14/11/2011 - 15:43

pSivida plunges on FDA knock-back

14/11/2011 - 15:43


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pSivida plunges on FDA knock-back

Stocks in Perth-based biotech pSivida have halved in value after the United States Food and Drug Administration declined to approve its treatment for back-of-the-eye problems associated with diabetes.

At close of trade today pSivida’s stock had lost 48.7 per cent, to trade at $2.10.

The FDA said there was not sufficient data to prove that pSivida’s ILUVIEN treatment of diabetic macular edema associated with diabetic retinopathy was safe and effective.

According to the FDA, adverse reactions to the treatment were significant, and were not offset by the benefits of the drug.

“We are obviously surprised and disappointed with the FDA’s decision,” pSivida chief executive Paul Ashton said.

A decision on whether the treatment will be made available in Europe is expected in the first half of next year.


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