surgery
What: Cornea, external disease & refractive surgery
Part of: Cornea II: Medical Cornea and Ocular Surface / Cornée II: Cornée médicale et surface oculaire
When: 5/31/2024, 02:00 PM - 03:30 PM
Where: Room | Salle 713 AB

Abstract

Purpose: Perfluorohexyloctane ophthalmic solution (PFHO) is approved in the United States for treatment of the signs and symptoms of dry eye disease (DED). This analysis evaluated the integrated safety and efficacy of PFHO across two clinical trials.

Study design: Pooled analysis of data from two phase 3, randomized, double-masked, hypotonic saline-controlled trials.

Methods: Patients with DED and clinical signs of Meibomian gland dysfunction were randomly assigned to instill PFHO or hypotonic (0.6%) saline solution QID into both eyes for 8 weeks. The primary sign endpoint was change in total corneal fluorescein staining (tCFS; National Eye Institute [NEI] scale, 0-15) at Week 8 in the designated study eye. The primary symptom endpoint was change in patient-reported eye dryness measured on a visual analog scale (VAS; 0-100) at Week 8. Responder analyses were conducted for the primary endpoints, with response defined as reduction in tCFS of ≥3 points on the NEI scale and reduction in eye dryness of ≥30% on the VAS scale. Key secondary endpoints were tCFS at Week 2, VAS dryness score at Week 2, central CFS at Week 8, and VAS burning/stinging score at Week 8.

Results: A total of 614 patients received PFHO; 603 patients received saline. The majority of patients were female (75.7%); mean age was 57.2 years. Mean (SD) decrease in tCFS at Week 8 was -2.2 (2.7) with PFHO and -1.1 (2.8) with saline (P<0.0001). Mean (SD) decrease in VAS dryness score at Week 8 was -28.5 (28.2) with PFHO and -19.3 (27.0) with saline (P<0.0001). The proportion of tCFS responders at Week 8 was 45.7% in the PFHO group and 29.0% in the saline control group (odds ratio, 2.1; 95% CI, 1.66-2.73; P<0.0001). The proportion of eye dryness responders at Week 8 was 61.6% and 45.9%, respectively (odds ratio, 1.9; 95% CI, 1.50-2.39; P<0.0001). PFHO was superior to saline on all key secondary endpoints (all P<0.0001). Incidence of ocular adverse events in the study eye was 11.2% with PFHO and 10.0% with hypotonic saline. Blurred vision, which was mostly mild and transient, was the most common ocular adverse event with PFHO (2.1% of patients vs 0.3% for saline). Other safety assessments (eg, visual acuity, biomicroscopy, fundoscopy, intraocular pressure) were unremarkable.

Conclusions: The combined safety and efficacy data from this pooled analysis demonstrated that PFHO was well tolerated and efficacious for improving both the signs and symptoms of DED.

Presenter(s)

Presenting Author: Clara Chan

Additional Author(s):

Ahmad Fahmy, Minnesota Eye Consultants

David Evans, Total Eye Care, PA

Jennifer Harthan, Illinois College of Optometry

Joanne Gourgouvelis, Bausch + Lomb

Kathleen Kelley, Price Vision Group

Jason Vittitow, Bausch + Lomb

Jack Greiner, Clinical Eye Research of Boston

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