Early Clinical Experiences with Brinzolamide/Brimonidine Fixed Combination in Open-angle Glaucoma and Ocular Hypertension

Abstract

T he fixed combination of brinzolamide 10 mg/ml and brimonidine 0.2% 2 mg/ml (BBFC; Simbrinza ® ) is an important addition to the glaucoma treatment choices currently available. Glaucoma is an increasingly prevalent disease worldwide, particularly in the elderly, and causes a serious burden of blindness. Fixed combinations of eye drops simplify treatment regimens, improving compliance, which helps maintain intraocular pressure (IOP) reductions. Registration of BBFC in Europe was supported by two phase III trials. In the first (n=560), after 6 months of treatment, BBFC twice daily lowered IOP by -1.4 mmHg more than brinzolamide alone, and by -1.5 mmHg more than brimonidine alone (least squares mean differences, p<0.0001 for both versus BBFC). BBFC was well tolerated with a safety profile similar to its two components. In the other of these trials (n=411), BBFC was non-inferior to brinzolamide and brimonidine given as separate doses concomitantly (B + B). The adverse events were similar in each group, with a slightly higher incidence in the B + B group. In the US, registration of BBFC in glaucoma was supported by three phase III and one phase IV trials, which also showed significantly greater IOP reduction with BBFC compared with its components alone and showed similar safety profiles. Additional phase IV studies are in progress to evaluate the combined use of BBFC with travoprost and timolol. BBFC has been clinically available in the US and Europe for only a short time, but its clinical trial efficacy suggests it will have a positive impact on real-world glaucoma and may have utility for earlier administration than its current third-or fourth-line use.