June 07, 2004
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AMO, Ophtec to collaborate on flexible phakic IOL

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Advanced Medical Optics and Ophtec USA will collaborate to seek U.S. regulatory approval process for the Veriflex foldable phakic IOL, according to a joint statement from the two companies.

The two companies will together complete design work on a foldable version of the Verisyse/Artisan lens, according to the joint press release. That rigid PMMA lens is already marketed in Europe by AMO as the Verisyse and by Ophtec BV as the Artisan. The PMMA lens is also awaiting U.S. regulatory approval.

Ophtec is conducting European trials on a foldable silicone phakic IOL. According to the joint press release, AMO and Ophtec will improve on the current design and develop a compatible insertion system for the lens. The two companies will share responsibility for submission of the Food and Drug Administration pre-market approval application and implementation of human clinical trials in the United States for the foldable lens.

Similar to agreements already in place, AMO will be the exclusive source for the Veriflex lens in the United States and Japan and plans to market the lens in Europe and other parts of the world, according to the press announcement.