Efficacy and safety of perfluorohexyloctane (PFHO) in patients with dry eye disease (DED) due to meibomian gland dysfunction (MGD): Systematic review and meta-analysis.

BACKGROUND

Dry eye disease (DED) associated with meibomian gland dysfunction lacks a conclusive treatment, placing existing solutions under the burden of side effects and limitations. This study seeks to assess the efficacy and safety of perfluorohexyloctane (PFHO) in treating DED associated with meibomian gland dysfunction.

METHODS

A thorough search encompassing Medline, Cochrane Central Register, and Google Scholar was conducted until September 15, 2023. Four randomized controlled trials were assessed for PFHO's safety and efficacy. Studies were managed with EndNote and Excel for dual-phase screening by reviewers. Bias risk was evaluated with the risk of bias 2.0 Cochrane tool, and comparative outcomes were synthesized using RevMan software.

RESULTS

In this meta-analysis, we pooled data from 4 randomized controlled trials involving 1754 patients. Significant reductions were observed in total corneal fluorescein staining score mean difference = -0.87 (95% CI -1.06, -0.68, P < .00001), eye dryness score mean difference = -7.73 (95% CI -9.17, -6.29, P < .00001), and central Corneal Fluorescein Staining score risk ratios (RR) = 5.11 (95% CI: 1.75-14.93, P = .003). Subgroup analysis highlighted increasing differences over time, notably at week 8. Safety analysis showed decreased risk of eye pain RR = 0.70 (95% CI: 0.27, 1.80, P = .46) and blurred vision RR = 5.11 (95% CI: 1.75, 14.93, P = .003) with PFHO. There was no significant difference noted in serious adverse events RR = 1.38 (95% CI: 0.25, 7.60, P = .71), ocular TEAS RR = 1.05 (95% CI: 0.81, 1.37, P = .69) and non-ocular TEAS RR = 1.02 (95% CI: 0.75, 1.40, P = .89).

CONCLUSION

PFHO marks a novel treatment for DED, targeting tear evaporation with its unique water-free, preservative-free preparation. It has proved to be highly effective in alleviating eye dryness and associated symptoms. While minor side effects are seen in a small subset of patients, the overall safety is promising. Further long-term and larger sample size studies will offer a more thorough understanding of this new drug.