Healthcare Industry News: Active Implants
News Release - January 16, 2009
Advanced Medical Optics Receives FDA Approval for TECNIS(R) Multifocal Intraocular LensDesigned To Provide Cataract Patients High-Quality Near And Distance Vision In A Range Of Light Conditions
SANTA ANA, CA, Jan. 16, 2009--(HSMN NewsFeed)--Advanced Medical Optics, Inc. (AMO) (NYSE:EYE), the global leader in advanced refractive technologies for eye care professionals and patients, today announced U.S. Food and Drug Administration (FDA) approval of the TECNIS(R) Multifocal intraocular lens (IOL) for cataract patients.
The TECNIS(R) Multifocal IOL's unique design gives patients superior near vision and reading speed compared to other presbyopia-correcting IOLs, as well as exceptionally high spectacle independence, with nearly 9 out of 10 patients reporting that they never wear glasses after surgery.
Other features/benefits include:
-- high-quality vision for near, far and intermediate distances, day or night;
-- first and only pupil-independent, non-apodized fully diffractive aspheric lens designed to correct the two highest order aberrations - spherical and chromatic - to give patients back their youthful vision;
-- 95 percent patient satisfaction - the highest of any presbyopia-correcting IOL.
"The TECNIS(R) Multifocal IOL delivers a predictable and consistent full range of vision," said Ralph Chu, M.D., founder and director of the Chu Vision Institute in Bloomington, Minn. "The U.S. clinical study shows that more than 94 percent of patients function comfortably without glasses for all distances, including intermediate. More importantly, my own patients are highly satisfied with the results."
"The full diffractive surface of the TECNIS(R) Multifocal IOL provides high-quality vision largely independent of pupil size and reduces chromatic aberration for better image quality," said Manfred Tetz, M.D., professor of ophthalmology and director of Eye-Center-Spreebogen, Berlin, Germany. "I have been implanting the TECNIS(R) Multifocal IOL since 2003 because of the high-quality visual results that I can provide for my patients, who report being extremely satisfied with their vision."
"The introduction of the TECNIS(R) Multifocal IOL in the U.S. rounds out AMO's portfolio of market-leading, refractive technologies," said AMO Chairman and CEO Jim Mazzo. "Following years of success in Europe, U.S. surgeons will soon be able to pass the benefits of this technology on to their patients."
TECNIS(R) Multifocal IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The IOLs are intended to be placed in the capsular bag.
AMO plans to ship TECNIS(R) Multifocal IOLs to U.S. surgeons in early 2009.
About Advanced Medical Optics (AMO)
AMO is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages. Products in the cataract line include monofocal intraocular lenses (IOLs), phacoemulsification systems, viscoelastics, and related products used in ocular surgery. AMO owns or has the rights to such product brands as Tecnis(R), Clariflex(R) and Sensar(R) IOLs; Sovereign(R), Sovereign(R) Compact and WhiteStar Signature(TM) phacoemulsification systems with WhiteStar(R) technology; Healon(R) viscoelastics and the Baerveldt(R) glaucoma shunt. Products in the refractive line include wavefront diagnostic devices, femtosecond lasers and associated patient interface devices; excimer laser vision correction systems and treatment cards, and refrActive Implants. AMO brands in the refractive business include iDesign(TM), iFS(TM), Star S4 IR(R), WaveScan Wavefront(R), Advanced CustomVue(TM), IntraLase(R), IntraLasik(R) and ReZoom(R), Tecnis(R) Multifocal and Verisyse(R) IOLs. Products in the eye care line include disinfecting solutions, enzymatic cleaners, lens rewetting drops and artificial tears. Among the eye care product brands the company possesses are COMPLETE(R), COMPLETE(R) Blink-N-Clean(R), Consept(R)F, Consept(R) 1 Step, Oxysept(R) 1 Step, UltraCare(R), Ultrazyme(R), Total Care(TM) and blink(R) branded products. AMO is based in Santa Ana, California, and employs approximately 3,700 worldwide. The company has operations in 27 countries and markets products in approximately 60 countries. For more information, visit the company's Website at www.amo-inc.com.
This press release contains forward-looking statements about AMO, including statements by Dr. Chu, Dr. Tetz and Mr. Mazzo, and statements relating to expected product performance and anticipated outcomes, as well as expected shipment dates. All forward-looking statements in this press release 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. 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 press releases issued by AMO and AMO's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in AMO's 2007 Form 10-K filed in March 2008 and its Form 10-Q filed in November 2008. Copies of press releases and additional information about AMO are available at www.amo-inc.com.
Source: Advanced Medical Optics
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