ISTA Pharmaceuticals, Inc. (ISTA) will begin the process of unmasking data and initiating the analysis of its Phase III studies of Vitrase for the treatment of severe vitreous hemorrhage. The company's analysis will examine both the primary surrogate endpoint (vitreous hemorrhage clearing) and other clinically relevant parameters.

Until now, the study data have not been seen or reviewed by executives at ISTA or representatives of the U.S. Food and Drug Administration (FDA).

"We have taken into consideration the FDA's comments in making adjustments to our statistical analysis plan and submitted the changes to the FDA. In addition, we intend to provide the agency with a complete validation protocol for our surrogate endpoint prior to submission of the new drug application," said Vicente Anido, Jr., Ph.D., ISTA's chief executive officer. "We will now begin the process of unmasking the data, conducting the statistical analysis and verifying its accuracy. We will report results once they become available."

Addressing activity in the company's stock, Dr. Anido further commented that the recent trading volume increase may have been due to the distribution of a significant number of shares to the limited partners of one of ISTA's early institutional shareholders.

Vitrase has received "fast-track" designation for the treatment of severe vitreous hemorrhage. Fast-track designation, under the FDA Modernization Act of 1997, applies to those new drugs intended for the treatment of serious or life-threatening conditions that demonstrate the potential to address an unmet medical need. Currently, the only medical treatment for vitreous hemorrhage is surgery.