Ista Jumps on FDA OK

The company's new inflammation drug is approved by the Food and Drug Administration.
By Althea Chang ,

Ista Pharmaceuticals

(ISTA)

shares were up on high volume after the company announced that its new inflammation drug was approved by the Food and Drug Administration.

Shares were up 41 cents, or 4.2%, to $10.25 in more than six times their average daily trading volume of some 88,000.

Ista's Xibrom ophthalmic drops are the first twice-daily ophthalmic non-steroidal antiinflammatory solution to be approved in the U.S. Xibrom is approved to treat inflammation after cataract surgery. In phase III trials, the last round of trials submitted before seeking regulatory approval, a study of 527 patients showed that the drug was effective in eliminating eye inflammation after three days.

Dosages for similar drugs currently on the market are four times a day. Fewer doses improve patients' compliance with the prescribed use of the medication.

Irvine, Calif.-based Ista expects to launch Xibrom during the second quarter of this year, after manufacturing and further sales force recruiting, says Dr. Vicente Anido Jr., president and chief executive officer. The company and IMS Health say the ophthalmic antiinflammatory market brings in about $250 million a year.

Xibrom has been marketed in Japan by Senju Pharmaceuticals. Ista received marketing rights for the drug in 2002.

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