Vitrase may sufficiently reduce density of vitreous hemorrhage

MADRID, Spain — Vitrase was shown to slow hemorrhage sufficiently to diagnose and treat vitreous hemorrhage, Marc de Smet, MD, said here during the Congress of the European Society of Ophthalmology. Dr. Smet is a clinical investigator for Ista Pharmaceutical’s ovine hyaluronidase product.

The randomized, multicenter phase 3 study included 556 patients equally divided among three treatment groups: Vitrase 55 IU, Vitrase IU and control. Inclusion parameters included vitreous hemorrhage for at least 1 month, visual acuity of 20/200 or worse and no history or presence of retinal detachment, tear or break, Dr. de Smet said. About 70% of patients were diabetic, with the majority having proliferative diabetic retinopathy. The other patients had some retinal vein occlusion and age-related macular degeneration.

Key endpoints included reduction of the vitreous hemorrhage (from grade 3 or 4 to grade 1 or 0) and improvement of best corrected visual acuity (BCVA), defined as a minimal 3 line gain.

Patients receiving Vitrase 55 IU showed a statistically significant improvement as early as month 1. Almost 20% of the patients in this group had a reduction in hemorrhage compared with 11% in the control group. At month 3, 36% of patients in the Vitrase 55 IU group showed a reduction in hemorrhage compared with 25% of the control group. This is clinically relevant to allowing earlier treatment and diagnosis of the patients, and also a statically significant improvement in BCVA was observed, Dr. de Smet said.

Reduction in hemorrhage was clinically significant but not statistically significant for patients receiving Vitrase 75 IU.

Adverse reactions included iritis, hyperemia and eye pain, almost all of which resolved in one month, Dr. de Smet said.