Long-term use of perfluorohexyloctane safe and effective for treating DED

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A study that assessed the safety and efficacy of perfluorohexyloctane ophthalmic (PFHO) (Miebo, Bausch + Lomb) solution showed that after 1 year of use, the formulation was safe, well tolerated, and maintained efficacy for treating the signs and symptoms of dry eye disease (DED),¹ according to first author Eugene Protzko, MD. He is from Seidenberg Protzko Eye Associates, Havre de Grace, MD.

Protzko and colleagues explained that most patients present in pactice with evaporative DED, which is primarily caused by meibomian gland dysfunction (MGD), and many patients have a mixed subtype that includes both aqueous-deficient and evaporative components.²

Numerous treatments for dry eye are available that range from warm compresses, tears, and in-office therapies to prescription medications. The approved ophthalmic formulations include cyclosporine, lifitegrast (Xiidra, Bausch + Lomb), loteprednol etabonate 0.25% (Eysuvis, Alcon),^3-5 and varenicline solution (Tyrvaya Nasal Spray, Oyster Point Pharma).^6,7

However, the investigators said, the prescription medications do not address evaporation.⁸

PFHO recently received FDA approval to treat the signs and symptoms of DED.⁹ Protkzo and colleagues wanted to evaluate the long-term safety and efficacy of PFHO in a subset of patients who continued to use PFHO or were switched from hypotonic saline to PFHO after completing the phase 3 GOBI study.

The Kalahari extension study

This was a phase 3, multicenter, single-arm, open-label, extension study of patients with DED associated with meibomian gland dysfunction, all of whom completed the randomized, double-masked, hypotonic saline-controlled GOBI study.

The patients were instructed to instill 1 drop of PFHO 4 times daily in both eyes for 1 year. The drug was assessed for adverse events, best-corrected visual acuity, slit-lamp biomicroscopy, intraocular pressure, and dilated funduscopy. The efficacy assessment included the changes from the baseline data in the GOBI study in total corneal fluorescein staining and eye dryness score (0–100 visual analog scale), the investigators explained.

The Kalahari study included 97 patients treated with PFHO and 111 treated with saline from the GOBI study.

The investigators reported that 29 patients (13.9%) had 1 or more ocular adverse event. The most common ocular adverse events were vitreous detachment (1.9%), allergic conjunctivitis (1.4%), blurred vision (1.4%), and increased lacrimation (1.4%). “For patients continuing PFHO from the GOBI study, improvements in total corneal fluorescein staining and visual analog scale dryness scores observed in GOBI were maintained throughout the Kalahari study. Patients treated with saline in the GOBI study and switched to PFHO in the Kalahari study showed improvements in total corneal fluorescein staining and visual analog scale scores by week 4 that were maintained for the rest of the study,” they reported.

They concluded that PFHO was safe and well tolerated and maintained efficacy for improving signs and symptoms of DED associated with meibomian gland dysfunction.

References

1. Protzko EE, Segal BA, Kornefeld MS, et al. Long-term safety and efficacy of perfluorohexyloctane ophthalmic solution for the treatment of patients with dry eye disease: The KALAHARI Study. Cornea. 2024;43:1100-1107; DOI: 10.1097/ICO.0000000000003418

2. Lemp MA, Crews LA, Bron AJ, et al. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012;31:472–478.

3. Holland EJ, Darvish M, Nichols KK, et al. Efficacy of topical ophthalmic drugs in the treatment of dry eye disease: a systematic literature review. Ocul Surf. 2019;17:412–423.

4. Eysuvis (Loteprednol Etabonate Ophthalmic Suspension) 0.25%, for Topical Ophthalmic Use [package insert]. Watertown, MA: Kala Pharmaceuticals, Inc; 2020.

5. Xiidra (Lifitegrast Ophthalmic Solution), for Topical Ophthalmic Use [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2020.

6. Tyrvaya (Varenicline Solution) Nasal Spray [package insert]. Princeton, NJ: Oyster Point Pharma, Inc.; 2021.

7. Wirta D, Vollmer P, Paauw J, et al. Efficacy and safety of OC-01 (varenicline solution) nasal spray on signs and symptoms of dry eye disease: the ONSET-2 phase 3 randomized trial. Ophthalmology. 2022;129:379–387.

8. Sheppard JD, Nichols KK. Dry eye disease associated with meibomian gland dysfunction: focus on tear film characteristics and the therapeutic landscape. Ophthalmol Ther. 2023;12:1397–1418.

9. MIEBO (Perfluorohexyloctane Ophthalmic Solution), for Topical Ophthalmic Use [package insert]. Bridgewater, NJ: Bausch + Lomb Americas Inc; 2023.