June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Efficacy and safety of fixed-dose combination brinzolamide 1%/brimonidine 0.2% as adjunctive therapy to prostaglandin analogs in patients with elevated intraocular pressure: Results from pooled analysis of two multicenter, randomized studies
Author Affiliations & Notes
  • Doug Hubatsch
    Novartis Pharmaceutical Corporation, Fort Worth, Texas, United States
  • Tony Realini
    Department of Ophthalmology, West Virginia University, Morgantown, West Virginia, United States
  • Footnotes
    Commercial Relationships   Doug Hubatsch, Novartis Pharmaceutical Corporation (E); Tony Realini, Alcon (C), Bausch and Lomb (C), Inotek (C), Smith and Nephew (C)
  • Footnotes
    Support  The study was sponsored by Alcon Research, Ltd., Fort Worth, Texas
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2100. doi:
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      Doug Hubatsch, Tony Realini; Efficacy and safety of fixed-dose combination brinzolamide 1%/brimonidine 0.2% as adjunctive therapy to prostaglandin analogs in patients with elevated intraocular pressure: Results from pooled analysis of two multicenter, randomized studies. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2100.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Brinzolamide 1%/brimonidine 0.2% fixed combination (BBFC) is an effective intraocular pressure (IOP)-lowering therapy in adult patients with open-angle glaucoma or ocular hypertension. Here, we discuss the pooled analysis of two studies that evaluated the IOP lowering efficacy and safety of BBFC when added to prostaglandin analog (PGA) therapy in patients with open-angle glaucoma or ocular hypertension.

Methods : Both were multicenter, randomized, double-masked, parallel-group studies conducted in the United States (study 1, NCT01937299; study 2, NCT01937312). Patients discontinued prior glaucoma medications and received once-daily PGA (study 1: travoprost 0.004%; study 2: latanoprost 0.005%, bimatoprost 0.01%, or travoprost 0.004%) for a four-week run-in period. Eligible patients were randomized to BBFC or a vehicle thrice-daily along with PGA once-daily for six weeks. Key efficacy endpoints were (1) mean diurnal IOP and between-group difference in mean diurnal IOP at week 6 and (2) mean diurnal IOP change, and mean between-group difference in diurnal IOP change from baseline to week 6. Adverse events (AEs) were monitored in both studies.

Results : In all, 411 patients were included in the intent-to-treat population (BBFC+PGA, n=201; vehicle+PGA; n=210). Mean patient age was 66.0 years, 61.3% patients were female and 74.9% were diagnosed with open-angle glaucoma. Mean diurnal IOP at baseline was 22.6±2.3 mmHg with BBFC+PGA and 22.5±2.6 mmHg with vehicle+PGA. Least squares (LS) mean ± standard error (SE) diurnal IOP at week 6 was 17.3±0.3 mmHg with BBFC+PGA and 20.5±0.3 mmHg with vehicle+PGA. Between-group difference was −3.3±0.4 mmHg (P<0.0001). LS mean ± SE diurnal IOP reduction from baseline to week 6 was −5.4±0.3 mmHg vs. −2.1±0.2 mmHg (difference, −3.3±0.3 mmHg; P<0.0001) with BBFC+PGA vs. vehicle+PGA, respectively. The most common treatment-emergent AE was blurred vision (BBFC+PGA, 7.6%; vehicle+PGA, 5.2%). AE-related study discontinuations were reported for 11% and 0.5% patients receiving BBFC+PGA and vehicle+PGA, respectively.

Conclusions : Treatment with BBFC in combination with PGA is effective and shows an additive effect in lowering IOP. AEs were similar to the known BBFC and PGA safety profiles.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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