Diabetic Vitreous Hemorrhage

April 1, 2002

Preliminary results of two phase III trials of Vitrase (hyaluronidase) did not show a statistically significant clearance of vitreous hemorrhage, the primary endpoint. However, statistically significant improvements in best-corrected visual acuity (BCVA) and vitreous hemorrhage density were demonstrated in both trials. A total of 1,306 subjects with severe vitreous hemorrhage whose visual acuity was worse than 20/200 were enrolled in the two randomized, double-masked, placebo-controlled international studies. In both trials, at one-month and two-month visits after a 55 IU Vitrase injection, statistically significant improvement in BCVA was observed. In one trial, this clinically relevant improvement extended to the three-month post-treatment visit for subjects receiving the 55 IU injection of Vitrase. In addition, significant decrease in vitreous hemorrhage density was seen at one, two, and three-month post-treatment visits. Vitrase is being developed by Ista Pharmaceuticals.