Healthcare Industry News:  cataract 

Devices Ophthalmology Regulatory

 News Release - June 23, 2006

Visiogen Inc. Receives European CE Mark for Its Dual-Optic Accommodating Intraocular Lens

IRVINE, Calif.--(HSMN NewsFeed)--June 23, 2006--Visiogen Inc. of Irvine today announced that it has received approval in Europe for its dual-optic accommodating intraocular lens (AIOL). The CE Mark designation for the Visiogen SynchronyŽ AIOL signifies that the device conforms to the essential requirements of the Medical Devices Directive (MDD), and further validates the viability of the product.

"Having a CE Mark allows us to expand into post-marketing research studies within Europe to further build the scientific foundation for Synchrony," said Reza Zadno, Ph.D., Visiogen's president and CEO. "As a result of this milestone, our product has moved beyond the early investigational stages, and has been validated as a commercially viable product by an international regulatory body."

Visiogen's Synchrony AIOL is the first dual-optic accommodating lens developed for both cataract and refractive surgery. It is designed to enable accommodation in patients undergoing cataract surgery who may or may not have a presbyopic condition. Presbyopia is a visual condition that results in the inability to focus near, which makes reading without glasses nearly impossible. The condition affects nearly all people by the age of 50. The unique dual-optic design of Synchrony can provide vision at all distances, without the optical limitations from multifocality.

The Synchrony system incorporates the dual-optic lens, with a proprietary easy-to-use pre-loaded injector. The entire system is self-contained and ready for use without the need for lens handling. The dual-optic lens can be inserted through a 3.6-3.8 mm clear-corneal incision. The single-piece silicone lens unfolds in the eye upon insertion and features two optics connected by a spring system. The springs connect a 5.5 mm high-power anterior optic and a 6 mm negative power posterior optic; the spring action moves the front optic and changes the eye's focus from near to far. This unique combination of positive and negative powered optics is customized for each individual patient.

"My patients are very satisfied with the lens and the outcomes. Most of them are able to read without glasses and can comfortably see distant images," said H. Burkhard Dick, M.D., professor and chairman of the University Eye Hospital of Bochum, Germany. Dick has implanted over 20 Synchrony lenses in clinical study patients. "My overall impression of the safety and effectiveness of Synchrony is extremely good."

Worldwide, the Synchrony dual-optic accommodating lens has been implanted in over 300 subjects, in seven countries and at multiple clinical sites over the past four years. Currently, an FDA clinical study for Synchrony is being conducted in the United States.

About Visiogen

Visiogen Inc. is focused on developing innovative products for cataract and refractive patients. Founded in Irvine in 2001, Visiogen's first commercial application, SynchronyŽ, a dual-optic accommodating intraocular lens and pre-loaded injector, is currently in clinical studies in the U.S. and recently received a CE Mark in Europe.


Source: Visiogen

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