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

García-Medina, J.J.; Benítez-del-Castillo, Javier; Rodríguez-Agirretxe, Iñaki; Lopez-Lopez, Fernando; Moreno-Valladares, A.

doi:10.1089/jop.2021.0099

Cited by 6 publications

(4 citation statements)

References 55 publications

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“…This study also found that the EDV and PSV levels of the CRA and the SPCA were signi cantly increased and the RI level of the CRA and the SPCA were signi cantly decreased after treatment in both groups. In addition, the improvement of the above indexes in the observation group is more remarkable, which indicates that Ta uprost has a better effect on ocular hemodynamics in patients with primary open-angle glaucoma, which is consistent with previous studies.. VEGF drugs are widely used in the treatment of neovascular glaucoma, for example trabeculectomy combined with conbercept or ranibizumab in the treatment of neovascular glaucoma (NVG) can make new blood vessels regress, effectively control IOP and improve vision, and the e cacy of the above treatment was achieved through the regulation of VEGF [18][19]. In addition, postoperative application of brinzolamide combined with timolol eye drops in the treatment of NVG patients can effectively reduce IOP and control its uctuations, and these effects are mainly achieved by regulating the balance of angiogenesis promoting/inhibiting factors, VEGF and its receptors.…”

Section: Analysis Of Clinical Effect Of Ta Uprost On Patients With Pr...supporting

confidence: 86%

Effect of Tafluprost on Endothelial Function-related Molecules and Hemorheological Parameters in Patients with Primary Open-angle Glaucoma

Liu

Nie

et al. 2023

Preprint

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Objectives This study analyzed the effect of tafluprost on endothelial function-related molecules and hemorheological parameters in patients with primary open-angle glaucoma, and provided reference for clinical treatment.Methods Patients with primary open-angle glaucoma diagnosed and treated in our hospital from January 2018 to March 2019 were selected as the research subjects. 70 patients (140 eyes) were randomly divided into two groups: control group (n = 35 cases, 70 eyes) and observation group (n = 35 cases, 70 eyes). The patients in the control group received timolol maleate eye drops, and the patients in the observation group received tafluprost eye drops. The clinical effects of the two groups of patients were analyzed, and the changes of endothelial function-related molecule [vascular endothelial growth factor (VEGF) level] were detected before and after treatment, and the changes of blood rheology parameters before and after treatment in the two groups were analyzed.Results The total effective rate of the observation group was significantly higher than that of the control group (P < 0.05). After treatment, the visual acuity of the two groups was significantly increased while the intraocular pressure (IOP) was significantly decreased (P < 0.05), and the levels of VEGF and its receptors in serum were significantly increased (P < 0.05), End diastolic velocity (EDV) and peak systolic velocity (PSV) levels of central retinal artery (CRA) and short posterior ciliary artery (SPCA) were significantly increased while resistance index (RI) level was significantly decreased (P < 0.05). Compared with the control group, the above indicators in the observation group had more significant changes (P < 0.05).Conclusions Tafluprost has obvious clinical effect on patients with primary open-angle glaucoma, and can significantly improve abnormal hemorheological parameters and abnormal levels of endothelial function molecules.

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Section: Analysis Of Clinical Effect Of Ta Uprost On Patients With Pr...supporting

confidence: 86%

Effect of Tafluprost on Endothelial Function-related Molecules and Hemorheological Parameters in Patients with Primary Open-angle Glaucoma

Liu

Nie

et al. 2023

Preprint

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“…These data are reflective of the primary VISIONARY publication and of other real-world data concerning IOP-lowering efficacy with PF tafluprost/timolol FC following a switch away from different topical glaucoma medications [ 22 , 23 ]. Emerging country-level data from the VISIONARY study has revealed differences in baseline IOP, with clinicians in some countries selecting patients with higher IOPs for inclusion in the study [ 31 – 34 ]. As pre-treatment pressure is predictive of IOP change, it is likely that these differences may have influenced the IOP reductions observed in the full Europe-wide dataset, and further subanalysis of these data according to country would be of value [ 16 ].…”

