Source: DGNews  |  Posted 3 years ago

NEW YORK -- December 3, 2008 -- The European Medicines Agency has approved the fixed combination brinzolamide 10 mg/mL plus timolol 5 mg/mL (Azarga) ophthalmic suspension for the treatment of elevated intraocular pressure (IOP) associated with open-angle glaucoma or ocular hypertension in adult patients for whom monotherapy provides insufficient IOP reduction.

The approval is based on 2 studies that showed brinzolamide/timolol to be more comfortable and better tolerated by patients than dorzolamide plus timolol (Cosopt). In a patient preference study comparing the 2 solutions, 79% of patients with glaucoma expressed a preference to brinzolamide/timolol.

The studies also showed that the active ingredients in the brinzolamide/timolol suspension were more effective when delivered in combination than either of them individually.

Brinzolamide/timolol demonstrated superior IOP-lowering efficacy at every time point measured in the study versus the individual components alone, while demonstrating a similar safety profile. In addition, a head-to-head study showed that brinzolamide/timolol provides IOP lowering efficacy that is similar to dorzolamide/timolol.

SOURCE: Alcon, Inc.