COMMENTARY

A New Fixed-Combination Glaucoma Medication

Shuchi B. Patel, MD

Disclosures

December 16, 2013

Six-Month Results from a Phase III Randomized Trial of Fixed-Combination Brinzolamide 1% + Brimonidine 0.2% Versus Brinzolamide or Brimonidine Monotherapy in Glaucoma or Ocular Hypertension

Whitson JT, Realini T, Nguyen QH, McMenemy MG, Goode SM
Clin Ophthalmol. 2013;7:1053-1060

Study Summary

The first fixed-combination antihypertensive medication for glaucoma without a beta-blocker was recently made available. The brinzolamide 1% and brimonidine 0.2% fixed combination (BBFC) is made by Alcon. Compared with previous combination medications, it can be administered 3 times daily.

An Alcon-sponsored randomized, multicenter, double-masked, 3-month, 3-arm study with a 3-month safety extension to compare the efficacy of the combination vs each individual medication was performed. Patients were randomly assigned in a 1:1:1 ratio to receive treatment with BBFC, brinzolamide 1%, or brimonidine 0.2% after a washout period that was dependent on the previously used medication. Patients administered their study medications 3 times daily for 6 months.

Intraocular pressure (IOP) measurements were used to assess efficacy at 2 weeks, 6 weeks, 3 months, and 6 months. At each visit, investigators assessed IOP in both eyes at 8:00 AM, 10:00 AM, 3:00 PM, and 5:00 PM. Safety assessments were adverse events, corrected distance visual acuity, slit-lamp biomicroscopy, pachymetry, perimetry, fundus parameters, and cardiac parameters.

A total of 690 patients were enrolled. Inclusion required a pretreatment IOP of 24-36 mm Hg at the first visit and an IOP of at least 21 mm Hg at the second eligibility visit. Patients dosed both eyes with the study medications at fixed times (± 30 minutes) of 8:00 AM, 3:00 PM, and 10:00 PM for 6 months.

Mean IOP values at 6 months were similar to those at 3 months for each treatment group at each time point. The percentage decline in IOP at 6 months compared with baseline ranged from 20% to 30.7% for BBFC, 16.4% to 22% for brinzolamide, and 12.4% to 24.8% for brimonidine. Absolute IOP reductions from baseline to 6 months ranged from 4.9 to 8 mm Hg for BBFC, 4.1 to 5.8 mm Hg for brinzolamide, and 3 to 6.3 mm Hg for brimonidine, across all 4 time points.

At least 1 treatment-related adverse event was experienced by 175 patients (BBFC, 33%; brinzolamide, 18.8%; brimonidine, 24.7%), of which 8 were severe and 5 resulted in discontinuation. In all, 77 patients discontinued participation owing to treatment-related adverse events (BBFC, 17.2%; brinzolamide, 2.1%; brimonidine, 14.5%). Resting mean pulse and blood pressure with BBFC were similar to those with brimonidine, demonstrating modest, clinically insignificant reductions. No new or increased risks were identified with use of BBFC relative to either monotherapy.

In conclusion, the safety profile of BBFC is similar to that of its individual components, and its IOP-lowering activity is superior to either brinzolamide 1% or brimonidine 0.2% alone.

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