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Efficacy and safety of fixed-combination brimonidine tartrate/timolol maleate in primary open-angle glaucoma, including normal-tension glaucoma

  • Clinical Investigation
  • Published:
Japanese Journal of Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

To assess the 12-month efficacy and safety of fixed-combination brimonidine tartrate 0.2%/timolol maleate 0.5% (FCBT) with or without bimatoprost 0.01% (BIM) in primary open-angle glaucoma (POAG), including normal-tension glaucoma (NTG).

Study design

Prospective, multicenter, open-label study.

Methods

FCBT was self-administered twice daily after applicable washout (study eye). Intraocular pressure (IOP) was measured at baseline and months 1, 3, 6, 9, and 12. BIM could be added for IOP ≥ 21 mmHg, IOP reduction from baseline < 20%, or the investigator deemed it necessary. Primary endpoint: mean (11-a.m.) month-12 IOP change from baseline. Secondary endpoints included mean IOP changes from baseline at other visits, median time to achieving and patients (%) achieving target IOP reduction with FCBT, and visual field (VF) progression rate over 12 months. Safety was assessed at each visit.

Results

Of 118 eyes with POAG (NTG, n = 93), 87 used FCBT; 31 required FCBT + BIM. Mean IOP changes from baseline (16.8 and 15.3 mmHg) to month 12 were − 4.1 mmHg (FCBT, n = 62) and − 3.5 mmHg (FCBT + BIM, n = 15), respectively (both P < 0.0001). Patients who achieved target IOP reduction with FCBT did so in 1 month (median). VF progression rates were 0.17%/year (FCBT, P = 0.8367) and − 0.08%/year (FCBT + BIM, P = 0.9410). Ocular treatment-emergent adverse events occurred in 42.5% (FCBT) and 71.0% (FCBT + BIM) of patients; most were mild and included ocular hyperemia (9.2% and 41.9%, respectively).

Conclusions

Despite low mean baseline IOP, ≥ 20% IOP reduction from baseline persisted over 12 months with FCBT and FCBT + BIM, without clinically significant VF progression. Tolerability was consistent with reported drug safety profiles.

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Acknowledgements

This study was sponsored by Allergan (prior to its acquisition by AbbVie). The funding body was involved in the study design, data analysis and interpretation, manuscript revision for intellectual content, and decision to submit the manuscript for publication. Writing and editorial assistance were provided to the authors by Michele Jacob, PhD, CMPP, of Evidence Scientific Solutions, Philadelphia, PA, and funded by Allergan, an AbbVie company. Neither honoraria nor payments were made for authorship. Assistance with study monitoring and statistical/data management was provided by LSK Global Pharma Services Co., Ltd. The authors also thank Youkyung Lee, MD (employee of Allergan at the time the study was conducted) for her contribution to study protocol and clinical study report. Study group investigators: Ki Ho Park (Seoul National University Hospital), Tae-Woo Kim (Seoul National University Bundang Hospital), Joon Mo Kim (Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine), Yung Hoon Hwang (Kim’s Eye Hospital), Chan Kee Park (The Catholic University of Korea Seoul St. Mary’s Hospital), Kyoung Nam Kim (Chungnam National University Hospital), Soon Cheol Cha (Yeungnam University Medical Center), Sang Woo Park (Chonnam National University Hospital), Ji Woong Lee (Pusan National University Hospital).

Author information

Authors and Affiliations

  1. Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea

    Sang Woo Park

  2. Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea

    Joon Mo Kim

  3. Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea

    Ji Woong Lee

  4. Medical Affairs, Allergan (an AbbVie company), Singapore, Singapore

    Joy Maglambayan & Susan Simonyi

  5. Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea

    Ki Ho Park

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Correspondence to Ki Ho Park.

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Conflicts of interest

The conflicts of interest for S. W. Park, None; J. M. Kim, None; J. W. Lee, None; J. Maglambayan, Employee (AbbVie); S. Simonyi, Employee (AbbVie); K. H. Park, None.

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This work was partially presented at the 122nd Annual Meeting of the Korean Ophthalmology Society (KOS) 2019 meeting (November 1–3, 2019, Seoul, Korea), Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting (April 28–May 2, 2019, Vancouver, Canada), and Controversies in Ophthalmology 5th Asia-Australia (COPHy–AA) Congress (February 22 –23, 2019, Shanghai, China).

Corresponding Author: Ki Ho Park.

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Park, S.W., Kim, J.M., Lee, J.W. et al. Efficacy and safety of fixed-combination brimonidine tartrate/timolol maleate in primary open-angle glaucoma, including normal-tension glaucoma. Jpn J Ophthalmol 65, 295–305 (2021). https://doi.org/10.1007/s10384-020-00796-3

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