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Presbia receives European CE certification for presbyopia-correcting lens

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AMSTERDAM, Netherlands — Presbia, an ophthalmic device developer incorporated in 2008 through the merger of Visitome and PresbiTech, has received CE certification for its presbyopia-correcting Flexivue micro-lens, the company announced in a press release.

Measuring 3-mm in diameter and less than 20 µm in edge thickness, the hydrophilic polymer Flexivue micro-lens may be implanted in a self-sealing, stromal pocket created by a femtosecond laser, the release said.

To coincide with the approval, Presbia is currently overseeing post-market surveillance of the lens at the University of Crete's Institute of Vision and Optics. The company also expects to enlist two additional post-market surveillance centers in Europe shortly, according to the release.

"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," Zohar Loshitzer, CEO of Presbia, said in the release.

The Flexivue micro-lens and its associated implantation procedure are not available in the United States and have not received approval by the U.S. Food and Drug Administration.