Treatment of Open-Angle Glaucoma and Ocular Hypertension with the Fixed-Dose Combination of Preservative-Free Tafluprost/Timolol: Clinical Outcomes from Ophthalmology Clinics in Italy

Francesco Oddone; Vincenzo Scorcia; Michele Iester; Dario Sisto; Stefano De Cilla; Paolo Bettin; Carlo Cagini; Michele Figus; Giorgio Marchini; Luca Rossetti; Gemma Rossi; Tommaso Salgarello; Gian Luca Scuderi; Giovanni Staurenghi; VISIONARY Study Group (Italy)

doi:10.2147/OPTH.S364880

Treatment of Open-Angle Glaucoma and Ocular Hypertension with the Fixed-Dose Combination of Preservative-Free Tafluprost/Timolol: Clinical Outcomes from Ophthalmology Clinics in Italy

Clin Ophthalmol. 2022 Jun 1:16:1707-1719. doi: 10.2147/OPTH.S364880. eCollection 2022.

Authors

Affiliations

¹ Glaucoma Unit, IRCSS-Fondazione Bietti, Roma, Italy.
² Department of Ophthalmology, University Magna Græcia of Catanzaro, Catanzaro, Italy.
³ Eye Clinic of Genoa, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genova, Genova, Italy.
⁴ Ophthalmology Department, University of Bari, Bari, Italy.
⁵ Department of Health Sciences, Eye Clinic, University of Piemonte Orientale, Novara, Italy.
⁶ Department of Ophthalmology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milano, Italy.
⁷ Department of Medicine and Surgery, Ophthalmology Section, University of Perugia, Perugia, Italy.
⁸ Ophthalmology, Department of Surgery, Medicine, Molecular and Emergency, University of Pisa, Pisa, Italy.
⁹ Ophthalmology Unit, Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy.
¹⁰ Eye Clinic, San Paolo Hospital, University of Milan, Milano, Italy.
¹¹ University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
¹² Ophthalmology Unit, Department of Ageing, Neurosciences, Head-Neck and Orthopaedics Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.
¹³ Institute of Ophthalmology, Università Cattolica del Sacro Cuore, Roma, Italy.
¹⁴ NESMOS Department, Ophthalmology Unit, St. Andrea Hospital, Università di Roma La Sapienza, Roma, Italy.
¹⁵ Eye Clinic, Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Milano, Italy.

Abstract

Introduction: The VISIONARY study examined the intraocular pressure (IOP)-lowering efficacy and tolerability of the preservative-free fixed-dose combination of tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in a real-world setting. The country-level data reported herein comprise the largest and first observational study of PF tafluprost/timolol FC therapy in Italy.

Methods: An observational, multicenter, prospective study included adult Italian patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) demonstrating insufficient response or poor tolerability with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Treatment was switched to PF tafluprost/timolol FC therapy at baseline. Primary endpoint was the absolute mean IOP change from baseline at Month 6. Exploratory and safety endpoints included change in IOP at Weeks 4 and 12, ocular signs, symptom severity and reporting of adverse events (AEs).

Results: Overall, 160 OAG/OHT patients were included. Mean ± standard deviation IOP was reduced from 19.6 ± 3.6 mmHg at baseline to 14.5 ± 2.6 mmHg at Month 6 (reduction of 5.1 ± 3.7 mmHg; 24.1%; p < 0.0001). IOP reduction was also statistically significant at Week 4 (23.1%; p < 0.0001) and Week 12 (24.7%; p < 0.0001). Based on data cutoff values for mean IOP change of ≥20%, ≥25%, ≥30% and ≥35%, respective Month 6 responder rates were 68.1%, 48.7%, 36.2% and 26.9%. Most ocular signs and symptoms were significantly reduced in severity from baseline at Month 6. Two non-serious and mild AEs were reported during the study period, among which, one AE was treatment-related (eyelash growth). .

Conclusion: Italian OAG and OHT patients demonstrated a significant IOP reduction from baseline at Week 4 that was maintained over a 6-month period following a switch from topical PGA or beta-blocker monotherapy to PF tafluprost/timolol FC therapy. Severity of most ocular signs and symptoms was significantly reduced during the study period, and PF tafluprost/timolol FC was generally well tolerated.

Keywords: PF tafluprost/timolol FC; fixed-dose combination therapy; intraocular pressure; ocular hypertension; preservative-free topical medication; primary open-angle glaucoma.

Grants and funding

The study was funded by Santen SA, Switzerland. Sponsorship funding for medical writing services and Article Publishing Charges was provided by Santen Italy. The contribution of the authors affiliated with the IRCCS Fondazione Bietti was supported by the Italian Ministry of Health and by Fondazione Roma.