Vitrase

IRVINE, Calif.--(BW HealthWire)--June 2, 1998--Advanced Corneal Systems, Inc. (ACS) today announced that its Registration Submission for Pharmaceutical Products for the marketing approval of Vitrase had been accepted for review by the National Ministry of Health of Mexico. Vitrase is an injectable drug designed to safely 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.

"We are very pleased to file our first regulatory submission for marketing approval for this drug which has undergone extensive evaluation by renowned clinical investigators at Conde de Valenciana Hospital and at La Ceguera Hospital in Mexico City," said Ted Danse, president and chief executive officer of ACS. "Our efforts to develop Vitrase in the United States are proceeding well, and we anticipate starting Phase III trials in the fourth quarter."

Interim results of Phase II studies of Vitrase,recently presented at the 1998 meeting of the Association for Research in Vision and Ophthalmology (ARVO) showed that the drug was well tolerated by patients. Moreover, in the majority of eyes treated, injection with Vitrase cleared the vitreous hemorrhage sufficiently within eight weeks to allow an ophthalmic surgeon to visualize the retina and treat or diagnose the cause of the hemorrhage.

Over 450,000 cases of vitreous hemorrhage occur in the United States annually from a variety of causes, but most often as a complication of diabetes. When vitreous hemorrhage occurs, light rays can no longer reach the retina of the eye and visual acuity diminishes. Additionally, the ophthalmologist often cannot see through the hemorrhage to the retina to assess its status or treat the underlying problem. Currently, most patients experiencing vitreous hemorrhage wait for the vitreous to clear on its own which can sometimes take up to 18 months. Alternatively, the patient can undergo invasive, major surgery to remove the clouded vitreous from the eye -- a procedure that can itself result in further eye damage. In contrast, Vitrase is designed to safely clear the vitreous of blood in less time than is normally required for clearing to occur on its own.

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, a non-surgical system to correct refractive vision errors.

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