For Immediate Release
JENA, December 15, 1999 – Carl Zeiss Jena GmbH, Ophthalmic Instruments Division announced today that the Swiss Regulatory Agency (Interkantonale Kontrollstelle für Heilmittel) has given approval for the marketing of VisudyneTM, under a monitored release. The Zeiss VISULASTM 690s laser in combination with Visudyne offers a new treatment for wet age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 50. The VISULAS 690s meets the requirements of the EC Medical Device Directive 93/42/EEC (CE).
Specifically, the agency approved Visudyne for the treatment of wet AMD in patients with predominantly classic subfoveal choroidal neovascularization. The commercialization of both the VISULAS 690s and Visudyne will start imminently in Switzerland.
”The approval of Visudyne by the Swiss regulatory authority and immediate availability of the VISULAS 690s laser for photodynamic therapy is a major milestone in the combined efforts of CIBA Vision® and Carl Zeiss in fighting this unfortunate disease”, said Dr. Walter-Gerhard Wrobel, Vice President & General Manager of Carl Zeiss, Ophthalmic Instruments Division. ”Using this approval to apply for a free marketing certificate will help CIBA Vision to gain approvals in a number of other markets around the world. The technology has proven its efficacy and I am positive that by using our laser, Visudyne will set the standard for treating AMD.”
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.
 Arriba
About AMD
Wet AMD typically destroys central vision, which is necessary 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.
Arriba
About Carl ZeissCarl Zeiss
has been an innovative technology leader in optics and precision engineering for more than 150 years. Carl Zeiss sets the pace in the creation of sophisticated, state-of-the-art technology dedicated to perfecting the processes of seeing and measuring. In the eye care field, Carl Zeiss is the world leader in the manufacturing of a wide variety of instruments for the use in retinal imaging, laser surgery, glaucoma management and refractive surgery.
VISULASTM 690s is a trademark of Carl Zeiss.
VisudyneTM is a trademark and CIBA Vision® is a registered trademark of Novartis AG.
Arriba
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.
Arriba |