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Jason Bacharach, Douglas A Hubatsch, Howard Barnebey; Subgroup Analysis of the IOP-Lowering Effect of Fixed-Combination Brinzolamide 1%/Brimonidine 0.2% in the 3-Month Study NCT01297517. Invest. Ophthalmol. Vis. Sci. 2014;55(13):556.
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To determine if intraocular pressure (IOP)-lowering effect observed with fixed-dose combination brinzolamide 1%/brimonidine 0.2% (BBFC) in the full NCT01297517 study cohort was consistent across different subgroups.
NCT01297517 was one of two phase 3, parallel-arm, double-masked, multicenter, 3-month studies used for regulatory approval of BBFC. This preplanned descriptive statistical analysis compared IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) across the following subgroups after 3 months of treatment: (1) baseline intraocular pressure (24-27 or 28-36 mmHg), (2) age (<65, >65, 65-75, 75-85 years), (3) gender, and (4) ethnicity. IOP was recorded at 8 am, 10 am, 3 pm, and 5 pm.
A total of 660 patients were enrolled in the original study, and IOP lowering with BBFC was statistically superior to the components at all time points. Subgroup analyses of IOP at 8 am (10-hour trough IOP) after 3 months of treatment are reported in this abstract. Mean IOP in high/low baseline IOP BBFC arm subgroups ranged from 18.4±2.97 to 22.9±4.56 mmHg. In comparison, mean IOP ranged from 19.7±3.64 to 23.5±4.14 mmHg in the brinzolamide arm and from 20.9±3.71 to 26±3.83 mmHg in the brimonidine arm. The lower and higher ends of each range are mean IOPs for subgroups with baseline IOP of 24-27 mmHg and 28-36 mmHg, respectively. Patients aged 65-75 years had mean IOP levels of 19.6±3.87, 20.2±4.00 and 22.8±4.63 mmHg with BBFC, brinzolamide, and brimonidine, respectively; patients aged 75-85 years showed mean IOP levels of 20.4±4.03, 20.5±3.81, and 22.5±3.89 mmHg in each of the arms at 8 am. There was no apparent gender bias in efficacy of BBFC compared with its components, nor was there a bias toward any particular ethnic group (Caucasian, African American or Hispanic). The AE profile of BBFC was similar to that of the components. This subgroup efficacy analysis demonstrated that BBFC has a similar IOP profile across all subgroups analyzed as was observed in the full cohort. IOP with BBFC was lower than with the individual components across all time points and all subgroups analyzed.
BBFC is an effective IOP-lowering therapy for patients with OAG or OHT irrespective of baseline IOP, age, sex and ethnicity (Caucasian, African American or Hispanic).
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