European Union Approves Visudyne Therapy with the VISULAS 690s
For Immediate Release
JENA, August 1, 2000
The European Commission has granted approval to VisudyneTM for the treatment of wet age-related macular degeneration (AMD). The commission has followed the recommendation of a subcommittee of the European Medicines Evaluation Agency (EMEA) which proposed Markting Authorisation of Visudyne in April of this year. As the CE certificate for the VISULASTM 690s laser from Carl Zeiss was already issued back in December 1998, Photodynamic Therapy with Visudyne is now available throughout in the European Union.
”After approval was obtained for the VISULAS 690s and Visudyne in the USA in April of this year, a further milestone has now been achieved in the propagation of this new therapy,” commented Peter Amend, Product Manager for PDT at Carl Zeiss.” About 200,000 patients in the European Union lose their vision from wet AMD every year. Now there is new hope for these patients.”
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Experts estimate that 40 – 60 % of the 500,000 new cases of wet AMD all over the world will develop predominantly classical lesions as the disease progresses.
”We are delighted that, through our close collaboration with our partners CIBA Vision® and QLT, we have been able to help this innovative treatment achieve a breakthrough”, said Dr. Walter-Gerhard Wrobel, Vice President and General Manager in the Ophthalmic Instruments Division of Carl Zeiss. ”As early as June of this year, Carl Zeiss succeeded in selling an impressive total of 500 VISULAS 690s lasers and hence played its part in guaranteeing the rapid propagation of this therapy. This also makes the VISULAS 690s the world’s best selling PDT laser.”
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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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