Long-Term Safety and Efficacy of Perfluorohexyloctane Ophthalmic Solution for the Treatment of Patients With Dry Eye Disease: The KALAHARI Study

Abstract

Purpose: The aim of this study was to assess the long-term safety and efficacy of perfluorohexyloctane (PFHO) ophthalmic drop (formerly NOV03) for treatment of dry eye disease (DED). Methods: KALAHARI was a phase 3, multicenter, single-arm, open-label extension study in patients aged 18 years or older with DED associated with Meibomian gland dysfunction who completed the randomized, double-masked, hypotonic saline-controlled GOBI study. Patients instilled 1 drop of PFHO (MIEBO, Bausch + Lomb) 4 times daily in both eyes for 52 weeks. Safety assessments included adverse events, best-corrected visual acuity, slit-lamp biomicroscopy, intraocular pressure, and dilated fundoscopy. Efficacy end points included change from GOBI study baseline in total corneal fluorescein staining and eye dryness score (0–100 visual analog scale). Results: Overall, 208 patients from GOBI (PFHO [n = 97]; saline [n = 111]) were rolled over into KALAHARI. Twenty-nine patients (13.9%) had ≥1 ocular adverse event, with most being mild or moderate in severity; the most common ocular adverse events were vitreous detachment (1.9%), allergic conjunctivitis (1.4%), blurred vision (1.4%), and increased lacrimation (1.4%). Other safety end points were unremarkable. For patients continuing PFHO from GOBI, improvements in total corneal fluorescein staining and visual analog scale dryness scores observed in GOBI were maintained throughout KALAHARI. Patients treated with saline in GOBI and switched to PFHO in KALAHARI showed improvements in total corneal fluorescein staining and visual analog scale scores by week 4 that were maintained for the rest of the study. Conclusions: PFHO was safe and well tolerated and maintained efficacy for improving signs and symptoms of DED in this year-long study of patients with DED associated with Meibomian gland dysfunction.

Recent Advances in the Treatment of Ocular Complications of Rheumatoid Arthritis: A review of current literature

“…Two Phase III clinical trials (GOBI [ClinicalTrials.gov identifier: NCT04139798] and MOJAVE [ClinicalTrials.gov identifier: NCT04567329]) have shown a consistent improvement of two primary endpoints (tCFS and dryness scores), demonstrating a safety profile similar to that of hypotonic saline solution [21,22]. The most recent phase III open-label extension study (KALAHARI [ClinicalTrials.gov identifier: NCT04140227]), revealed that improvement in both tCFS and dryness scores was maintained in the PFHO group and the drug was deemed safe [23]. Other studies further corroborate its efficacy in ameliorating DED symptoms with satisfactory tolerability and excellent patient satisfaction [24,25].…”