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.
