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Ista Shares Plunge After FDA Review

March 19, 2003|From Bloomberg News

Shares of Ista Pharmaceuticals Inc. fell 14% on Tuesday after a U.S. government panel said the company didn't prove the effectiveness of its first drug, a treatment for eye bleeding in diabetics.

A Food and Drug Administration panel voted 8 to 4 on Monday that Ista, based in Irvine, failed to submit sufficient evidence to support the company's claims about the experimental medicine's effectiveness.

The drug, called Vitrase, did have benefits that outweighed any risks and may help some patients, the committee said. Panel members asked for more data on how the medicine works.

The FDA will consider the committee's comments before deciding whether to approve Vitrase.

In studies, Vitrase did improve patients' vision and cleared bleeding to allow doctors to see into the back of the eye to provide some treatment.

The drug failed to meet a primary goal of clearing the hemorrhage enough to allow doctors to complete treatment of the underlying cause of the bleeding, the panel said.

Shares of Ista fell 90 cents to $5.65 in Nasdaq trading.

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