Clinical Ophthalmology (Jun 2022)

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

  • Oddone F,
  • Scorcia V,
  • Iester M,
  • Sisto D,
  • De Cilla S,
  • Bettin P,
  • Cagini C,
  • Figus M,
  • Marchini G,
  • Rossetti L,
  • Rossi G,
  • Salgarello T,
  • Scuderi GL,
  • Staurenghi G

Journal volume & issue
Vol. Volume 16
pp. 1707 – 1719

Abstract

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Francesco Oddone,1 Vincenzo Scorcia,2 Michele Iester,3 Dario Sisto,4 Stefano De Cilla,5 Paolo Bettin,6 Carlo Cagini,7 Michele Figus,8 Giorgio Marchini,9 Luca Rossetti,10 Gemma Rossi,11 Tommaso Salgarello,12,13 Gian Luca Scuderi,14 Giovanni Staurenghi15 On behalf of the VISIONARY Study Group (Italy)1Glaucoma Unit, IRCSS-Fondazione Bietti, Roma, Italy; 2Department of Ophthalmology, University Magna Græcia of Catanzaro, Catanzaro, Italy; 3Eye Clinic of Genoa, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genova, Genova, Italy; 4Ophthalmology Department, University of Bari, Bari, Italy; 5Department of Health Sciences, Eye Clinic, University of Piemonte Orientale, Novara, Italy; 6Department of Ophthalmology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milano, Italy; 7Department of Medicine and Surgery, Ophthalmology Section, University of Perugia, Perugia, Italy; 8Ophthalmology, Department of Surgery, Medicine, Molecular and Emergency, University of Pisa, Pisa, Italy; 9Ophthalmology Unit, Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy; 10Eye Clinic, San Paolo Hospital, University of Milan, Milano, Italy; 11University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy; 12Ophthalmology Unit, Department of Ageing, Neurosciences, Head-Neck and Orthopaedics Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy; 13Institute of Ophthalmology, Università Cattolica del Sacro Cuore, Roma, Italy; 14NESMOS Department, Ophthalmology Unit, St. Andrea Hospital, Università di Roma La Sapienza, Roma, Italy; 15Eye Clinic, Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Milano, ItalyCorrespondence: Francesco Oddone, Glaucoma Unit, IRCSS-Fondazione Bietti, Roma, Italy, Tel + 39 06 85356727, Email [email protected]: 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). 𠀼onclusion: 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: fixed-dose combination therapy, intraocular pressure, ocular hypertension, PF tafluprost/timolol FC, preservative-free topical medication, primary open-angle glaucoma

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