Spreading agent given marketing exclusivity

Irvine, CA-The FDA is giving ISTA Pharmaceuticals Inc. 3 years of marketing exclusivity for hyaluronidase for injection (Vitrase) for use as a spreading agent to facilitate the dispersion and absorption of other injected drugs.

The marketing exclusivity means the FDA will not approve any other hyaluronidase in the United States until May 5, 2007. The compound previously was on the FDA's list of drug shortages.

ISTA Pharmaceuticals has made the drug available to physicians free of charge while it prepares for approval of a smaller 150 USP units/ml vial that is expected to be more convenient and cost effective. The company expects approval of the smaller unit size later this year with a full marketing launch in early 2005.

"We are proud of our work with Allergan and pleased that our new agreement allows us to continue our relationship," said ISTA President and CEO Vicente Anido Jr. "For ISTA, our reacquisition of U.S. marketing rights to Vitrase for the posterior segment of the eye is another important step in our growth as a specialty pharmaceutical company focused on ophthalmology."