Fixed-dose combination of tafluprost and timolol in the treatment of open-angle glaucoma and ocular hypertension: comparison with other fixed-combination products

Abstract

A new preservative-free fixed-dose combination of 0.0015% tafluprost, a prostaglandin F2α analog, and 0.5% timolol (TAF/TIM; Santen Oy, Tampere, Finland), a beta-adrenergic antagonist has recently been developed. The intraocular pressure (IOP) reduction with TAF/TIM in open-angle glaucoma and ocular hypertension is similar to that of other prostaglandin-timolol fixed-combination products. Patients with high IOP responded well to TAF/TIM with reductions of up to 40% (>13 mmHg) and beyond. Compared to previous controlled and double-masked clinical trials with DuoTrav(®) (Alcon, Fort Worth, USA) and Ganfort(®) (Allergan, Irvine, USA), TAF/TIM caused less superficial ocular side effects and less conjunctival hyperemia. Plausible explanations for the differences in side effects between the fixed-combination products are discussed.

Fig. 1

A scatter plot of the baseline mean IOP versus reduction in mean IOP at 3 months based on the results of double-masked, randomized studies of the fixed-combination products. Results are shown from studies in which washout period from prior glaucoma medication was applied to have corresponding untreated baseline IOP values and the mean reduction at 3 months was available. Regression equation: reduction in IOP = 5.306–0.545 × (Baseline IOP). Slope P value <0.0001, adjusted R ² 0.957. IOP intraocular pressure, TAF/TIM fixed-dose combination of 0.0015% tafluprost and 0.5% timolol

Fig. 2

A scatter plot of the mean baseline IOP versus reduction in mean IOP based on the results of double-masked, randomized studies of the fixed-combination products. Results are shown from studies in which washout period from prior glaucoma medication was applied to have corresponding untreated baseline IOP. In addition to studies in Fig. 1, studies with results from endpoints other than 3 months are also included. Regression equation: reduction in IOP = 5.559−0.557 × (Baseline IOP). Slope P value <0.0001, adjusted R ² 0.874. IOP intraocular pressure, TAF/TIM fixed-dose combination of 0.0015% tafluprost and 0.5% timolol

Fig. 3

IOP reduction at 3 months in patients treated with TAF/TIM (ITT dataset). The graph is based on a combined analysis of two phase III clinical trials (Holló et al. [30] and Pfeiffer et al. [20]) for which the patient population was stratified by daytime baseline IOP (mean of 3 or 4 measurements, n for each category in parenthesis for every bar). It is evident that there is a direct relationship between the baseline IOP and the IOP reduction. In patients with mean baseline IOP of at least 31 mmHg the mean reductions in IOP of 40% (>13 mmHg) were achieved with TAF/TIM. A regression line from Fig. 1 was included to further depict that TAF/TIM is competitive in reducing IOP with regard to all other fixed prostaglandin–timolol combination products. IOP intraocular pressure, ITT intention-to-treat, TAF/TIM fixed-dose combination of 0.0015% tafluprost and 0.5% timolol