IRVINE, Calif.--(BW HealthWire)--Nov. 23, 1998--Advanced Corneal Systems, Inc. (ACS) today announced today that the company has initiated a Phase III multi-site study of its investigational drug, Vitrase(tm), in the United States.
Vitrase is an injectable drug designed to induce the clearing of vitreous hemorrhage, or bleeding into the back portion of the eye, in less time than is normally required for clearing to occur on its own so that the ophthalmologist can treat the underlying problem.
The randomized, double-masked study will enroll 800 patients in four study groups. Three of the groups will each receive one of three different doses of Vitrase (7.5 international units (IU), 55 IU, and 75 IU) in a single 50 microliter intravitreal injection.
The fourth patient group will be observed according to the current standard medical practice of "watchful waiting" for the vitreous hemorrhage to clear on its own. Patients will be evaluated for three months post enrollment for efficacy of the Vitrase treatment, and for 12 months for safety.
The endpoint for determining the efficacy of the Vitrase treatment will be successful treatment of the underlying causes of vitreous hemorrhage.
"Vitreous hemorrhage is a serious problem for those affected because it not only affects the patient's visual acuity, but can prevent the ophthalmologist from evaluating and treating the underlying cause of the hemorrhage," said David Harper, M.D., medical director at ACS. "Based on our clinical experiences to date, Vitrase offers the potential to be the first non-surgical treatment for vitreous hemorrhage."
Results of a previous Phase III study of Vitrase conducted outside of the United States showed a significant difference in the incidence of vitreous hemorrhage clearance for patients with dense hemorrhages, with the highest proportion of dense hemorrhage clearance occurring in the 75 IU dose.
Treatment was well tolerated at all dose levels, and no serious, unexpected treatment-related adverse events were reported.
Pioneering development of Vitrase was conducted by scientists at Cedars Sinai Ophthalmology Research Labs who were investigating the impact of various enzymes in the vitreous. Since that time, ACS has undertaken the clinical development of Vitrase, and in early October received "Fast Track" designation from the U.S. Food and Drug Administration for use as a treatment for vitreous hemorrhage.
Vitreous hemorrhage clouds the sight of affected individuals and makes it difficult for the ophthalmologist to adequately assess the retina to treat the underlying problem. Over 450,000 cases of vitreous hemorrhage occur in the United States annually due to a variety of causes, but most often as a complication of diabetes.
Advanced Corneal Systems, Inc. is a privately held company founded in 1992 to discover, develop and commercialize proprietary therapeutic systems for the treatment of visual disorders.
The company is currently conducting domestic and international clinical trials on both Vitrase, a drug designed to rapidly clear vitreous hemorrhage, and Corneaplasty(tm), a non-surgical system to correct refractive vision errors.
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