FDA approves TECNIS(R) foldable acrylic intraocular lens
Aug 10, 2005 - 8:33:00 PM, Reviewed by: Dr.
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The TECNIS(R) lens reduces spherical aberration and improves functional vision in varying light conditions, which is likely to provide a meaningful safety benefit for older drivers and pedestrians with whom they share the road.
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By Advanced Medical Optics, Inc.,
Advanced Medical Optics, Inc. (AMO) , today announced that the U.S. Food & Drug Administration (FDA) has approved the TECNIS(R) intraocular lens (IOL) on an acrylic platform.
The TECNIS(R) foldable acrylic IOL offers surgeons and their patients the same unique benefits as the TECNIS(R) silicone IOL. AMO is the only company to market IOLs with a claim approved by the FDA for reduced spherical aberration and improved functional vision.
"FDA approval of the TECNIS(R) acrylic IOL marks an important milestone for AMO because it represents the first approved product that combines the outstanding optical technology from our 2004 acquisition of the Pfizer ophthalmic surgical business, with our existing advanced IOL materials expertise," said AMO President and CEO Jim Mazzo. "This FDA approval broadens our portfolio of acrylic IOLs, providing more options for our customers and their patients."
Visual performance degrades with age, including a loss of functional vision, which is caused by an increase in the optical aberration of the eye that may result in difficulty seeing in low light conditions. Cataract patients with reduced functional vision may be challenged driving at dusk or at night, experience trouble reading or doing work at close range, or lack confidence navigating stairs or unfamiliar settings. The TECNIS(R) lens reduces spherical aberration and improves functional vision in varying light conditions, which is likely to provide a meaningful safety benefit for older drivers and pedestrians with whom they share the road.
In a simulated night driving study, patients viewing a rural road through the TECNIS(R) lens identified a pedestrian hazard significantly sooner than through a traditional spherical IOL. The TECNIS(R) lens also provided a 45-foot advantage in detection and identification distance. At 55 MPH, this would provide an additional 0.5 seconds to perceive and react to a pedestrian hazard.
AMO plans to release the TECNIS(R) foldable acrylic IOL commercially in the U.S. and Europe in September 2005.
About the TECNIS(R) IOL
The eyes, like other parts of the body, actually fall out of balance with age. The cornea and natural crystalline lens of a young person work together to focus light onto the retina. Over time, the natural lens loses some of its ability to balance the cornea, resulting in vision that is not quite as crisp as it used to be. Typical cataract surgery restores cornea/lens balance to a level equivalent to that of a healthy older person. The TECNIS(R) lens implant restores the cornea/lens balance to a level more like that of a healthy younger person. While most IOLs are made with a spherical (rounded) surface, the TECNIS(R) lens is an aspheric wavefront-designed optic. This design was developed by collecting actual wavefront measurements from human corneas of a representative sample of the population. Then, a modified prolate intraocular lens surface was created that reduces spherical aberration and works with the cornea in a way that more closely resembles the balance of a natural lens and cornea of a young person. The result is improved functional vision for most people after cataract surgery.
TECNIS(R) foldable intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsification. The lenses are intended to be placed in the capsular bag. Rx Only. For a complete listing of precautions, warnings and adverse events, refer to the package insert. 
- United States Food and Drug Administration
www.amo-inc.com
About Advanced Medical Optics (AMO)
AMO is a global medical device leader focused on the discovery and delivery of innovative vision technologies that optimize the quality of life for people of all ages. Products in the ophthalmic surgical line include intraocular lenses, laser vision correction systems, phacoemulsification systems, viscoelastics, microkeratomes and related products used in cataract and refractive surgery. AMO owns or has the rights to such ophthalmic surgical product brands as ReZoom(TM), Phacoflex(R), Clariflex(R), Array(R), Sensar(R), CeeOn(R), Tecnis(R) and Verisyse(TM) intraocular lenses, STAR S4 IR(TM) laser vision correction system, WaveScan Wavefront(R) System, CustomVue(TM) procedure, Sovereign(R) and Sovereign(R) Compact(TM) phacoemulsification systems with WhiteStar(TM) technology, Amadeus(TM) and Amadeus(TM) II microkeratomes, Healon(R) and Vitrax(R) viscoelastics, and the Baerveldt(R) glaucoma shunt. Products in the contact lens care line include disinfecting solutions, daily cleaners, enzymatic cleaners and lens rewetting drops. Among the contact lens care product brands the company possesses are COMPLETE(R) Moisture PLUS(TM), COMPLETE(R) Blink-N-Clean(R), Consept(R)F, Consept(R) 1 Step, Oxysept(R) 1 Step, UltraCare(R), Ultrazyme(R), Total Care(R) and blink(TM) branded products. Amadeus is a licensed product of, and a trademark of, SIS, Ltd. AMO is based in Santa Ana, California, and employs approximately 3,500 worldwide. The company has operations in 24 countries and markets products in approximately 60 countries. For more information, visit the company's Web site at http://www.amo-inc.com/.
Forward-Looking Statements
Mr. Mazzo's statements and statements in this press release regarding new product benefits and expected release timing, and any other statements that refer to AMO's estimated or anticipated future results are forward-looking statements. All forward-looking statements in this press release reflect AMO's current analysis of existing trends and information and represent AMO's judgment only as of the date of this press release. Actual results may differ from current expectations based on a number of factors affecting AMO's businesses, including but not limited to unexpected changes in competitive, regulatory and market conditions, AMO's ability to obtain adequate product supply, unexpected litigation or intellectual property issues, and the uncertainties associated with market acceptance of new products. Therefore, the reader is cautioned not to rely on these forward-looking statements. AMO disclaims any intent or obligation to update these forward-looking statements.
Additional information concerning these and other risk factors may be found in previous financial press releases issued by AMO. AMO's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Certain Factors and Trends Affecting AMO and its Businesses" in AMO's 2004 Form 10-K filed in March 2005 include information concerning these and other risk factors. Copies of press releases and additional information about AMO are available at http://www.amo-inc.com/, or you can contact the AMO Investor Relations Department by calling 714-247-8348.
Advanced Medical Optics, Inc. Investors: Sheree Aronson (714) 247-8290 [email protected] Media: Steve Chesterman (714) 247-8711 [email protected]
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