Presbia, a leader in the development and marketing of a surgical solution for presbyopia, today announced its Flexivue™ micro-lens received CE certification for its products sold within the European Economic Area (EEA). Specifically, the CE mark certifies that Flexivue™ has met European Union consumer safety, health and environmental requirements.
This certification marks the completion of another significant step toward the commercialization of the Flexivue™ lens, a practical, safe, and reversible implantable alternative to reading glasses for the hundreds of millions of adults that suffer from presbyopia—the gradual loss of near vision that often affects people over the age of 40.
Zohar Loshitzer, chief executive officer of Presbia, commented, “Today’s CE certification of the Flexivue™ lens validates our technology and will enable us to move forward with commercialization of our solution for the huge presbyopic market by mid-2010.”
As part of this process, Presbia is conducting post-market surveillance of the Flexivue lens at the Institute of Vision and Optics of the University of Crete under the supervision of Professor Ioannis Pallikaris, widely regarded as the “father” of LASIK surgery and chair of the Presbia Medical Advisory Board. In addition, Prof. Pallikaris is overseeing the development of a training program for surgeons at the Institute. Presbia also anticipates two additional post-market surveillance centers to be established in Europe in the near future.
Study finds microdosing LSD leads to longer sleep: Insights from a controlled trial