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FDA approves Novartis' Simbrinza for glaucoma

World News | April 22, 2013


Kevin Grogan

FDA approves Novartis' Simbrinza for glaucoma

Regulators in the USA have given the green light to Simbrinza, a glaucoma treatment developed by Novartis eye care unit Alcon.

The US Food and Drug Administration has approved Simbrinza for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. The drug combines brinzolamide and brimonidine and the thumbs-up means it is the only available, fixed-dose combination therapy for glaucoma in the USA without a beta blocker.

The approval is based on Phase III studies which show that the combination is more effective than either of the aforementioned already-approved agents taken alone. It combines the two drugs into one multi-dose bottle, helping to reduce the medication burden for glaucoma patients as they administer one drop of Simbrinza into the affected eye(s) three times per day.

Robert Warner, president of Alcon in the USA and Canada, said that "Simbrinza has the potential to re-shape the treatment paradigm for glaucoma". The company also quoted Gregory Katz of the St Joseph Mercy Medical Center in Ann Arbor, Michigan, as saying that "it's exciting to now have a product available that combines two effective compounds into one multi-dose combination, offering sustained control".

More than 67 million people worldwide have glaucoma, which is the second-leading cause of preventable blindness.

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