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Novartis Unit Announces FDA Approval Of Simbrinza Suspension

Eye care company Alcon, a part of Swiss drug giant Novartis AG (NVS), Friday announced US Food and Drug Administration approval for Simbrinza Suspension, indicated for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

Elevated intraocular pressure, or IOP, is the only modifiable risk factor for glaucoma, a group of eye diseases that lead to progressive damage of the optic nerve and can result in gradual, irreversible loss of vision, and eventually blindness, if left untreated. Glaucoma affects more than 2.2 million Americans and is the second-leading cause of preventable blindness worldwide.

Simbrinza is a fixed-dose combination medication that offers a wide range of treatment possibilities due to its strong efficacy and ability to decrease elevated IOP by 21- 35% In addition, it is the only available, fixed-dose combination therapy for glaucoma in the US without a beta blocker.

The new ophthalmic suspension is a fixed-dose combination of a carbonic anhydrase inhibitor (Brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (Brimonidine Tartrate 0.2%). It combines the two drugs into one multi-dose bottle, helping to reduce the medication burden for glaucoma patients.

The FDA approval of Simbrinza is based on data from two pivotal Phase III clinical trials with about 1,300 patients. The studies evaluated the safety and efficacy of a fixed-dose combination of Brinzolamide 1.0% and Brimonidine 0.2%, administered three times daily, compared to separate three- times-per-day dosing of one or the other component. Both studies met their primary endpoint and demonstrated that Simbrinza is statistically superior compared to either component regarding mean IOP at Month 3 for all time points.

The most frequently reported adverse reactions in patients treated with Simbrinza were blurred vision, eye irritation, dysgeusia (bad taste), dry mouth and eye allergy.

by RTT Staff Writer

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