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Vitrase presents new possibilities for managing vitreous hemorrhage
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DANA POINT, Calif. — Vitreous hemorrhage can be cleared after intravitreal injection with Vitrase, as shown by the results of two large, phase 3 clinical trials, said Baruch D. Kupperman, MD, PhD, here at the Sixth Annual Ocular Drug & Surgical Therapy Update Meeting.
Dr. Kupperman of the University of California - Irvine Department of Ophthalmology added the efficacy of Vitrase (sodium hyaluronidase, Ista Pharmaceuticals) was seen at one month in all trial parameters.
Current management for vitreous hemorrhage is either watchful waiting with or without surgery, Dr. Kupperman said. He went on to note that there is no drug therapy currently available to facilitate clearance.
Vitrase is a preservative-free, specially formulated and purified ovine hyaluronidase. The hyaluronidase splits the glucosaminidic bond between C1 of the glucosaminidic moiety and C4 of the glucoronic acid. This causes a temporary decrease in viscosity of cellular cement and modifies the permeability of connective tissue, Dr. Kupperman said. This liquefaction promotes diffusion of molecules and migration of cells within the vitreous. The mild inflammatory cell response then facilitates the removal of vitreous and clot debris, he added.
Current methods of treatment are “less than ideal,” Dr. Kupperman said. By just waiting, the hemorrhage often takes weeks or months to clear spontaneously and patients need frequent examinations. Often, the condition may worsen if diagnosis and treatment are delayed, Dr. Kupperman said.
Vitrectomy brings with it the potential for serious intraoperative and postoperative complications, and the procedure is associated with cataract in roughly 20% of patients who undergo the procedure, Dr. Kupperman said.
In two large, phase 3 clinical trials, Vitrase is being evaluated primarily as an agent in promoting the clearance of vitreous hemorrhage, and there is also a small study under way to evaluate the role the drug may play in the induction of posterior vitreous detachment.
The two large trials are prospective, randomized and double-masked with Vitrase vs. a saline control. The trials are being performed with men and women 18 years of age and older who present with severe vitreous hemorrhage that obscures visualization of fundus and precludes the ability to diagnose and/or treat an underlying condition. The hemorrhage must have been present for a month or longer by history or examination with patients having a best-corrected visual acuity (BCVA) worse than 20/200.
Dr. Kupperman reported that after Vitrase intravitreal injections, there was significant reduction of vitreous hemorrhage density at months 1, 2 and 3. There was a 3-line improvement in BCVA at months 1 and 2. The increase in the relative rate of BCVA improvement was 59% at 1 month and 48% at 2 months. The incidence of surrogate success evaluation was significant at both follow-up marks. The proportion of patients with an “outcome” based on monthly assessment was also significant at months 1, 2 and 3, Dr. Kupperman said.
The Sixth Annual Ocular Drug & Surgical Therapy Update Meeting is a CME activity sponsored by SLACK Incorporated and supported through an unrestricted grant from Allergan.