Alcon announced that the FDA has approved Simbrinza (brinzolamide/brimonidine tartrate) Suspension indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Simbrinza Suspension is a fixed-dose combination of brinzolamide, a carbonic anhydrase inhibitor, and brimonidine tartrate, an alpha-2 adrenergic receptor agonist. Brinzolamide inhibits carbonic anhydrase in the ciliary processes of the eye to decrease aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. 

Brimonidine tartrate is presumed to have a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow. Its peak ocular hypotensive effect occurs at two hours post-dosing.

The approval of Simbrinza is based on data from two Phase III clinical trials (approximately 1,300 patients) that evaluated the safety and efficacy of a fixed-dose combination of brinzolamide 1.0% and brimonidine 0.2%, given three times daily, compared to separate three times daily dosing of either components. Both studies met their primary endpoint and Simbrinza demonstrated it was statistically superior compared to either component regarding mean IOP (5–9mmHg reduction) at Month 3 for all time points.

Simbrinza Suspension will be available as a 1%/0.2% concentration in a 10mL bottle.

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