Perfluorohexyloctane (PFHO), 100%, is a water- and preservative-free lubricant indicated for the treatment of the signs and symptoms of dry eye disease. Although the exact mechanism of action of PFHO is unknown, it is thought to form a monolayer at the air-liquid interface of the tear film, which is expected to stabilize the natural tear film and reduce evaporation.1,2

Approval of PFHO for treating dry eye disease was supported by the results of two phase 3 multicenter, double-masked, controlled clinical trials—GOBI and MOJAVE—that enrolled a total of 1219 patients with DED and clinical signs of meibomian gland dysfunction.1,2 Both studies met their coprimary end points, showing statistically significant differences favoring PFHO over hypotonic saline in analyses of change from baseline to week 8 in total corneal fluorescein staining and in the Visual Analogue Scale eye dryness score (Figure 1).1,2 Safety data showed PFHO was well tolerated. In the PFHO groups, drug-related ocular adverse events (AEs) occurred in 6.3% of 303 patients in GOBI and in 6.4% of 311 patients in MOJAVE. Most AEs were mild or moderate and transient. Only 1 patient discontinued treatment because of an AE (severe eye irritation). Blurred vision was the only ocular AE in the PFHO groups, occurring at a rate ≥ 1.6%.

Figure 1. Pivotal trials investigating perfluorohexyloctane, 100%, met their coprimary efficacy end points1,2

Abbreviations: PFHO, perfluorohexyloctane; SE, standard error; tCFS, total corneal fluorescein; VAS, Visual Analogue Scale.

Results of the 52-week open-label KALAHARI study reinforced the efficacy and safety of PFHO.3 Patients who completed GOBI were eligible for KALAHARI, in which all participants used PFHO 4 times daily. Patients who were treated with saline in GOBI had improvements in total corneal fluorescein staining and eye dryness by 4 weeks, both of which were maintained throughout follow-up (Figure 2).3

Figure 2. Patients treated with saline in GOBI and switched to perfluorohexyloctane in KALAHARI showed improvements in total corneal fluorescein staining (A) and eye dryness (B) scores by week 4 that were maintained to week 523

Abbreviations: PFHO, perfluorohexyloctane; SEM, standard error of the mean; tCFS, total corneal fluorescein; VAS, Visual Analogue Scale.

References

  1. Tauber J, Berdy GJ, Wirta DL, Krösser S, Vittitow JL; GOBI Study Group. NOV03 for dry eye disease associated with meibomian gland dysfunction: results of the randomized phase 3 GOBI study. Ophthalmology. 2023;130(5):516-524.
  2. Sheppard JD, Kurata F, Epitropoulos AT, Krösser S, Vittitow JL; MOJAVE Study Group. NOV03 for signs and symptoms of dry eye disease associated with meibomian gland dysfunction: the randomized phase 3 MOJAVE study. Am J Ophthalmol. 2023;252:265-274.
  3. Protzko EE, Segal BA, Korenfeld MS, Krösser S, Vittitow JL. Long-term safety and efficacy of perfluorohexyloctane ophthalmic solution for the treatment of patients with dry eye disease: the KALAHARI study. Cornea. Accepted manuscript. Published online November 3, 2023. doi:10.1097/ICO.0000000000003418.

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