FDA panel endorses drug for age-related eye problem
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FDA panel endorses drug for age-related eye problem

www.reuters.com   | 27.07.2012.

WASHINGTON (Reuters) - A Food and Drug Administration panel on Thursday recommended ThromboGenics NV's ocriplasmin as a treatment for vitreomacular adhesion, an aging-related vision problem that can lead to blindness.
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The FDA advisory committee of outside experts concluded that the injectable drug, marketed under the brand name Jetrea, helped enough people in clinical trials to warrant a favorable review, despite evidence of adverse effects including eye pain, swelling and blurred vision.

Several panel members recommended further studies to monitor safety and determine more fully the drug's effectiveness.

The recommendations will now be considered by U.S. health regulators, who must decide whether to approve the treatment for sale in the United States.

The Belgian biotech company's shares closed 4.82 percent lower at 23.30 euros before the panel voted on the drug.

The company has secured a deal to sell ocriplasmin in 40 countries outside the United States through Novartis AG's opthalmic division, Alcon.

ThromboGenics plans to market the product itself within the United States.

(Reporting by David Morgan; editing by Gary Hill and Andre Grenon)



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