Efficacy and safety of tafluprost-timolol fixed-dose combination in open-angle glaucoma and ocular hypertension

Abstract

Purpose

To evaluate the efficacy and safety of tafluprost and timolol combination in open-angle glaucoma (OAG) and ocular hypertension (OHT).

Methods

PubMed, Embase, Scopus, ClinicalTrials.gov and Cochrane Library databases were searched from their inception until March 28, 2025. Meta-analysis was conducted utilizing the ‘metaprop’ and ‘metamean’ packages in R Studio (version 4.4.3). We pooled proportion or incidence rate along with the respective 95% confidence interval (CI) and mean difference with 95% CI for continuous outcomes using a random effects model. The I2 test was employed to assess heterogeneity between the studies.

Results

This meta-analysis included 15 studies involving 2066 patients. The pooled overall mean decrease in intraocular pressure (IOP) was −4.28 mmHg (95% CI: −6.21 to −2.34, I² = 98.1%). Subgroup analysis indicated a more substantial IOP reduction in treatment-naïve individuals of −7.81 mmHg (95% CI: −10.73 to −4.90, I² = 91.3%) when compared to the monotherapy switch group (−2.95 mmHg [95% CI: −5.09 to −0.81, I² = 98.2%]). The incidence of any adverse event was 16% (95% CI: 6% to 37%, I² = 96.2%), while incidence of serious adverse events was 2% (95% CI: 1% to 6%, I² = 54.6%) and discontinuations were at 2% (95% CI: 1% to 5%, I² = 52%).

Conclusion

The fixed-dose combination of tafluprost and timolol notably decreases IOP, particularly in treatment-naïve patients, while exhibiting minimal systemic side effects and a satisfactory safety profile, thus endorsing its clinical application in the management of glaucoma and ocular hypertension.