Healthcare Industry News: ophthalmic viscosurgical device
News Release - January 26, 2006
Advanced Medical Optics' Tecnis(R) IOL Designated as a New Technology Intraocular Lens by the Centers for Medicare and Medicaid ServicesSANTA ANA, Calif., Jan. 26 (HSMN NewsFeed) -- Advanced Medical Optics, Inc. (AMO) (NYSE: EYE ), today announced that the Tecnis® foldable intraocular lens (IOL) has been designated as a New Technology Intraocular Lens (NTIOL) by the Centers for Medicare and Medicaid Services (CMS). The designation follows labeling claims approved by U.S. Food and Drug Administration in April 2004 that the Tecnis® foldable IOL reduced postoperative spherical aberrations compared to lenses with spherical optics and improved night driving simulator performance. The NTIOL designation goes into effect February 27, 2006 and includes both the acrylic and silicone platform Tecnis® lenses.
An NTIOL is defined as an IOL that CMS determines has been approved by the FDA for use in the labeling and advertising the IOL's claims of specific clinical advantages and superiority over existing IOLs with regard to reduced risk of intraoperative or post-operative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or other comparable clinical advantages.
In its final notice published in the Federal Register, CMS stated, "CMS approves AMO's claims of clinical advantages and superiority of the Tecnis® IOL for ocular spherical aberrations and simulated night driving. We find the AMO Tecnis® lenses models Z9000, Z9001, and ZA9003 meet the NTIOL definition and are to be given the new NTIOL classification of Reduced Spherical Aberration."
The Tecnis® IOL is the only lens approved for NTIOL reimbursement status, which provides for additional Medicare reimbursement of $50 per lens for ambulatory surgical centers, which perform more than half of all cataract surgeries in the U.S.
"Tecnis® NTIOL status confirms the unique design of the lens and the very real benefits it provides to patients," said Dr. Ralph Chu, a cataract/refractive specialist in private practice in Minneapolis and an early adopter of the Tecnis® IOL technology. "The unique modified prolate technology increases the patient's functional vision in varying light conditions, which is critical for every day tasks conducted in low-light conditions such as reading, driving at night or in the fog."
Dr. Mark Packer, clinical assistant professor of ophthalmology at the University of Oregon and clinical study investigator for several Tecnis® IOL studies, including a driving simulation study, said, "The Tecnis® lens is the only IOL available that was specifically designed, based on wavefront measurements of a representative sample of the population, to fully compensate for the spherical aberration of the cornea."
"This designation by CMS demonstrates the fact that not all aspheric lenses are created equal," said AMO President & CEO Jim Mazzo. "AMO's Tecnis® IOL is the only aspheric lens that demonstrates improved functional vision with claims approved by the FDA and NTIOL approval from CMS. These approvals underscore the unique benefits of this superior technology and validate AMO's commitment to provide truly differentiating technologies that help doctors deliver the best possible visual performance to their patients. From an industry perspective, it emphasizes the value of developing technologies that improve the quality of people's lives."
According to a November 2004 survey by ACNeilsen BASES, 88 percent of adults between the ages of 55 and 75 said they were "extremely" or "very" concerned about not being able to drive, especially at night. The study also indicated that 91 percent of adults aged 55 to 75 felt it was "extremely" or "very" important that a lens implant allows them to see in both bright and low-light situations(1).
Dr. Michael Colvard, an eye surgeon in Encino, CA with over 20 years of clinical practice and a specialty interest in IOL technology and cataract surgery added, "The Tecnis® IOL, which takes into consideration the importance of the correction of spherical aberration with cataract surgery, is one of the few truly major advances in intraocular lens technology over the past two decades."
According to an April 2004 abstract from the Archives of Ophthalmology, an estimated 20.5 million Americans older than age 40 have a cataract in either eye and the total number of persons who have a cataract is estimated to rise to 30.1 million by 2020.
About the Tecnis® foldable IOL
The Tecnis® foldable IOL is indicated for primary implantation for visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsification. The lens is intended to be placed in the capsular bag.
