PURPOSE: Perfluorohexyloctane ophthalmic solution (PFHO; MIEBO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). This post hoc analysis assessed the efficacy of PFHO among patients with DED and cataract in the GOBI and MOJAVE pivotal studies.

METHODS: GOBI and MOJAVE were phase 3, randomized, hypotonic saline–controlled, 8-week clinical studies evaluating the efficacy and safety of PFHO dosed four times a day in participants ≥18 years with DED. Primary endpoints were change from baseline in total corneal fluorescein staining (tCFS) score (National Eye Institute scale, 0-15) and eye dryness visual analog scale (VAS) score (0-100). In this analysis, data for these endpoints were pooled and evaluated using an analysis of covariance among patients categorized into subgroups of patients with concomitant cataract and patients without cataract (or pseudophakia).

RESULTS: Of 1217 patients overall (n=614 PFHO; n=603 saline), there were 411 patients with cataract and 667 without cataract. Consistent with overall population, reductions (ie, improvements) in tCFS and eye dryness scores were significantly greater for PFHO compared with the control treatment in both subgroups. At Week 8, least-squares (LS) mean change from baseline in tCFS score for PFHO vs control group was 1.9 vs 0.9 (P=0.0003) for patients with cataract and 2.5 vs 1.3 (P<0.0001) for patients without cataract. for eye dryness vas score ls mean change from baseline in pfho vs control group was 28.0 vs 19.3 p="0.0015)" for patients with cataract and 29.3 vs 19.4 p><0.0001) for patients without cataract. improvements in tcfs and eye dryness scores were also observed at week 2: ls mean change in pfho vs control group was -1.4 vs -0.9 p="0.03)" in patients with cataract and -2.0 vs -1.4 p="0.0004)" in patients without cataract for tcfs and -18.6 vs -15.3 p="0.14)" and -18.6 vs -10.0 p><0.0001), respectively for eye dryness.>

CONCLUSIONS: PFHO was effective in improving signs and symptoms of DED in patients with DED and concomitant cataract. These data support that PFHO may be a promising treatment option for preoperative management of patients with DED undergoing cataract surgery, warranting further study in this patient population.