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Introduction <p>To compare the safety of 0.05% and 0.1% water-free cyclosporine formulation (CyclASol) with vehicle and 0.05% cyclosporine (CsA) in patients with dry eye disease (DED).</p> Methods <p>A systematic review with meta-analysis, reporting on the safety of CyclASol in patients with DED in three databases (PubMed, Scopus, and Web of Science until 4 April 2025), was performed according to the PRISMA statement.</p> Results <p>Four randomized controlled trials (RCTs) were included, encompassing 1575 eyes from 1575 patients. The meta-analysis revealed no significant difference in the likelihood of experiencing treatment-emergent adverse events (TEAEs) between CyclASol and control groups (risk ratio [RR]: 0.98; 95% confidence interval [CI] 0.85–1.12; <i>P</i> = 0.72; <i>I</i><sup>2</sup> = 43%) (rate CyclASol: 30.3% [240 eyes]; rate controls: 30.9% [243 eyes]; rate difference: –0.6%). Similar results were observed for ocular TEAEs (RR: 1.00; 95% CI 0.78–1.30; <i>P</i> = 0.97; <i>I</i><sup>2</sup> = 0%) (rate CyclASol: 3.6% [95 eyes]; rate controls: 3.7% [93 eyes]; rate difference: –0.1%). Regarding sensitivity analyses, no significant difference in the likelihood of TEAEs was observed between CyclASol and vehicle groups (RR: 1.02; 95% CI 0.88–1.18; <i>P</i> = 0.83; <i>I</i><sup>2</sup> = 44%) (rate CyclASol: 32.5% [240 eyes]; rate vehicle: 30.3% [222 eyes]; rate difference: 2.2%). Comparable results were found for ocular TEAEs (RR: 1.07; 95% CI 0.81–1.41; <i>P</i> = 0.65; <i>I</i><sup>2</sup> = 0%) (rate CyclASol: 4.1% [95 eyes]; rate vehicle: 3.6% [85 eyes]; rate difference: 0.5%). Similarly, no statistically significant differences in TEAEs were observed when comparing CyclASol with 0.05% CsA (RR: 0.74; 95% CI 0.51–1.09; <i>P</i> = 0.13; <i>I</i><sup>2</sup> = 5%) (rate CyclASol: 29.4% [30 eyes]; rate CsA: 39.6% [21 eyes]; rate difference: –10.2%). Ocular TEAEs also remained comparable between groups (RR: 0.67; 95% CI 0.32–1.41; <i>P</i> = 0.29; <i>I</i><sup>2</sup> = 0%) (rate CyclASol: 2.8% [10 eyes]; rate CsA: 3.7% [8 eyes]; rate difference: –0.9%).</p> Conclusions <p>Based on the data presented in the meta-analysis, CyclASol is a safe treatment for patients with DED. However, the comparable likelihood of experiencing TEAEs and ocular TEAEs between CyclASol and 0.05% CsA suggests that there is not sufficient evidence to indicate a superior safety profile of CyclASol over commercially available CsA.</p>

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Assessment the Safety of CyclASol compared with Vehicle and Commercially Available 0.05% Cyclosporine in Dry Eye Disease: A Systematic Review and Meta-analysis

  • 期刊论文

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  • 发表日期：

    2025年8月26日

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  • Antonio Ballesteros-Sánchez,
  • Sara Llort-Vilaró,
  • José-María Sánchez-González,
  • Davide Borroni,
  • Carlos Rocha-de-Lossada

摘要

Introduction

To compare the safety of 0.05% and 0.1% water-free cyclosporine formulation (CyclASol) with vehicle and 0.05% cyclosporine (CsA) in patients with dry eye disease (DED).

Methods

A systematic review with meta-analysis, reporting on the safety of CyclASol in patients with DED in three databases (PubMed, Scopus, and Web of Science until 4 April 2025), was performed according to the PRISMA statement.

Results

Four randomized controlled trials (RCTs) were included, encompassing 1575 eyes from 1575 patients. The meta-analysis revealed no significant difference in the likelihood of experiencing treatment-emergent adverse events (TEAEs) between CyclASol and control groups (risk ratio [RR]: 0.98; 95% confidence interval [CI] 0.85–1.12; P = 0.72; I2 = 43%) (rate CyclASol: 30.3% [240 eyes]; rate controls: 30.9% [243 eyes]; rate difference: –0.6%). Similar results were observed for ocular TEAEs (RR: 1.00; 95% CI 0.78–1.30; P = 0.97; I2 = 0%) (rate CyclASol: 3.6% [95 eyes]; rate controls: 3.7% [93 eyes]; rate difference: –0.1%). Regarding sensitivity analyses, no significant difference in the likelihood of TEAEs was observed between CyclASol and vehicle groups (RR: 1.02; 95% CI 0.88–1.18; P = 0.83; I2 = 44%) (rate CyclASol: 32.5% [240 eyes]; rate vehicle: 30.3% [222 eyes]; rate difference: 2.2%). Comparable results were found for ocular TEAEs (RR: 1.07; 95% CI 0.81–1.41; P = 0.65; I2 = 0%) (rate CyclASol: 4.1% [95 eyes]; rate vehicle: 3.6% [85 eyes]; rate difference: 0.5%). Similarly, no statistically significant differences in TEAEs were observed when comparing CyclASol with 0.05% CsA (RR: 0.74; 95% CI 0.51–1.09; P = 0.13; I2 = 5%) (rate CyclASol: 29.4% [30 eyes]; rate CsA: 39.6% [21 eyes]; rate difference: –10.2%). Ocular TEAEs also remained comparable between groups (RR: 0.67; 95% CI 0.32–1.41; P = 0.29; I2 = 0%) (rate CyclASol: 2.8% [10 eyes]; rate CsA: 3.7% [8 eyes]; rate difference: –0.9%).

Conclusions

Based on the data presented in the meta-analysis, CyclASol is a safe treatment for patients with DED. However, the comparable likelihood of experiencing TEAEs and ocular TEAEs between CyclASol and 0.05% CsA suggests that there is not sufficient evidence to indicate a superior safety profile of CyclASol over commercially available CsA.