Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study

Abstract

Introduction: A non-interventional, multicenter, European, prospective evaluation of the effectiveness, tolerability, and safety of a topical preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) demonstrating insufficient response to topical beta-receptor blockers or prostaglandin analogue (PGA) monotherapy. Methods: Mean intraocular pressure (IOP) change from baseline was measured at study visits following a switch to PF tafluprost/timolol FC. Primary endpoint was absolute mean IOP change at month 6. Change from baseline concerning ocular signs and symptoms was also explored.Results: Analyses included 577 patients (59.6% female). Mean age (SD) was 67.8 (11.67) years. Mean (SD) IOP reduction from baseline was significant at all study visits; 5.4 (3.76) mmHg (23.7%) at week 4, 5.9 (3.90) mmHg (25.6%) at week 12, and 5.7 (4.11) mmHg (24.9%) at month 6 (p \ 0.0001 for all visits). At month 6, 69.2%, 53.6%, 40.0%, and 25.8% were responders based on C 20%, C 25%, C 30%, and C 35% cutoff values for mean IOP, respectively. Significant reductions were observed concerning corneal fluorescein staining (p \ 0.0001), dry eye symptoms, irritation, itching, and foreign body sensation (p \ 0.001 for each parameter). Conjunctival hyperemia was significantly reduced at all study visits (p \ 0.0001 at each visit). Overall, 69 treatment-related adverse events (AEs) were reported, one of which was serious (status asthmaticus). Most AEs were mild to moderate in severity, and the majority had resolved or were resolving at the end of the study period. Conclusion: In clinical practice, PF tafluprost/timolol FC provided statistically and clinically significant IOP reductions in patients with OAG and OHT insufficiently controlled on or intolerant to PGA or beta-receptor blocker monotherapy. The full IOP reduction appeared at week 4 and was maintained over the 6-month study period. Key symptoms of ocular surface health improved. Trial Registration: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.The members of The VISIONARY Study Group are listed in Acknowledgements. Key Summary PointsWhy carry out this study?Prostaglandin analogue (PGA) and betareceptor blocker combination therapies are among the most extensively used intraocular pressure (IOP)-lowering treatments in glaucoma care. Fixed-dose combinations simplify the treatment regimen and reduce the number of daily instillations, compared with administration of the corresponding concomitant medications, and preservative-free formulations are generally considered to offer improved tolerability.The VISIONARY study aimed to provide real-world data concerning the treatment effectiveness of the preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in people with open-angle glaucoma (OAG) and ocular hypertension (OHT) who demonstrated an insufficient response ...

Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: UK and Ireland Results from the VISIONARY Study

“…The inclusion and exclusion criteria are summarised in Supplementary Table S1. Details of the trial design are published elsewhere [ 12 ]. In brief, male or female patients aged at least 18 years with a diagnosis of OAG or OHT were recruited.…”

“…1 ). Eleven countries were included in the study; however, this paper presents results from the UK and Ireland only [ 12 ]. Data were recorded during routine clinical visits and were entered into electronic case report forms.…”

“…The VISIONARY study evaluated the effectiveness and tolerability of PF Taf-T FC treatment in patients with OAG or ocular hypertension (OHT) over 6 months who previously had an insufficient response to either PGA or beta blocker monotherapy, or who did not tolerate these medications, and were judged by their physician to benefit from preservative-free eye drops. Results from the full data set have previously been published [ 12 ]. This paper presents the data and further country-specific analysis for patients in the UK and Ireland, and discusses the potential differences between these countries and the full data set.…”

Dorzolamide/Timolol Fixed Combination: Learning from the Past and Looking Toward the Future

“…Cumulative evidence indicates that long-term IOP-lowering therapies elicit chronic, low-grade ocular surface inflammation which constitutes an important risk factor for a higher rate of adverse events, reduced tolerability, unsuccessful therapy, enhanced scarring, and subsequent failure of filtration surgery [ 16 , 46 , 47 ]. PF FCs eliminate the toxic effect of preservatives, confer a long-term benefit for patients on lifelong IOP-lowering medical therapy, and may represent the future of lifelong medical therapy [ 46 , 48 – 50 ]. There is, however, still insufficient controlled evidence demonstrating the precise impact of PF medications upon the long-term success of glaucoma therapy [ 16 , 40 ].…”

A Topical Preservative-free Fixed-dose Combination Remedy in Patients with Glaucoma with Insufficient Response to Monotherapy – The VISIONARY Study

“…This was a multicentre, European prospective study that evaluated the effectiveness, tolerability and safety of TAF/TIM FC in routine clinical practice in adults with open-angle glaucoma (OAG) and ocular hypertension who demonstrated an insufficient response to previous monotherapy treatment with topical beta blockers or prostaglandin analogues. 6 In an expert interview, Dr Oddone discusses the findings of the VISIONARY study.…”