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

References

• Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121(11):2081–2090. doi:10.1016/j.ophtha.2014.05.013
   PubMed Web of Science ®Google Scholar
• European Glaucoma Society. Terminology and guidelines for glaucoma 5th edition; 2020. Available from: https://www.eugs.org/eng/egs_guidelines_download.asp. Accessed January 20, 2022.
   Google Scholar
• Collaborative Normal-Tension Glaucoma Study Group. The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998;126:498–505. doi:10.1016/S0002-9394(98)00272-4
   PubMed Web of Science ®Google Scholar
• The AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. The AGIS investigators. Am J Ophthalmol. 2000;130:429–440. doi:10.1016/S0002-9394(00)00538-9
   PubMed Web of Science ®Google Scholar
• Heijl A, Leske MC, Bengtsson B, et al. Reduction of intraocular pressure and glaucoma progression: results from the early manifest glaucoma trial. Arch Ophthal. 2002;120:1268–1279. doi:10.1001/archopht.120.10.1268
   PubMed Web of Science ®Google Scholar
• Rulli E, Quaranta L, Riva I, et al. Visual field loss and vision-related quality of life in the Italian Primary Open Angle Glaucoma Study. Sci Rep. 2018;8(1):619. doi:10.1038/s41598-017-19113-z
   PubMed Web of Science ®Google Scholar
• Janz NK, Wren PA, Lichter PR, et al. The Collaborative Initial Glaucoma Treatment Study: interim quality of life findings after initial medical or surgical treatment of glaucoma. Ophthalmology. 2001;108:1954–1965. doi:10.1016/S0161-6420(01)00874-0
   PubMed Web of Science ®Google Scholar
• Holló G, Katsanos A, Boboridis KG, Irkec M, Konstas AG. Preservative-free prostaglandin analogs and prostaglandin/timolol fixed combinations in the treatment of glaucoma: efficacy, safety and potential advantages. Drugs. 2018;78(1):39–64. doi:10.1007/s40265-017-0843-9
   PubMed Web of Science ®Google Scholar
• Tabet R, Stewart WC, Feldman R, Konstas AG. A review of additivity to prostaglandin analogs: fixed and unfixed combinations. Surv Ophthalmol. 2008;53(1):S85–92. doi:10.1016/j.survophthal.2008.08.011
   PubMed Web of Science ®Google Scholar
• Holló G, Topouzis F, Fechtner RD. Fixed-combination intraocular pressure lowering therapy for glaucoma and ocular hypertension: advantages in clinical practice. Expert Opin Pharmacother. 2014;15(12):1737–1747. doi:10.1517/14656566.2014.936850
   PubMed Web of Science ®Google Scholar
• Konstas AG, Katsanos A, Athanasopoulos GP, et al. Preservative-free tafluprost/timolol fixed combination: comparative 24-h efficacy administered morning or evening in open-angle glaucoma patients. Expert Opin Pharmacother. 2018;19:1981–1988. doi:10.1080/14656566.2018.1534958
   PubMed Web of Science ®Google Scholar
• Figus M, Agnifili L, Lanzini M, et al. Topical preservative-free ophthalmic treatments: an unmet clinical need. Expert Opin Drug Deliv. 2020;18:655–672.
   PubMed Web of Science ®Google Scholar
• Konstas AGP, Haidich AB, Rossetti L, et al. Prostaglandin-timolol fixed combinations efficacy: myth or reality? Editorial Eur J Ophthalmol. 2012;22:1–4. doi:10.5301/ejo.5000077
   PubMed Web of Science ®Google Scholar
• Aptel F, Cucherat M, Denis P. Efficacy and tolerability of prostaglandin-timolol fixed combinations: a meta-analysis of randomized clinical trials. Eur J Ophthalmol. 2012;22:5–18. doi:10.5301/ejo.5000009
   PubMed Web of Science ®Google Scholar
• Quaranta L, Biagioli E, Riva I, et al. Prostaglandin analogs and timolol-fixed versus unfixed combinations or monotherapy for open-angle glaucoma: a systematic review and meta-analysis. J Ocul Pharmacol Ther. 2013;29:382–389. doi:10.1089/jop.2012.0186
   PubMed Web of Science ®Google Scholar
• Zhang X, Vadoothker S, Munir WM, Saeedi O. Ocular surface disease and glaucoma medications: a clinical approach. Eye Contact Lens. 2019;45(1):11–18. doi:10.1097/ICL.0000000000000544
   PubMed Web of Science ®Google Scholar
• Ferreras A, Figus M, Fogagnolo P, Iester M, Frezzotti P. Managing side effects on ocular surface caused by glaucoma eye drops. Curr Med Chem. 2019;26(22):4223–4224. doi:10.2174/092986732622190920092210
   PubMed Web of Science ®Google Scholar
• Dubrulle P, Labbé A, Brasnu E, et al. Influence of treating ocular surface disease on intraocular pressure in glaucoma patients intolerant to their topical treatments: a report of 10 cases. J Glaucoma. 2018;27(12):1105–1111. doi:10.1097/IJG.0000000000001041
   PubMed Web of Science ®Google Scholar
• Di Staso S, Agnifili L, Cecannecchia S, DI Gregorio A, Ciancaglini M. In vivo analysis of prostaglandins-induced ocular surface and periocular adnexa modifications in patients with glaucoma. In Vivo. 2018;32(2):211–220. doi:10.21873/invivo.11227
