Vitrase

IRVINE, Calif.--(BW HealthWire)--Oct. 15, 1998--Advanced Corneal Systems, Inc. (ACS) today announced that the company's investigational drug Vitrase(tm), a product for treatment of vitreous hemorrhage or bleeding into the back portion of the eye, has been designated a "Fast Track" product by the United States Food and Drug Administration (FDA).

Under the FDA Modernization Act of 1997, the FDA can designate a product as "Fast Track" if it is intended for the treatment of a serious or life-threatening condition, and it demonstrates the potential to address unmet medical needs for such a condition. This designation means that the FDA will facilitate the development and expedite the review of Vitrase.

"We are very pleased that the FDA has agreed to expedite its consideration of Vitrase as a treatment for vitreous hemorrhage," said Ted Danse, president and chief executive officer of ACS. "Receiving this Fast Track designation underscores the potential importance of Vitrase to address a serious medical problem that often results as a complication of diabetes and other ophthalmic conditions for which current treatments are lacking or inadequate."

ACS is currently completing a Phase II clinical trial of Vitrase in the United States and expects to initiate multinational Phase III clinical studies by year-end.

Vitreous hemorrhage clouds the sight of affected individuals and makes it difficult for the ophthalmologist to assess the retina adequately to treat the underlying problem. 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.

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 clear vitreous hemorrhage, and Corneaplasty(tm), a non-surgical system to correct refractive errors.

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