ISTA PHARMACEUTICALS ANNOUNCES PUBLICATION OF VITRASE PHASE III RESULTS

ISTA Pharmaceuticals has announced the publication of the pooled safety and efficacy findings of the company's two randomized, double-masked, placebo-controlled Phase III studies of Vitrase (ovine hyaluronidase) for the management of vitreous hemorrhage, a serious condition affecting the back of the eye for which there is currently no drug treatment.

The pooled analysis of the two Phase III clinical trials demonstrated a statistically significant reduction in vitreous hemorrhage (VH) density as early as one month that persisted through three months following a single intravitreous injection of Vitrase when compared to a single injection of saline solution. This reduction in VH density allowed the investigator to see into the back of the eye to diagnose the underlying cause of the hemorrhage and treat with laser therapy when appropriate. The results also demonstrated that the drug has a favorable safety profile, and no serious safety issues were reported following a single intravitreous injection of Vitrase.

The efficacy findings entitled, "Pooled Efficacy Results from Two Multinational Randomized Controlled Clinical Trials of a Single Intravitreous Injection of Highly Purified Ovine Hyaluronidase (Vitrase®) for the Management of Vitreous Hemorrhage," and the safety findings entitled, "Safety Results of Two Phase III Trials of an Intravitreous Injection of Highly Purified Ovine Hyaluronidase for the Management of Vitreous Hemorrhage," were published in the American Journal of Ophthalmology.