ISTA: model predicts treatment success with Vitrase in vitreous hemorrhage in diabetes

By Lisa Kerner

Erie, Pa., May 1 - A subset analysis of ISTA Pharmaceuticals, Inc.'s two randomized, double-masked, placebo-controlled phase 3 clinical studies of Vitrase for the treatment of vitreous hemorrhage allowed prediction of treatment success following a single intravenous injection of 55 IU or 75 IU Vitrase.

ISTA enrolled 750 patients in its North American study, assigning patients to one of four treatment arms (saline injection, 7.5 IU, 55 IU or 75 IU Vitrase injection). An additional 556 patients, treated in the second study outside North America, were assigned to one of three treatment arms (saline injection, 55 IU or 75 IU Vitrase injection).

The primary endpoint in both studies was the clearance of vitreous hemorrhage allowing for diagnosis and treatment of the underlying cause of the vitreous hemorrhage, within three months following treatment.

The Total Hemorrhage Point Score was used to measure the density of vitreous hemorrhage. Treatment success was measured by best corrected visual acuity of three or more lines on an eye chart at three months.

"The existing phase 3 data on our thimerosal-free Vitrase to manage vitreous hemorrhage, a serious and severely debilitating eye ailment, is further reinforced by this subset analysis of treatment predictors in patients with diabetes," vice president of clinical research Lisa R. Grillone said in a company news release.

"For the first time, clinicians can be provided with a tool for managing vitreous hemorrhage patient, and using this model, can predict treatment success one month post-injection."

ISTA presented the study details in two scientific poster presentations during the 2006 annual meeting of The Association for Research in Vision and Ophthalmology in Fort Lauderdale, Fla.

Vitrase is a proprietary formulation of highly purified ovine hyaluronidase.

ISTA is an Irvine, Calif., specialty pharmaceutical company specializing in ophthalmic products.

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