Section: Discussionmentioning

confidence: 99%

Switching to Preservative-Free Tafluprost/Timolol Fixed-Dose Combination in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: Subanalysis of Data from the VISIONARY Study According to Baseline Monotherapy Treatment

Oddone

Fassari

Faschinger³

et al. 2022

Adv Ther

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Introduction The VISIONARY study demonstrated statistically significant intraocular pressure (IOP) reductions with the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (PF tafluprost/timolol FC) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients, sub-optimally controlled with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Current subanalyses have examined these data according to the baseline monotherapy. Methods A European, prospective, observational study included adults (aged ≥ 18 years) with OAG or OHT, who were switched to the PF tafluprost/timolol FC from PGA or beta-blocker monotherapy. Treatment outcomes were reported according to prior monotherapy subgroup: beta-blocker, preserved latanoprost, PF-latanoprost, bimatoprost, tafluprost, and travoprost. Endpoints included the mean change from baseline regarding IOP, conjunctival hyperemia, and corneal fluorescein staining (CFS) at Week 4 and Week 12, and at Month 6. Results The subanalysis included 577 patients. All prior monotherapy subgroups demonstrated statistically significant IOP reductions from baseline at Week 4, that were maintained through Month 6 ( p < 0.001). Mean (SD) IOP change at Month 6 was 6.6 (4.16), 6.3 (4.39), 5.6 (3.67), 4.9 (2.97), 4.6 (4.39), and 4.7 (3.64) mmHg for prior beta-blocker, preserved latanoprost, PF-latanoprost, tafluprost, bimatoprost, and travoprost subgroups, respectively. The largest IOP change was observed in the preserved latanoprost subgroup for each of the ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% IOP reduction categories at Month 6, demonstrating respective reductions of 8.06, 9.20, 10.64, and 11.55 mmHg. CFS was significantly reduced at Month 6 in the prior bimatoprost subgroup ( p = 0.0013). Conjunctival hyperemia severity was significantly reduced at each study visit for prior preserved latanoprost users ( p < 0.001). Conclusion PF tafluprost/timolol FC therapy provided statistically and clinically significant IOP reductions from Week 4 over the total 6-month period, in patients with OAG/OHT, regardless of the type of prior PGA or beta-blocker monotherapy used. Conjunctival hyperemia severity and CFS decreased significantly in prior bimatoprost and preserved latanoprost users, respectively. Clinical Study Number European Union electronic Register of Post-Authorization Studies (EU PAS) register number: EUPAS22204. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02166-6.

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“… 45 Indeed, the relative change in IOP at Month 6 observed in the Italian dataset was slightly greater than the reductions published for Hungary and was similar to those for the UK and Spain where the starting IOP was marginally higher. 41 , 42 , 44 At Month 6, the majority of the Italian ophthalmologists considered PF tafluprost/timolol FC to be associated with better IOP control (78.8%), compared with previous monotherapy, and this is likely to have been supported by the reassuringly high levels of treatment compliance observed by investigators during this real-world study. Change in IOP was significant, regardless of whether patients instilled their medication in the morning or evening.…”

Section: Discussionmentioning

confidence: 67%

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

Oddone¹,

Scorcia²,

Iester³

et al. 2022

OPTH

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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.

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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

Cited by 6 publications

References 55 publications

Effect of Tafluprost on Endothelial Function-related Molecules and Hemorheological Parameters in Patients with Primary Open-angle Glaucoma

Effect of Tafluprost on Endothelial Function-related Molecules and Hemorheological Parameters in Patients with Primary Open-angle Glaucoma

Switching to Preservative-Free Tafluprost/Timolol Fixed-Dose Combination in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: Subanalysis of Data from the VISIONARY Study According to Baseline Monotherapy Treatment

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

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