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FDA approves Simbrinza suspension to reduce IOP

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The U.S. Food and Drug Administration approved Simbrinza suspension, a fixed-dose combination therapy without a beta blocker, to reduce IOP in patients with primary open-angle glaucoma or ocular hypertension, according to a press release from Alcon.

The suspension combines brimonidine tartrate 0.2%, an alpha 2 adrenergic receptor agonist, and brinzolamide 1%, a carbonic anhydrase inhibitor, in a multi-dose bottle, which patients are to administer three times each day.

Two pivotal phase 3 clinical trials of the suspension served as the primary basis for approval, the release said. In the trials, Simbrinza was analyzed for safety and efficacy in comparison with each of its components administered three times per day in 1,300 patients over a 3-month period.

In both studies, the fixed-dose suspension demonstrated statistical superiority over the individual components in relation to patients’ mean IOP at 3 months.