Advanced Medical Optics, Inc. (AMO) (NYSE:AVO), a global leader in ophthalmic surgical devices and eye care products, and OPHTEC USA, Inc., a privately held medical device manufacturer and subsidiary of OPHTEC B.V. (Netherlands), today announced an agreement to expand their strategic relationship to include the design and U.S. regulatory approval process for the Veriflex(TM) foldable phakic intraocular lens (IOL).
Under terms of the agreement, AMO and OPHTEC USA will join forces to complete design work for the Veriflex(TM), a foldable version of the Artisan(R) / Verisyse(TM) phakic IOL, which is pending FDA approval. OPHTEC is currently engaged in clinical trials in Europe on a foldable silicone phakic IOL. AMO and OPHTEC will continue to improve on the foldable lens design and develop a compatible insertion system. AMO and OPHTEC will also share responsibility for submission of the FDA Pre-Market Approval (PMA) application and implementation of human clinical trials in the United States.
Similar to its distribution rights to the Verisyse(TM) lens, AMO will be the exclusive source for the Veriflex(TM) lens in the U.S. and Japan, and also plans to market the lens in Europe and other parts of the world.
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Advanced Medical Optics and OPHTEC USA Expand Strategic Relationship to Collaborate on Veriflex Foldable Phakic IOL