TY - JOUR

T1 - Switching to Preservative-Free Tafluprost/Timolol Fixed-Dose Combination in the Treatment of Open-Angle Glaucoma or Ocular Hypertension

T2 - Subanalysis of Data from the VISIONARY Study According to Baseline Monotherapy Treatment

AU - Oddone, Francesco

AU - Kirwan, James

AU - Lopez-Lopez, Fernando

AU - Zimina, Marina

AU - Fassari, Claudia

AU - Holló, Gábor

AU - Faschinger, Christoph

AU - Chen, Enping

AU - Holló, Gábor

AU - Nemeth, Gabor

AU - Bator, Gyorgy

AU - Tsorbatzoglou, Alexis

AU - Acs, Tamas

AU - Ferencz, Maria

AU - Sohajda, Zoltán

AU - Toth, Jeno

AU - Volner, Veronika

AU - Vogt, Gábor

AU - Biro, Zsolt

AU - Facskó, Andrea

AU - Nemes, János

AU - Berta, Andras

AU - Elek, Ilona

AU - Ng, Eugene

AU - Oddone, Francesco

AU - Rossi, Gemma

AU - Rossetti, Luca

AU - Vetrugno, Michele

AU - Iester, Michele

AU - Marchini, Giorgio

AU - Scorcia, Vincenzo

AU - Staurenghi, Giovanni

AU - Cagini, Carlo

AU - Salgarello, Tommaso

AU - Bettin, Paolo

AU - Figus, Michele

AU - Scuderi, Gian Luca

AU - De Cilla, Stefano

AU - Grundmane, Iveta

AU - Linavska, Nora

AU - Volksone, Lasma

AU - Laganovska, Guna

AU - Baumane, Kristine

AU - Lemij, Hans

AU - Gundersen, Kjell Gunnar

AU - Erichev, Valery

AU - Adbulaeva, Elmira

AU - Karlova, Elena

AU - Zakharova, Ekaterina

AU - Kolko, Miriam

AU - The VISIONARY Study Group

N1 - Funding Information: Sponsorship for this study, publication fees (Rapid Service and Open Access), and medical writing fees were provided by Santen SA. The contribution of IRCCS Fondazione Bietti to this work was supported by the Italian Ministry of Health and by Fondazione Roma. Publisher Copyright: © 2022, The Author(s).

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - Beta-blocker monotherapy

KW - Ocular hypertension

KW - Open-angle glaucoma

KW - Preservative-free topical medication

KW - Prostaglandin analogue monotherapy

KW - Real-world evidence

KW - Tafluprost/timolol fixed-dose combination

KW - VISIONARY study

U2 - 10.1007/s12325-022-02166-6

DO - 10.1007/s12325-022-02166-6

M3 - Journal article

C2 - 35524840

AN - SCOPUS:85133836070

VL - 39

SP - 3501

EP - 3521

JO - Advances in Therapy

JF - Advances in Therapy

SN - 0741-238X

IS - 8

ER -