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FDA NEWS RELEASE

For Immediate Release: Feb. 14, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Zioptan to treat elevated eye pressure
Drug provides potentially sight-saving treatment for those with glaucoma

On February 10, the U.S. Food and Drug Administration approved Zioptan (tafluprost ophthalmic solution) to help reduce elevated eye pressure in people with open-angle glaucoma.

The drug is also approved for use in patients with higher-than-normal eye pressure (ocular hypertension), an important risk factor for glaucoma, the second leading cause of blindness in the United States. Patients with ocular hypertension frequently are considered to have a greater chance of developing glaucoma.

“Zioptan’s approval provides an alternative treatment option for patients living with this potentially blinding disease,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.

Zioptan is an eye drop that should be used once daily in the evening. In clinical studies up to 24 months in duration, patients with open-angle glaucoma or ocular hypertension treated with Zioptan in the evening showed reduced eye pressure at three and six months.

People using Zioptan may see darkening of the iris, which may be permanent, and darkening of the eyelid, which may be reversible. Those using the drug also experience eyelash growth.

Zioptan is marketed by Whitehouse Station, N.J.-based Merck & Co. Inc.

For more information:

FDA Approved Drugs: Questions and Answers
 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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