   PubMed Web of Science ®Google Scholar
• Batra R, Tailor R, Mohamed S. Ocular surface disease exacerbated glaucoma: optimizing the ocular surface improves intraocular pressure control. J Glaucoma. 2014;23(1):56–60. doi:10.1097/IJG.0b013e318264cd68
   PubMed Web of Science ®Google Scholar
• Jaenen N, Baudouin C, Pouliquen P, Manni G, Figueiredo A, Zeyen T. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eur J Ophthalmol. 2007;17(3):341–349. doi:10.1177/112067210701700311
   PubMed Web of Science ®Google Scholar
• Baudouin C. Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma. Acta Ophthalmol. 2008;86(7):716–726. doi:10.1111/j.1755-3768.2008.01250.x
   PubMed Web of Science ®Google Scholar
• Pisella PJ, Pouliquen P, Baudouin C. Prevalence of ocular symptoms and signs with preserved and preservative free glaucoma medication. Br J Ophthalmol. 2002;86(4):418–423. doi:10.1136/bjo.86.4.418
   PubMed Web of Science ®Google Scholar
• Asiedu K, Abu SL. The impact of topical intraocular pressure lowering medications on the ocular surface of glaucoma patients: a review. J Curr Ophthalmol. 2018;31(1):8–15. doi:10.1016/j.joco.2018.07.003
   PubMed Web of Science ®Google Scholar
• Aguayo Bonniard A, Yeung JY, Chan CC, Birt CM. Ocular surface toxicity from glaucoma topical medications and associated preservatives such as benzalkonium chloride (BAK). Expert Opin Drug Metab Toxicol. 2016;12(11):1279–1289. doi:10.1080/17425255.2016.1209481
   PubMed Web of Science ®Google Scholar
• Leung EW, Medeiros FA, Weinreb RN. Prevalence of ocular surface disease in glaucoma patients. J Glaucoma. 2008;17:350–355. doi:10.1097/IJG.0b013e31815c5f4f
   PubMed Web of Science ®Google Scholar
• Erb C, Gast U, Schremmer D. German register for glaucoma patients with dry eye. I. Basic outcome with respect to dry eye. Graefes Arch Clin Exp Ophthalmol. 2008;246:1593–1601. doi:10.1007/s00417-008-0881-9
   PubMed Web of Science ®Google Scholar
• Garcia-Feijoo J, Sampaolesi JR. A multicentre evaluation of ocular surface disease prevalence in patients with glaucoma. Clin Ophthalmol. 2012;6:441–446. doi:10.2147/OPTH.S29158
   PubMedGoogle Scholar
• Boimer C, Birt CM. Preservative exposure and surgical outcomes in glaucoma patients: the PESO study. J Glaucoma. 2013;22:730–735. doi:10.1097/IJG.0b013e31825af67d
   PubMed Web of Science ®Google Scholar
• Pfeiffer N, Traverso CE, Lorenz K, et al. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther. 2014;31:1228–1246. doi:10.1007/s12325-014-0163-3
   PubMed Web of Science ®Google Scholar
• Holló G, Hommer A, Antón López A, et al. Efficacy, safety, and tolerability of preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% versus concomitant use of the ingredients. J Ocul Pharmacol Ther. 2014;30:468–475. doi:10.1089/jop.2013.0229
   PubMed Web of Science ®Google Scholar
• Holló G, Katsanos A. Safety and tolerability of the tafluprost/timolol fixed combination for the treatment of glaucoma. Expert Opin Drug Saf. 2015;14:609–617. doi:10.1517/14740338.2015.1010507
   PubMed Web of Science ®Google Scholar
• Kaarniranta K, Ikaheimo K, Mannermaa E, et al. Pharmacokinetics, efficacy, and safety of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% in healthy volunteers: a Phase I comparison vs. the corresponding preservative-free monotherapies. Clin Pharmacokinet. 2016;55:485–494. doi:10.1007/s40262-015-0331-x
   PubMed Web of Science ®Google Scholar
• Hoy SM. Tafluprost/timolol: a review in open-angle glaucoma or ocular hypertension. Drugs. 2015;75:1807–1813. doi:10.1007/s40265-015-0476-9
   PubMed Web of Science ®Google Scholar
• Oddone F, Tanga L, Kóthy P, Holló G; VISIONARY Study Group. 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):1436–1451. doi:10.1007/s12325-020-01239-8
   PubMed Web of Science ®Google Scholar
• Pillunat LE, Erb C, Ropo A, Kimmich F, Pfeiffer N. Preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma and ocular hypertension: results of an open-label observational study. Clin Ophthalmol. 2017;11:1051–1064. doi:10.2147/OPTH.S128453
   PubMed Web of Science ®Google Scholar
• Bourne RRA, Kaarniranta K, Lorenz K, et al. Changes in ocular signs and symptoms in patients switching from bimatoprost–timolol to tafluprost–timolol eye drops: an open-label Phase IV study. BMJ Open. 2019;9:e024129. doi:10.1136/bmjopen-2018-024129
   PubMed Web of Science ®Google Scholar
• Spitzer E, Cannon CP, Serruys PW. Should real-world evidence be incorporated into regulatory approvals? Expert Opin Drug Saf. 2018;9:1–5.
