Purpose:
Data are presented from ophthalmology clinics in Spain participating in the VISIONARY study, examining the effectiveness, tolerability, and safety of the preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in the treatment of OAG and OHT.
Methods:
An observational, multicenter prospective study examined treatment outcomes following a switch to PF tafluprost/timolol FC in adult OAG/OHT patients demonstrating insufficient response to beta-blocker or prostaglandin analog (PGA) monotherapy. Primary end point was mean change in intraocular pressure (IOP) from baseline at month 6. Changes in the severity of ocular signs and symptoms were also assessed.
Results:
Overall, 92 patients (51.1% female) were included. Mean (standard deviation) age was 68.3 (12.1) years. Mean IOP was reduced from 21.9 mmHg at baseline to 16.7 mmHg at month 6 (22.3% decrease;
P
< 0.0001). Significant IOP reductions were observed at weeks 4 and 12 (
P
< 0.0001). Baseline PGA and beta-blocker users demonstrated mean month 6 IOP reductions of 5.5 mmHg (23.5%;
P
< 0.001) and 3.5 mmHg (14.6%;
P
= 0.029), respectively. Severity of conjunctival hyperemia, dry eye, irritation, itching, foreign body sensation, and eye pain was significantly reduced. Three treatment-related adverse events were reported, all were nonserious and mild/moderate in severity.
Conclusion:
In real-world clinical practice, PF tafluprost/timolol FC treatment provided significant IOP reductions over 6 months and was well tolerated among OAG/OHT patients showing poor response to PGA or beta-blocker monotherapy. IOP-lowering efficacy and improvements in ocular signs and symptoms were evident from week 4 and maintained over the 6-month study period. Trial Registration: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number EUPAS22204.
PurposeThe VISIONARY study assessed the efficacy of the preservative‐free tafluprost/timolol fixed‐dose combination (PF tafluprost/timolol FC) in patients with open‐angle glaucoma (OAG) or ocular hypertension (OHT) who were inadequately controlled with prostaglandin analogue (PGA) or beta‐blocker (BB) monotherapy. This analysis examined IOP reduction by diagnosis and prior treatment type.MethodsIOP was recorded at baseline for adults (≥18 years) receiving topical PGA or BB monotherapy for OAG/OHT and treatment was switched to PF tafluprost/timolol FC. IOP was recorded at Weeks 4, 12 and 24. The primary endpoint was mean absolute change in IOP from baseline at Month 6. Baseline diagnoses were OHT (n = 110), primary open‐angle glaucoma (POAG; n = 425), normal tension glaucoma (NTG; n = 13), or pseudoexfoliative glaucoma (PEX; n = 19).ResultsMean (SD) baseline IOP was 21.5 (5.00) mmHg, 22.3 (4.30) mmHg, 17.2 (2.68) mmHg and 21.7 (4.13) mmHg for patients with POAG, OHT, NTG and PEX, respectively. Respective Month 6 relative IOP reductions were 25.4%, 26.1%, 15.8% and 17.6%. Mean (SD) baseline IOP was 21.9 (4.36) mmHg and 21.4 (4.48) mmHg for BB and PGA users, respectively. Month 6 respective IOP reduction from baseline was 6.6 (4.16) mmHg (28.5%) and 5.4 (4.04) mmHg (23.6%) (p < 0.0001). PF tafluprost/timolol FC was generally well tolerated; 14 patients discontinued due to poor local tolerance or insufficient IOP control.ConclusionsIn this real‐world study, PF tafluprost/timolol FC was effective and well‐tolerated in patients previously uncontrolled on BB or PGA monotherapy, irrespective of initial diagnosis and type of previous topical medication. Patients with OHT, POAG, NTG and PEX showed IOP reductions at Week 4 that were maintained throughout the study period.BibliographyOddone F, et al. Treatment of Open‐Angle Glaucoma and Ocular Hypertension with Preservative‐Free Tafluprost/Timolol Fixed‐Dose Combination Therapy: The VISIONARY Study. Adv Ther.2020;37(4):1436–51.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.