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 in 3 groups: patients without cataract (or pseudophakia), patients with concomitant cataract, and patients with pseudophakia.

RESULTS: Of 1217 patients overall (n=614 PFHO; n=603 saline), there were 667 patients without cataract, 411 with cataract, and 139 with pseudophakia. Consistent with overall population, reductions (ie, improvements) in tCFS and eye dryness scores were greater for PFHO vs control in all 3 subgroups. At Week 8, least-squares mean reductions from baseline in PFHO/control groups for tCFS were 2.5/1.3 (P<0.0001), 1.9 0.9 p="0.0003)," and 1.1 0.5 p="NS)" for patients without cataract with cataract and with pseudophakia respectively and for eye dryness were 29.3 19.4 p><0.0001), 28.0 19.3 p="0.0015)," and 26.2 21.1 p="NS)" for patients without cataract with cataract and with pseudophakia respectively.>

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.