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Vitreous hemorrhage drug Vitrase moves into phase 3 trials
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IRVINE, Calif. — Ista Pharmaceuticals Inc. (NASDAQ: ISTA) has completed patient enrollment in one of two phase 3 clinical trials for Vitrase (injectable hyaluronidase) for the treatment of severe vitreous hemorrhage.
Company executives report 680 patients have been enrolled at sites in the United States, Mexico and Canada. Ista is also conducting additional phase 3 studies outside North America. Vitrase has received fast track designation from the FDA for the treatment of vitreous hemorrhage. According to company executives, about 450,000 cases of vitreous hemorrhage occur each year; of those, about half would be candidates for Vitrase treatment.
Worldwide, 1,190 patients are targeted for enrollment in the prospective, double-masked, randomized, placebo-controlled phase 3 clinical trials. Patients with a vitreous hemorrhage for more than 1 month are eligible if the vitreous hemorrhage is severe and the patient’s best corrected visual acuity is worse than 20/200 at the time of entry into the study. Safety and efficacy assessments are made during regularly scheduled visits, with efficacy determined during the 90-day period following treatment. Preliminary results for the studies are expected to be available in the fourth quarter of 2001.
Ista is also conducting a separate pilot phase 2 clinical trial to evaluate the use of Vitrase for the treatment of diabetic retinopathy. In 2000, Ista entered into a commercial partnership with Allergan for the marketing, sale and distribution of Vitrase in the United States and all international markets except Mexico before 2004, and Japan.