OphtecStabilEyes on FDA fast-track
This article was originally published in The Gray Sheet
Executive Summary
Opthec's capsular tension ring is granted expedited review status by FDA, announced Sept. 4. Designed to help stabilize the crystalline lens capsule during insertion of an intraocular lens, the polymethylmethacrylate (PMMA) ring-shaped device - StabilEyes - will be marketed in the U.S. by American Medical Optics, Inc. (AMO). In August, Ophtec reported it had received expedited review for its Artisan phakic intraocular lens, which also will be marketed by AMO (1"The Gray Sheet" Sept. 1, 2003, p. 3). Although no capsular tension rings have been approved by FDA, last year the agency's Ophthalmic Devices Panel reviewed and recommended approval for Morcher GmbH's capsular tension ring (2"The Gray Sheet" Jan. 21, 2002, p. 7). Following FDA approval of the Morcher product, FCI Ophthalmics will serve as its U.S. importer and distributor, a June FCI release notes...
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