ISTA Pharmaceuticals, Inc. announced that Edgar Thomas, MD, of the Retina-Vitreous Associates Medical Group, presented integrated data from two Phase III clinical trials of Vitrase (ovine hyaluronidase) for the treatment of vitreous hemorrhage (VH) in patients with diabetes at Hawaii 2004: the Royal Hawaiian Eye Meeting. Vitreous hemorrhage is a serious condition affecting the back of the eye for which there is currently no drug treatment.
Nearly 80 per cent of the patients enrolled in two double-masked, placebo-controlled trials had a history of diabetes and approximately 90 per cent of the patients could not read any letters on a vision chart at the beginning of the study. The results from the diabetic subset analysis showed that more than twice the number of patients treated with Vitrase had a reduction in hemorrhage density compared to the control group as early as one month following a single intravitreous injection. 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. For those patients with proliferative diabetic retinopathy as the likely cause for their hemorrhage, more than twice the number of those patients treated with Vitrase were able to receive laser therapy as early as one month following a single intravitreal injection, as compared to those in the control group.
These Phase III clinical results were previously submitted to the US Food & Drug Administration as part of ISTA's New Drug Application (NDA) for Vitrase for vitreous hemorrhage and were publicly announced last year.
ISTA's Vitrase is a proprietary formulation of highly purified ovine hyaluronidase, which has been studied for administration by injection into the vitreous of the eye.