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Vitrase fails in studies for severe vitreous hemorrhage
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IRVINE, Calif. — Vitrase did not show a statistically significant improvement in the primary endpoint in two phase 3 trials for treatment of severe vitreous hemorrhage, according to the drug’s developer. Clinically relevant improvements in visual acuity were, however, noted in the trials, the company said.
Vitrase is an injectable form of hyaluronidase developed by Ista Pharmaceuticals. In the United States, Vitrase has received fast-track designation for the treatment of severe vitreous hemorrhage, according to Ista.
A total of 1,306 patients were enrolled in the two trials — 750 in North America and 556 in a trial outside North America. In both studies, patients with a vitreous hemorrhage for at least 1 month were enrolled if their hemorrhage was designated as severe and their best corrected-visual acuity was worse than 20/200 at the time of entry. In the North American study, patients were assigned to one of four treatment arms: saline injection, 7.5 IU, 55 IU or 75 IU Vitrase (hyaluronidase injection). The study outside North America did not have a 7.5 IU Vitrase arm.
Treatment success for the primary endpoint in both studies was defined as clearance of the vitreous hemorrhage sufficient to allow the diagnosis and appropriate treatment, if needed, of the underlying cause of the hemorrhage within 3 months following treatment. No significant difference between groups was seen for this endpoint.
However, secondary efficacy endpoints did show statistically significant, clinically relevant changes. In both studies, there was in best-corrected visual acuity (BCVA) for the 55 IU Vitrase dose . The study conducted outside North America showed a statistically significant difference for the 55 IU Vitrase dose in the time required to achieve an improvement in BCVA of 3 or more lines on an eye chart on or before 3 months following treatment compared with those receiving placebo treatment.
Additional analysis, not previously defined, showed statistically significant changes in two parameters, BCVA and vitreous hemorrhage density. Specifically, in both studies, a statistically significant improvement in BCVA was shown in the proportion of patients who had an improvement at the 1 and 2 month follow-up visits with the 55 IU dose of Vitrase. These statistically significant findings extended to the 3-month post-treatment visit in the study conducted outside North America. Statistically significant improvements in BCVA were not seen with any other doses of Vitrase at the 3-month visit. Additionally, there was a decrease in the density of the vitreous hemorrhage that was clinically meaningful and statistically significant as compared to placebo at the 1, 2 and 3-month follow up in both studies.
Adverse events included iritis, hyperemia and ocular pain; the North American study also had additional adverse events of eye irritation, increased lacrimation, reduced visual acuity, vitreous hemorrhage, photophobia and photopsia.