Abstract
PurposeTo determine whether intraocular pressure (IOP) lowering with fixed-combination brinzolamide/brimonidine (BBFC) adjunctive to a prostaglandin analog (PGA) was superior to that of vehicle+PGA in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled with PGA monotherapyMethodsThis 6-week, multicenter, randomized, double-masked, parallel-group trial was conducted at 30 clinical sites in the United States between October 2013 and May 2014. Eligible patients were adults with open-angle glaucoma or ocular hypertension and with mean IOP ≥21 and <32 mm Hg, whereas receiving an open-label PGA (latanoprost, bimatoprost, or travoprost). Patients instilled a PGA once-daily in a run-in phase before randomization to masked BBFC or vehicle adjunctive treatment. Masked treatments were instilled 3 times daily for 6 weeks, and patients continued once-daily use of their PGA. The primary efficacy end point was the between-group difference in mean diurnal IOP (average of 0800, 1000, 1500, and 1700 hours time points) at week 6.ResultsAt week 6, mean diurnal IOP with BBFC+PGA was lower than with vehicle+PGA (17.1±0.4 mm Hg vs 20.5±0.4 mm Hg; between-group difference, −3.4±0.5 mm Hg; P<0.0001; 95% confidence interval, −4.5 to −2.4 mm Hg). BBFC+PGA reduced mean diurnal IOP by 5.7 mm Hg (25%) from the baseline IOP achieved with PGA monotherapy.ConclusionsTherapy with BBFC produced an additive IOP-lowering effect compared with a PGA alone or in conjunction with vehicle. BBFC may provide an effective treatment option for patients receiving PGA monotherapy who require additional IOP reduction.
Highlights
Insufficient intraocular pressure (IOP) control is a primary risk factor for progression of ocular hypertension and glaucoma,[1] and elevated IOP is associated with increased risk for vision loss.[2]
The objective of this study was to determine whether IOP lowering with Brinzolamide 1%/brimonidine 0.2% fixedcombination ophthalmic suspension (BBFC) adjunctive to prostaglandin analog (PGA) (BBFC+PGA) was superior to that of vehicle+PGA in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled with PGA monotherapy
One patient randomized to BBFC+PGA did not receive study medication and was excluded from the intent-to-treat and safety analyses
Summary
Insufficient intraocular pressure (IOP) control is a primary risk factor for progression of ocular hypertension and glaucoma,[1] and elevated IOP is associated with increased risk for vision loss.[2] Prostaglandin analogs (PGAs) are highly effective first-line therapies for lowering IOP.[3] As many as 50% of patients in the Ocular Hypertension Treatment Study required additional ocular hypotensive medications to maintain IOP reduction after the first year of treatment.[4] the safety and efficacy of adding a fixed-combination medication containing timolol to prostaglandin monotherapy have been demonstrated,[5,6,7] data are needed to evaluate the addition of a fixed combination without a β-blocker to PGAs. Brinzolamide 1%/brimonidine 0.2% fixedcombination ophthalmic suspension (BBFC; SIMBRINZA, Alcon Laboratories, Fort Worth, TX, USA) is currently the only fixed-combination glaucoma therapy that does not contain a β-blocker.[8] In randomized, double-masked trials, treatment with BBFC 2 times daily (BID; approved dosing in most countries) or 3 times daily (approved dosing in the United States) significantly reduced IOP by ~ 20–35% from baseline, and BBFC was more effective than either of its components.[9,10,11,12,13]
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