Randomized, Controlled, Double-Masked Clinical Trial of Synchrony(R) Accommodating IOL Demonstrates Positive Impact of True Accommodation on Patient O

IRVINE, Calif.--(BUSINESS WIRE)--Visiogen, Inc. was well represented at the XXVI Congress of the European Society of Cataract and Refractive Surgeons (ESCRS), held in Berlin from September 13 to 17. Six independent investigators presented clinical results at the meeting, confirming that the physiologic design and proven accommodation mechanism of the Synchrony® IOL is providing patients with sustained positive outcomes and functional vision at all distances.

The Synchrony accommodating IOL, currently in the final stages of the U.S. investigational device exemption (IDE) trial, is also being studied in multiple randomized, controlled, double-masked clinical trials around the world-- a level and quality of clinical evidence that is matched by few other commercially-available premium intraocular lenses. Results from a long-term randomized multicenter trial in Colombia comparing Synchrony to the ReSTOR multifocal IOL were presented at ESCRS, demonstrating equivalent vision to ReSTOR at distance and near, and significantly better intermediate vision for patients implanted with Synchrony. The lens also showed significantly less incidence of moderate to severe halos and glare, and better quality of vision as measured by contrast sensitivity. These data were reported at six months after binocular implantation. Additionally, a second study evaluated long term outcomes in patients implanted with Synchrony. This study demonstrated extremely low posterior capsule opacification (PCO) formation, with a posterior capsulotomy YAG rate of only 4.3% at two years.

“We continue to be impressed with the visual outcomes being provided by the Synchrony lens. We now have data on patients two years post-implantation and the results we are seeing indicate that the vast majority of these patients are getting a full range of vision without night time dysphotopsias. We are also impressed with the extremely low PCO rates, which are likely a result of the unique physiologic design of the lens which preserves of three-dimensional capsular geometry,” said Ivan L. Ossma, M.D., M.P.H., a leading clinical investigator of the Synchrony lens.

“There is continued scientific interest in the Synchrony technology as evidenced by the amount of attention we received at ESCRS. Many in the industry are awaiting the ‘next generation’ lens that will offer patients true accommodation. Synchrony is poised to be the first truly accommodating lens because of its intuitive physiologic design and demonstrated accommodation mechanism. Additionally, it is the only lens that preserves physiologic capsular geometry, facilitating aqueous flow within the capsule,” said Reza Zadno, President and CEO of Visiogen, Inc.

A complete bibliography of publications and presentations on the Synchrony accommodating intraocular lens is available at www.visiogen.com.

About Visiogen

Visiogen, Inc. is focused on developing innovative products for cataract and refractive patients. Founded in Irvine, California, in 2001, Visiogen’s first commercial application, Synchrony®, a 3-dimensional dual optic accommodating intraocular lens and pre-loaded injector, is currently in the final phase of a U.S. IDE study, and has received the CE Mark in Europe. More information about Visiogen and the Synchrony technology can be found at www.visiogen.com.

Kate Jennings
Maricich Brand Communications for Visiogen, Inc.
Tel. 949-223-6455
Fax 949-223-6451
kate@maricich.com
or
Kevin Hykes
Chief Commercial Officer
Visiogen, Inc.
info@visiogen.com