Zeiss VISULASTM 690s Laser Receives Approval from FDA
For Immediate Release
Jena, Germany. – April 12, 2000 – Carl Zeiss announced that the U.S. Food and Drug Administration (FDA) has approved the use of the Zeiss VISULAS 690s Laser for the activation of VisudyneTM (verteporfin for injection) therapy to treat wet age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 50. The Zeiss VISULAS 690s Laser activates Visudyne for the treatment of wet AMD, and was the ONLY commercially produced laser in Visudyne Phase III FDA clinical trials. ”We were able to enhance the lives of many AMD patients throughout the Phase III trials and now have over two years of efficacy and safety information,” noted Dr. Walter-Gerhard Wrobel, Vice President and General Manager of Carl Zeiss Jena, Ophthalmic Instruments Division. ”This is a extraordinary advance in the treatment of AMD and Carl Zeiss is proud to help bring this therapy to patients who suffer with this degenerative disease.”
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The FDA has approved Visudyne therapy specifically for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization (CNV). Carl Zeiss, a worldwide leader in ophthalmic disease management, offers a full portfolio of diagnostic and treatment solutions designed to support retina specialists and general ophthalmologists. 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. The Zeiss VISULAS 690s will contribute greatly to treating these patients based on the FDA’s approval of Visudyne therapy.
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”This approval represents a significant step towards improving the lives of thousands of people around the world. Working with our partners, CIBA Vision® and QLT PhotoTherapeutics, we will continue to innovate in the treatment of this disease. The technology has proven to be safe and effective and I am positive that by using our laser, Visudyne will set the standard for treating AMD,” comments Dr. Wrobel.
About AMD
Wet AMD typically destroys central vision, which is necessary for reading, driving, and even 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.
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About Carl Zeiss
Carl Zeiss has been in the optical business for over 150 years. As the world leader in ophthalmic disease management, Carl Zeiss Jena, Ophthalmic Instruments Division, offers a wide variety of instruments for the use in retinal imaging, laser surgery, glaucoma management and refractive surgery management. Carl Zeiss, the world leader in ophthalmic diagnostic and therapeutic instrumentation continues to demonstrate it’s commitment to the ophthalmic community with new products designed to advance the standard of eye care worldwide.
VISULASTM 690s is a trademark of Carl Zeiss.
VisudyneTM is a trademark and CIBA Vision® is a registered trademark of Novartis AG.
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Carl Zeiss Contacts:
Carl Zeiss de México S.A.de C.V.
División MED
M.A. de Quevedo, 496
Col. Sta. Catarina/Coyoacán
C.P. 04010
México D.F.
MÉXICO
Tel.: ++52. (55) 59-99-02-25
Fax: ++52 (55) 59-99-02-36
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 the VISULAS 690s; 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.
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