AMO acquired the Tecnis® foldable IOL, along with the CeeOn® IOL, Baerveldt® glaucoma shunt, and Healon® family of ophthalmic viscosurgical devices from Pfizer in June 2004.
More information is available at www.tecnisiol.com.
About Functional Vision
Youthful functional vision is the ability of the young crystalline lens to compensate for the spherical aberration of the cornea, providing quality vision. With age, the crystalline lens loses the ability to compensate for the cornea, resulting in increased spherical aberration and reduced functional vision.
Patients with reduced functional vision face many challenges that severely affect their quality of life such as walking or climbing stairs in low-light or unfamiliar settings, reading or doing work at close range, or driving at dusk, at night or in the fog.
The unique technology of the Tecnis® lens shows decreased spherical aberration and improved night driving simulator performance (in a clinical study, patients viewing a rural road through a Tecnis® lens identified a pedestrian sooner than through a traditional spherical lens). These findings suggest there is likely to be a meaningful safety benefit to elderly drivers with Tecnis® lenses, and to the drivers and pedestrians with whom they share the road. The results of the performance/ functional tests demonstrate that the Tecnis® lens improves functional vision, which in turn may improve patient safety for other life situations under low visibility conditions.
An analysis by the Potomac Institute for Policy Studies states that improved driving performance from reduced spherical aberration with the Tecnis® lens could translate into annual preventable costs of automobile accidents ranging from $450 million in 2004 up to $2.4 billion by 2014(2).
Dr. R. Bruce Wallace, III, Clinical Professor of Ophthalmology at LSU Medical School stated, "We have had a number of our Tecnis® patients comment on their enhanced vision at night and in other low light conditions, adding a margin of safety to their activities, especially for driving."
About Advanced Medical Optics
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), Clariflex®, Sensar®, CeeOn®, Tecnis® and Verisyse(TM) intraocular lenses, STAR S4 IR(TM) laser vision correction system, WaveScan Wavefront® System, CustomVue(TM) procedure, Sovereign® and Sovereign® Compact(TM) phacoemulsification systems with WhiteStar® technology, Amadeus(TM) and Amadeus(TM) II microkeratomes, Healon® viscoelastics, and the Baerveldt® glaucoma shunt. Products in the contact lens care line include disinfecting solutions, enzymatic cleaners and lens rewetting drops. Among the eye care product brands the company possesses are COMPLETE® Moisture PLUS(TM), COMPLETE® Blink-N-Clean®, Consept®F, Consept® 1 Step, Oxysept® 1 Step, UltraCare®, Ultrazyme®, Total Care(TM) 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 www.amo-inc.com.
Statements in this press release such as Dr. Chu's, Dr. Packer's, Dr. Colvard's, Dr. Wallace's and Mr. Mazzo's statements, projections by the Potomac Institute for Policy Studies, and statements regarding expected demographics and product benefits, 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, unexpected litigation, manufacturing or intellectual property issues, and the uncertainties associated with market acceptance of new products or anticipated design risks. 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 2003 Form 10-K and Form 10-Q filed November 2004 also includes information concerning these and other risk factors. Copies of press releases and additional information about AMO are available on the World Wide Web at www.amo-inc.com, or you can contact the AMO Investor Relations Department by calling 714-247-8348.
(1) Survey respondents were adults aged 55-75 years old with a valid driver's license, who drive at night at least once every few months, and who have never had cataract surgery.
(2) Potomac Institute Independent Report: Assessing the Significance of Optically Produced Reduction in Automobile Crashes in an Aging Population: Possible Economic Impacts, July 2004
TECNIS® 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. Precautions: Do not resterilize the lens; do not soak or rinse the lens with any solution other than sterile saline solution; do not store the lens in direct sunlight. Warnings: Surgeons should consider the risk/benefit ratio for adults with preoperative ocular pathology, including but not limited to inflammation, distorted eye and microbial infection. Adverse Events: Adverse events that have been documented as having occurred following intraocular lens implantation include, but are not limited to, corneal edema, iritis, lens dislocation, hyphema, macular edema and retinal detachment. For a complete listing of precautions, warnings and adverse events, refer to the package insert.
Source: Advanced Medical Optics
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