Efficacy of perfluorohexyloctane ophthalmic solution in patients with dry eye disease stratified by baseline severity

Abstract

Purpose : Perfluorohexyloctane ophthalmic solution (PFHO, 100%) is a water-free, preservative-free, topical ophthalmic drop indicated for treatment of the signs and symptoms of dry eye disease (DED). We performed a post-hoc analysis of pivotal clinical trial data to determine the efficacy of PFHO in patients with DED stratified by baseline disease severity.

Methods : Data were pooled from two phase 3, randomized, double-masked, hypotonic saline-controlled clinical trials. Enrolled patients had self-reported DED and clinical signs that included total corneal fluorescein staining (tCFS) score of ≥4 and ≤11 (National Eye Institute scale; range, 0-15), Meibomian gland dysfunction (MGD) score of ≥3 (based on secretions from 5 central Meibomian glands on the lower eyelid; score range, 0-15), and unanesthetized Schirmer I test result of ≥5 mm. Study medication (PFHO or saline [0.6%] solution) was instilled QID in both eyes for 8 weeks. The primary study endpoints were change from baseline at Week 8 in tCFS score (in the designated study eye) and patient-reported eye dryness score, measured on a visual analog scale (VAS; 0-100). The proportion of responders was calculated for tCFS (improvement of ≥3 points) and eye dryness VAS score (improvement of ≥30%). In the present analysis, the primary endpoints and response rates were evaluated in patient subgroups stratified by baseline score for tCFS (<7 or ≥7), MGD score (<7 or ≥7), or Schirmer I test (<10 or ≥10 mm).

Results : The analysis population included 1216 patients (PFHO, n=613; saline, n=603). In every patient subgroup evaluated, improvements from baseline in the primary sign (tCFS score) and primary symptom (eye dryness VAS score) endpoints were significantly greater with PFHO versus saline (Table 1). Similarly, response rates were significantly higher for PFHO compared with saline in all patient subgroups (Table 2).

Conclusions : Results of the post-hoc analysis indicate that PFHO is efficacious in the treatment of signs and symptoms of DED in patients with mild or moderate disease.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.