Ballesteros-Sánchez Antonio, Llort-Vilaró Sara, Sánchez-González José-María, Borroni Davide, Rocha-de-Lossada Carlos
School of Optics and Optometry, Carrer del Violinista Vellsola, Universitat Politècnica de Catalunya, 08222, Terrassa, Spain.
Department of Physics of Condensed Matter, Optics Area, University of Seville, 41012, Seville, Spain.
Ophthalmol Ther. 2025 Oct;14(10):2571-2587. doi: 10.1007/s40123-025-01217-9. Epub 2025 Aug 26.
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).
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.
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; I = 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; I = 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; I = 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; I = 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; I = 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; I = 0%) (rate CyclASol: 2.8% [10 eyes]; rate CsA: 3.7% [8 eyes]; rate difference: -0.9%).
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.
比较0.05%和0.1%无水环孢素制剂（CyclASol）与赋形剂及0.05%环孢素（CsA）在干眼症（DED）患者中的安全性。
根据PRISMA声明，对三个数据库（截至2025年4月4日的PubMed、Scopus和Web of Science）中有关CyclASol在DED患者中的安全性进行了一项系统评价和荟萃分析。
纳入了四项随机对照试验（RCT），涉及1575例患者的1575只眼睛。荟萃分析显示，CyclASol组与对照组之间出现治疗中出现的不良事件（TEAE）的可能性无显著差异（风险比[RR]：0.98；95%置信区间[CI] 0.85 - 1.12；P = 0.72；I = 43%）（CyclASol发生率：30.3% [240只眼]；对照组发生率：30.9% [243只眼]；率差：-0.6%）。眼部TEAE也观察到类似结果（RR：1.00；95% CI 0.78 - 1.30；P = 0.97；I = 0%）（CyclASol发生率：3.6% [95只眼]；对照组发生率：3.7% [93只眼]；率差：-0.1%）。关于敏感性分析，CyclASol组与赋形剂组之间出现TEAE的可能性无显著差异（RR：1.02；95% CI 0.88 - 1.18；P =
0.83；I = 44%）（CyclASol发生率：32.5% [240只眼]；赋形剂发生率：30.3% [222只眼]；率差：2.2%）。眼部TEAE也得到了类似结果（RR：1.07；95% CI 0.81 - 1.41；P = 0.65；I = 0%）（CyclASol发生率：4.1% [95只眼]；赋形剂发生率：3.6% [85只眼]；率差：0.5%）。同样，将CyclASol与0.05% CsA比较时，TEAE也无统计学显著差异（RR：0.74；95% CI 0.51 - 1.09；P = 0.13；I = 5%）（CyclASol发生率：29.4% [30只眼]；CsA发生率：39.6% [21只眼]；率差：-10.2%）。两组之间的眼部TEAE也相当（RR：0.67；95% CI 0.32 - 1.41；P = 0.2
9；I = 0%）（CyclASol发生率：2.8% [10只眼]；CsA发生率：3.7% [8只眼]；率差：-0.9%）。
基于荟萃分析中呈现的数据，CyclASol对DED患者是一种安全的治疗方法。然而，CyclASol与0.05% CsA之间出现TEAE和眼部TEAE的可能性相当，这表明没有足够的证据表明CyclASol的安全性优于市售的CsA。
