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1. Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study

Author

Oddone, F., Tanga, L., Kothy, P., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Zimina, M., Erichev, V., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Aguirrec, I. R., Lopez-Lopez, F., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Medina, J. G., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Kirwan, J., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Subjects
Male, 030213 general clinical medicine, Intraocular pressure, genetic structures, Ocular hypertension, Timolol, Glaucoma, 0302 clinical medicine, Prostaglandins, Synthetic, Medicine, Pharmacology (medical), Prospective Studies, Open-angle glaucoma, media_common, Original Research, Aged, 80 and over, Fixed-dose combination, General Medicine, Middle Aged, Drug Combinations, Tolerability, 030220 oncology & carcinogenesis, Female, Glaucoma, Open-Angle, medicine.drug, medicine.medical_specialty, medicine.drug_class, Tonometry, Ocular, 03 medical and health sciences, Preservative-free topical medication, Ophthalmology, Humans, media_common.cataloged_instance, European union, Antihypertensive Agents, Intraocular Pressure, Aged, business.industry, Preservatives, Pharmaceutical, Prostaglandins F, Tafluprost, Correction, medicine.disease, eye diseases, sense organs, Prostaglandin analogue, business
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.

Published
2020

2. Correction to: 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 (Advances in Therapy, (2022), 39, 8, (3501-3521), 10.1007/s12325-022-02166-6)

Author

Oddone, F., Kirwan, J., Lopez-Lopez, F., Zimina, M., Fassari, C., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Erichev, V., Adbulaeva, E., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Rodriguez-Agirretxe, I., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Garcia-Medina, J. J., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Subjects
Pharmacology (medical), General Medicine
Abstract

The authors would like to acknowledge missing data for all prior latanoprost users as a whole. The following sentence has been added to the manuscript (page 8, first paragraph): Mean (SD) reduction from baseline at Month 6 for users of all latanoprost formulations (preserved and PF) was 6.1 (4.25) mmHg (25.9%; p\0.0001). The authors have also prepared a table to summarise the change in intraocular pressure following a switch to the preservative-free tafluprost/timolol fixed-dose combination from all latanoprost formulations (preserved and preservative-free formulations). See Table 1 below.(Table Preseneted.) .The original article has been corrected.

Published
2022

3. 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

Author

Oddone, F., Kirwan, J., Lopez-Lopez, F., Zimina, M., Fassari, C., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Erichev, V., Adbulaeva, E., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Rodriguez-Agirretxe, I., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Garcia-Medina, J. J., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Subjects
Adult, Hyperemia, Tafluprost/timolol fixed-dose combination, Ocular hypertension, VISIONARY study, Travoprost, Preservative-free topical medication, Prostaglandin analogue monotherapy, Humans, Pharmacology (medical), Prospective Studies, Chronic, Open-angle glaucoma, Antihypertensive Agents, Intraocular Pressure, Real-world evidence, Prostaglandins A, Fatigue Syndrome, Chronic, Prostaglandins F, Glaucoma, General Medicine, Beta-blocker monotherapy, Fatigue Syndrome, Drug Combinations, Bimatoprost, Open-Angle, Timolol, Latanoprost, Glaucoma, Open-Angle
Abstract

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

Published
2022

4. Correction to: Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study (Advances in Therapy, (2020), 37, 4, (1436-1451), 10.1007/s12325-020-01239-8)

Author

Oddone, F., Tanga, L., Kothy, P., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Zimina, M., Erichev, V., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Aguirrec, I. R., Lopez-Lopez, F., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Garcia-Medina, J. J., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Kirwan, J., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Published
2020

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