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Ozurdex Implant Approved for Macular Edema

THURSDAY, June 18 -- An injectable eye implant approved by the U.S. Food and Drug Administration Thursday is the first product sanctioned to treat the eye disorder macular edema when it is caused by blockage of the retinal vein, the device's maker said.

The Ozurdex eye implant treats macular edema by delivering a high concentration of the corticosteroid dexamethasone.

Macular edema occurs when the eye's macula -- a part of the retina -- swells because of fluid accumulation from leaking or blocked retinal veins. In a news release, device maker Allergan, Inc. said retinal vein occlusion is a significant cause of vision loss and the second most common disease of the retinal veins, behind diabetic retinopathy.

The implant, which is biodegradable, was evaluated in a pair of clinical studies involving about 1,300 people.

The treatment, to be injected in a physician's office, is expected to be available later this year, Allergan said.

Common adverse reactions observed during clinical testing included increased pressure, eye pain, cataract and headache.

More information

To learn more about macular edema, visit the U.S. National Eye Institute.

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Posted: June 2009