Hollo Gábor
Tutkimusz Ltd., Solymár, Hungary.
Eye Center, Prima Medica Health Centers, Budapest, Hungary.
Clin Ophthalmol. 2024 Nov 8;18:3185-3196. doi: 10.2147/OPTH.S479852. eCollection 2024.
The preservative-free fixed-dose combination formulation of 0.0015% tafluprost and 0.5% timolol (PF tafluprost/timolol FC) is among the topical intraocular pressure (IOP)-lowering therapies commonly used second-line for the management of ocular hypertension (OHT) and open-angle glaucoma (OAG), according to recommended treatment pathways. A growing body of evidence has developed in recent years regarding efficacy, safety and tolerability outcomes with PF tafluprost/timolol FC in both randomized controlled trials (RCTs) and real-life studies. This review aims to summarize key evidence from published Phase IV trials and real-life studies to highlight those data that complement RCT findings and support implementation of evidence-informed clinical practice. Real-life efficacy and safety outcomes are discussed through the lens of common clinical scenarios that ophthalmologists may encounter in the management of OHT/OAG. Phase IV studies conducted to date have demonstrated that the majority of OHT/OAG patients insufficiently controlled on topical prostaglandin or beta-blocker monotherapy may achieve IOP reductions of ≥20% following a switch to PF tafluprost/timolol FC therapy. Statistically significant IOP reductions were reported from 4 weeks and maintained through 6 months. Real-life studies and case series data also indicated that patients with poor IOP control on maximal/complex topical regimens benefited from a step down to PF tafluprost/timolol FC therapy, achieving significant and sustained IOP reductions. A number of studies have shown improvements in tolerability and the signs and symptoms of ocular health with PF tafluprost/timolol FC therapy, both in patients stepping up from monotherapy and in those simplifying their topical regimen. Clinicians reported better treatment adherence with PF tafluprost/timolol FC compared with prior treatments, which may have been associated with enhanced patient experience regarding treatment tolerability and is likely to have contributed to the long-term IOP-lowering efficacy outcomes observed. Real-life safety data for PF tafluprost/timolol FC reflect outcomes reported in published RCTs.
根据推荐的治疗路径，0.0015%他氟前列素和0.5%噻吗洛尔的无防腐剂固定剂量复方制剂（PF他氟前列素/噻吗洛尔FC）是常用于治疗高眼压症（OHT）和开角型青光眼（OAG）的二线局部降眼压疗法之一。近年来，在随机对照试验（RCT）和真实世界研究中，关于PF他氟前列素/噻吗洛尔FC的疗效、安全性和耐受性结果的证据越来越多。本综述旨在总结已发表的IV期试验和真实世界研究的关键证据，以突出那些补充RCT结果并支持循证临床实践实施的数据。通过眼科医生在OHT/OAG管理中可能遇到的常见临床场景来讨论真实世界的疗效和安全性结果。迄今为止进行的IV期研究表明，大多数局部前列腺素或β受体阻滞剂单药治疗控制不佳的OHT/OAG患者，在改用PF他氟前列素/噻吗洛尔FC治疗后，眼压可降低≥20%。从第4周开始报告有统计学意义的眼压降低，并持续6个月。真实世界研究和病例系列数据还表明，在最大剂量/复杂局部治疗方案下眼压控制不佳的患者，从降级至PF他氟前列素/噻吗洛尔FC治疗中获益，眼压显著且持续降低。多项研究表明，PF他氟前列素/噻吗洛尔FC治疗在从单药治疗升级的患者和简化局部治疗方案的患者中，耐受性以及眼部健康的体征和症状均有改善。临床医生报告，与先前治疗相比，PF他氟前列素/噻吗洛尔FC的治疗依从性更好，这可能与患者在治疗耐受性方面的体验增强有关，并且可能有助于观察到长期的降眼压疗效结果。PF他氟前列素/噻吗洛尔FC的真实世界安全性数据反映了已发表RCT中报告的结果。