   Google Scholar
• Eichler HG, Bloechl-Daum B, Broich K, et al. Data rich, information poor: can we use electronic health records to create a learning healthcare system for pharmaceuticals? Clin Pharmacol Ther. 2019;105(4):912–922. doi:10.1002/cpt.1226
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and food and drug administration staff; 2018. Available from: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM513027.pdf. Accessed January 20, 2022.
   Google Scholar
• Holló G, Kóthy P; A magyarországi VISIONARY-vizsgálók. The Hungarian VISIONARY Study: Hungarian results in the European multicenter preservative-free tafluprost/timolol fixed combination investigation. Ophthalmologia Hungarica. 2020;157(3):196–201. Hungarian.
   Google Scholar
• Ansari E, Pavicic-Astalos J, Ayan F, et al. 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. Adv Ther. 2021;38(6):2990–3002. doi:10.1007/s12325-021-01725-7
   PubMed Web of Science ®Google Scholar
• Karlova EV, Petrov SY, Germanova VN. Preservative-free fixed combination in the treatment of open-angle glaucoma and ocular hypertension: the VISIONARY Study (EUPAS22204). Vestn Oftalmol. 2020;136(4):76–84. Russian. doi:10.17116/oftalma202013604176
   PubMedGoogle Scholar
• Garcia-Medina JJ, Benitez-del-Castillo J, Rodríguez-Agirretxe I, Lopez-Lopez F, Moreno-Valladares A; The VISIONARY study group (Spain). Treatment of open-angle glaucoma and ocular hypertension with preservative-free tafluprost/timolol fixed-dose combination therapy: results from the VISIONARY study population in Spain. J Ocul Pharmacol Ther. 2022;38:252–260. doi:10.1089/jop.2021.0099
   PubMed Web of Science ®Google Scholar
• Holló G, Vuorinen J, Tuominen J, Huttunen T, Ropo A, Pfeiffer N. Fixed-dose combination of tafluprost and timolol in the treatment of open-angle glaucoma and ocular hypertension: comparison with other fixed-combination products. Adv Ther. 2014;31(9):932–944. doi:10.1007/s12325-014-0151-7
   PubMed Web of Science ®Google Scholar
• NIDEK Co. LTD. Conversion table for representation of visual acuity. Available from: https://www.nidek-intl.com/visual_acuity.html. Accessed January 20, 2022.
   Google Scholar
• Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003;22(7):640–650. doi:10.1097/00003226-200310000-00008
   PubMed Web of Science ®Google Scholar
• Bhapkar V. A note on the equivalence of two test criteria for hypotheses in categorical data. J Am Stat Assoc. 1966;61(313):228–235. doi:10.1080/01621459.1966.10502021
   Web of Science ®Google Scholar
• Pacwa A, Machowicz J, Wojtyniak A, et al. SCD1-fatty acid desaturase inhibitor MF-438 alleviates latent inflammation induced by preservative-free prostaglandin analog eye drops. J Inflamm Res. 2022;15:793–806. doi:10.2147/JIR.S347784
   PubMed Web of Science ®Google Scholar
• Trzeciecka A, Paterno JJ, Toropainen E, et al. Long-term topical application of preservative-free prostaglandin analogues evokes macrophage infiltration in the ocular adnexa. Eur J Pharmacol. 2016;788:12–20. doi:10.1016/j.ejphar.2016.06.014
   PubMed Web of Science ®Google Scholar