Abbott Laboratories (ABT) said Wednesday that the U.S. Food and Drug Administration, or FDA, approved its Tecnis, a 1-Piece intraocular lens, or IOL, for cataract patients with or without presbyopia.
Abbott intimated that it has already commenced shipping Tecnis in select markets and intends to hit the market in full swing in April 2010.
Presbyopia is an age-related change in vision that occurs when the eye's natural lens can no longer adjust its focal length to allow clear vision at different distances.
IOLs are implanted in a patient's eye after the removal of the natural lens that has become clouded by a cataract. Tecnis, a "next-generation", easy-to-insert one-piece design, has patented wavefront-designed aspheric anterior surface designed to reduce average spherical aberration to essentially zero. It reduces chromatic aberration for better image quality.
The company informed that Tecnis lens is a pupil-independent, full diffractive presbyopia-correcting lens designed for optimal image quality at all distances under any lighting condition. Its unique optic design gives patients superior near vision and reading speed compared to other presbyopia-correcting IOLs.
Tecnis lens also received presbyopia-correcting IOL status by the Centers for Medicare and Medicaid Services. Hence, providing Medicare beneficiaries with the option to receive a Tecnis Multifocal 1-Piece lens for an additional fee as part of cataract surgery. The lenses are intended to be placed in the capsular bag.
The Abbott Park, Illinois-based company noted that conventional monofocal IOLs do not correct presbyopia, as they are designed to focus primarily at one distance.
"With this approval, Medicare cataract patients have a new opportunity to enjoy near, intermediate and distance vision without needing glasses, with nearly 9 out of 10 patients reporting that they never wear glasses following surgery. As an added benefit, surgeons now have the clinical benefits and high patient satisfaction rates they have come to expect with the TECNIS Multifocal 3-Piece IOL in a next-generation, easy to insert, one-piece design," said Jim Mazzo, senior vice president, Abbott Medical Optics.
ABT closed Tuesday's session at $54.80, on the NYSE. In the pre market session, it lost $0.30 or 0.55%.
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