FDA Approves enVista™, a Single-Piece Intraocular Lens, Made from the Glistening-Free, Hydrophobic, Acrylic Material Developed by AVS

June 25, 2012, Osaka, Japan – Santen Pharmaceutical Co., Ltd. announced that Bausch + Lomb (Rochester, New York) received approval of enVista™, the first glistening-free, single-piece hydrophobic acrylic Intraocular Lens (“IOL”) from the U.S. Food and Drug Administration on June 20, 2012.
The enVista lens received CE Mark approval in the European Union in September 2011 and is currently pending approvals worldwide. Full commercial release of the enVista IOL in the U.S. is planned upon FDA clearance of its supporting insertion system.

About enVista IOL.
The enVista lens is manufactured using a glistening-free, foldable hydrophobic acrylic IOL material developed by Advanced Vision Science, Inc (California, “AVS”), a consolidated subsidiary of Santen. The AVS material was designed to provide excellent mechanical characteristics and clarity. The AVS material has been marketed by Santen in Japan since 2008 as the Eternity IOL.

License Agreement for AVS material.
On March 3, 2009, Advanced Vision Science and Bausch + Lomb entered into a worldwide license agreement granting Bausch + Lomb the right for the development, manufacturing and marketing of its foldable hydrophobic acrylic IOL material in all geographic regions except Japan.

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Related Topics and Keywords

enVista, single-piece hydrophobic acrylic Intraocular Lens