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Biotech / Medical : QLT PhotoTherapeutics (QLTI) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (768)	11/24/1999 7:35:00 AM
From: Julian	Read Replies (1) \| Respond to of 1321

ZEISS VISULAS 690S LASER RECEIVES UNANIMOUS RECOMMENDATION FOR FDA APPROVAL DUBLIN, Calif., Nov 23, 1999 /PRNewswire via COMTEX/ -- Zeiss Humphrey Systems announced that the Ophthalmic Drugs Subcommittee of the U.S. Food and Drug Administration (FDA) recommended approval of Visudyne(TM) (verteporfin for injection) therapy and the use of Zeiss Visulas 690s for the activation of the Visudyne photosensitive treatment of wet age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 50. The Zeiss Visulas 690s(TM) laser activates Visudyne for the treatment of AMD. The Zeiss Visulas 690s laser was the only commercially produced laser in Phase III FDA Visudyne clinical trials. Throughout the phase III trials, the excellent performance of the Zeiss Visulas 690s proved its quality design on an extensive number of laser procedures. The panel's conclusions will be taken into consideration by the FDA as it completes its review of the New Drug Application (NDA) for Visudyne therapy, which was submitted by CIBA Vision on August 16, 1999. The FDA is expected to make a final decision regarding the approval of the Visudyne application on or before February 2, 2000. The panel and the FDA concurred that Visudyne therapy is generally safe and well-tolerated, with minimal adverse events relating to treatment. Currently, only 10 - 15% of the estimated 500,000 patients who develop wet AMD worldwide every year are eligible for existing treatments. Medical experts estimate that between 40-60% of all wet AMD cases will develop predominantly classic lesions as the disease progresses. "We are extremely encouraged by the results of the clinical trials and the recommendation from the subcommittee. This represents a significant step towards improving the lives of thousands of people around the world. We feel very proud to be a partner of CIBA Vision(R), and QLT PhotoTherapeutics in the treatment of this debilitating disease. The technology has proven its efficacy and I am positive that by using our laser, Visudyne will set the standard for treating AMD," said Lothar Koob, President of Zeiss Humphrey Systems. About AMD Wet AMD typically destroys central vision, which is essential for reading, driving, and recognizing faces. The condition is characterized by the formation of abnormal blood vessels (choroidal neovasculature or CNV) that grow across the central part of the retina, called the macula. These vessels leak fluid and eventually cause scar tissue, which destroys central vision in as little as 2 months to 3 years. About Zeiss Humphrey Systems Zeiss Humphrey Systems and its parent company, Carl Zeiss, Inc. have been in business for over 150 years. In the eye care field, Zeiss Humphrey Systems is the world leader in the manufacturing of a wide variety of instruments for use in retinal imaging, laser surgery, glaucoma management and refractive surgery management. NOTE: Visudyne(TM) is a trademark and CIBA Vision(R) is a registered trademark of Novartis AG. Zeiss Visulas 690s(TM) is a trademark of Zeiss Humphrey Systems. The foregoing information contains forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Such factors include: risks associated with the commercialization of Visudyne(TM) therapy; dependence on corporate relationships; manufacturing uncertainties; uncertainty of pricing and reimbursement; uncertainties relating to clinical trials and product development; uncertainty of competition or rapid growth; uncertainty regarding patents and proprietary rights; product liability claims and insurance; no assurance of regulatory approval or government regulation. SOURCE Zeiss Humphrey Systems (C) 1999 PR Newswire. All rights reserved. prnewswire.com -0- CONTACT: Dr. Victor Miranda, Marketing Manager, 925-557-4325, or fax, 925-557-4775, or Ms. Gina Crabb, Marketing Communications Manager, 925-557-4409, or fax, 925-557-4319, both of Zeiss Humphrey Systems GEOGRAPHY: California INDUSTRY CODE: MTC BIO