Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study
Francesco Oddone, Lucia Tanga, Péter Kóthy, Gábor Holló, The VISIONARY Study Group, Christoph Faschinger, Enping Chen, Gábor Holló, Gábor Németh, György Bátor, Alexis Tsorbatzoglou, Tamás Ács, Mária Ferencz, Zoltán Sohajda, Jenő Tóth, Veronika Volner, Gábor Vogt, Zsolt Bíró, Andrea Facskó, J Nemes, András Berta, Ilona Elek, Eugene Ng, Francesco Oddone, Gemma Caterina Maria Rossi, Luca Rossetti, Michele Vetrugno, Michele Iester, Giorgio Marchini, Vincenzo Scorcia, Giovanni Staurenghi, Carlo Cagini, Tommaso Salgarello, Paolo Bettin, Michele Figus, Gianluca Scuderi, Stefano De Cillà, Iveta Grundmane, Nora Linavska, Lāsma Volksone, Guna Laganovska, Kristīne Baumane, Hans G. Lemij, Kjell Gunnar Gundersen, Marina Zimina, В. П. Еричев, Elena Karlova, Ekaterina Zakharova, И. Е. Панова, Boris Malyugin, Inaki Rodriguez Aguirrec, Fernando López-López, Antonio Moreno Valladares, Javier Benítez del Castillo Sánchez, Rafael Giménez, María Parrilla Vallejo, José García Medina, Alfonso Antón López, Sergio Torregrosa, Jorge Loscos, Miriam Kolko, Ejaz Ansari, David C. Broadway, Katharine Claridge, Simon Ruben, James Kirwan, Anca Niţă, Micheal Smith, Areeb Moosavi, Anthony King, Matthew Kinsella
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 ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 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.