Ista wins U.S. panel support for eye itch drug Print E-mail
By Staff and Wire Reports   
Friday, 26 June 2009 11:01 - Ista wins U.S. panel support for eye itch drugSILVER SPRING, Md., (Reuters) - A proposed drug from Ista Pharmaceuticals Inc (Nasdaq: ISTA) won unanimous support from a U.S. advisory panel on Friday for treating itchiness in the eye caused by allergies.

Ista shares jumped on Nasdaq.

The committee of Food and Drug Administration advisers voted 7-0 that Ista had adequately demonstrated the safety and effectiveness of the Bepreve eye drops, which would be sold by prescription if the agency granted final approval.

Studies by Ista "all deliver the same message and that's in support of safety and effectiveness," said panel member Philip Lavin, executive chairman of Averion International Corp, a clinical research organization.

The FDA usually approves drugs recommended by advisory panels. A final decision is due by Sept. 12, although the FDA has missed several target dates over the past year.

SunTrust Robinson Humphrey analyst Frank Pinkerton has forecast Bepreve sales would be $12 million in 2010 if the drug won approval for U.S. sales.

Several medicines are approved for treating allergies, but Ista said there was a need for new options with fewer side effects. Approved drugs may cause sleepiness, dry mouth and other problems.

The most frequent side effect reported in studies of Bepreve was changes in taste, such as a bitter taste or aftertaste. Ista officials said cases were mild and transient.

Ista said in a statement: "We believe people who suffer from itchy eyes due to allergies will be pleased to have access to a new therapeutic option" should the drug be cleared for sale.

The committee was set to vote later Friday on whether a drug from River Plate Biotechnology was safe and effective for treating dry eye. Alcon Inc (NYSE: ACL) holds U.S. marketing rights to the product, called Rejena. (Reporting by Lisa Richwine; editing by Gerald E. McCormick and Lisa Von Ahn)

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