The US Food and Drug Administration (FDA) has approved a suspension of brimonidine and brinzolamide ( Simbrinza , Alcon, a division of Novartis) for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension, according to an April 19 statement from the manufacturer.
Simbrinza combines a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%) in a single multidose bottle, reducing the medication burden for patients with glaucoma. It is the only beta blocker–free, fixed-combination therapy for glaucoma available in the United States.
"Simbrinza represents an important new option for treating glaucoma patients with elevated IOP," Gregory Katz, MD, from the Glaucoma Service, St. Joseph Mercy Medical Center, Ann Arbor, Michigan, noted in the Novartis news release. "Glaucoma must be treated over the course of one's life, and elevated eye pressure must be managed every day. It's exciting to now have a product available that combines two effective compounds into one multi-dose combination, offering sustained control," Dr. Katz explained in the release.
The FDA approval is based on results from 2 pivotal phase 3 clinical trials including approximately 1300 patients, each conducted over the course of 3 months. The trials evaluated the safety and efficacy of the new combination drug given 3 times daily compared with separate 3-times-daily administration of either brinzolamide 1.0% or brimonidine 0.2%.
In both studies, the primary endpoint was met and the new drug was shown to be statistically superior compared with either single component at reducing IOP at month 3 for all times studied. In both studies, the new combination drug reduced IOP by from 5 to 9 mm Hg from baseline to month 3. At baseline, patients' mean IOP was between 22 and 36 mm Hg.
In both clinical trials, the most frequent adverse reactions in the Simbrinza group were blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, and eye allergy, in descending order of incidence. The adverse reactions occurred in approximately 3% to 5% of patients.
Approximately 11% of patients receiving the new combination drug discontinued treatment primarily because of adverse reactions. The drug's safety profile is comparable to each of the single components, and no significant cardiovascular or pulmonary events were found with it in either clinical trial.
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Cite this: FDA Approves Simbrinza for Glaucoma, Ocular Hypertension - Medscape - Apr 24, 2013.