New Technology IntraocularLens (NTIOL)
via PRNewswire
SANTA ANA, Calif., Jan. 26 /PRNewswire-FirstCall/ -- Advanced MedicalOptics, Inc. (AMO) (NYSE: EYE), today announced that the Tecnis(R) foldableintraocular lens (IOL) has been designated as a New Technology IntraocularLens (NTIOL) by the Centers for Medicare and Medicaid Services (CMS). Thedesignation follows labeling claims approved by U.S. Food and DrugAdministration in April 2004 that the Tecnis(R) foldable IOL reducedpostoperative spherical aberrations compared to lenses with spherical opticsand improved night driving simulator performance. The NTIOL designation goesinto effect February 27, 2006 and includes both the acrylic and siliconeplatform Tecnis(R) lenses.
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An NTIOL is defined as an IOL that CMS determines has been approved by theFDA for use in the labeling and advertising the IOL's claims of specificclinical advantages and superiority over existing IOLs with regard to reducedrisk of intraoperative or post-operative complication or trauma, acceleratedpostoperative recovery, reduced induced astigmatism, improved postoperativevisual acuity, more stable postoperative vision, or other comparable clinicaladvantages.
In its final notice published in the Federal Register, CMS stated, "CMSapproves AMO's claims of clinical advantages and superiority of the Tecnis(R)IOL for ocular spherical aberrations and simulated night driving. We find theAMO Tecnis(R) lenses models Z9000, Z9001, and ZA9003 meet the NTIOL definitionand are to be given the new NTIOL classification of Reduced SphericalAberration."
The Tecnis(R) IOL is the only lens approved for NTIOL reimbursementstatus, which provides for additional Medicare reimbursement of $50 per lensfor ambulatory surgical centers, which perform more than half of all cataractsurgeries in the U.S.
"Tecnis(R) NTIOL status confirms the unique design of the lens and thevery real benefits it provides to patients," said Dr. Ralph Chu , acataract/refractive specialist in private practice in Minneapolis and an earlyadopter of the Tecnis(R) IOL technology. "The unique modified prolatetechnology increases the patient's functional vision in varying lightconditions, which is critical for every day tasks conducted in low-lightconditions such as reading, driving at night or in the fog."
Dr. Mark Packer , clinical assistant professor of ophthalmology at theUniversity of Oregon and clinical study investigator for several Tecnis(R) IOLstudies, including a driving simulation study, said, "The Tecnis(R) lens isthe only IOL available that was specifically designed, based on wavefrontmeasurements of a representative sample of the population, to fully compensatefor the spherical aberration of the cornea."
"This designation by CMS demonstrates the fact that not all asphericlenses are created equal," said AMO President & CEO Jim Mazzo . "AMO'sTecnis(R) IOL is the only aspheric lens that demonstrates improved functionalvision with claims approved by the FDA and NTIOL approval from CMS. Theseapprovals underscore the unique benefits of this superior technology andvalidate AMO's commitment to provide truly differentiating technologies thathelp doctors deliver the best possible visual performance to their patients.From an industry perspective, it emphasizes the value of developingtechnologies that improve the quality of people's lives."
According to a November 2004 survey by ACNeilsen BASES, 88 percent ofadults 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 alsoindicated 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 andlow-light situations(1).
Dr. Michael Colvard , an eye surgeon in Encino, CA with over 20 years ofclinical practice and a specialty interest in IOL technology and cataractsurgery added, "The Tecnis(R) IOL, which takes into consideration theimportance of the correction of spherical aberration with cataract surgery, isone of the few truly major advances in intraocular lens technology over thepast two decades."
According to an April 2004 abstract from the Archives of Ophthalmology, anestimated 20.5 million Americans older than age 40 have a cataract in eithereye and the total number of persons who have a cataract is estimated to riseto 30.1 million by 2020.
About the Tecnis(R) foldable IOL
The Tecnis(R) foldable IOL is indicated for primary implantation forvisual correction of aphakia in adults in whom a cataractous lens has beenremoved by phacoemulsification. The lens is intended to be placed in thecapsular bag.
AMO acquired the Tecnis(R) foldable IOL, along with the CeeOn(R) IOL,Baerveldt(R) glaucoma shunt, and Healon(R) family of ophthalmic viscosurgicaldevices 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 tocompensate for the spherical aberration of the cornea, providing qualityvision. With age, the crystalline lens loses the ability to compensate forthe cornea, resulting in increased spherical aberration and reduced functionalvision.
Patients with reduced functional vision face many challenges that severelyaffect their quality of life such as walking or climbing stairs in low-lightor unfamiliar settings, reading or doing work at close range, or driving atdusk, at night or in the fog.
The unique technology of the Tecnis(R) lens shows decreased sphericalaberration and improved night driving simulator performance (in a clinicalstudy, patients viewing a rural road through a Tecnis(R) lens identified apedestrian sooner than through a traditional spherical lens). These findingssuggest there is likely to be a meaningful safety benefit to elderly driverswith Tecnis(R) lenses, and to the drivers and pedestrians with whom they sharethe road. The results of the performance/ functional tests demonstrate thatthe Tecnis(R) lens improves functional vision, which in turn may improvepatient safety for other life situations under low visibility conditions.
An analysis by the Potomac Institute for Policy Studies states thatimproved driving performance from reduced spherical aberration with theTecnis(R) lens could translate into annual preventable costs of automobileaccidents ranging from $450 million in 2004 up to $2.4 billion by 2014(2).
Dr. R. Bruce Wallace , III, Clinical Professor of Ophthalmology at LSUMedical School stated, "We have had a number of our Tecnis(R) patients commenton their enhanced vision at night and in other low light conditions, adding amargin of safety to their activities, especially for driving."
About Advanced Medical Optics
AMO is a global medical device leader focused on the discovery anddelivery of innovative vision technologies that optimize the quality of lifefor people of all ages. Products in the ophthalmic surgical line includeintraocular lenses, laser vision correction systems, phacoemulsificationsystems, viscoelastics, microkeratomes and related products used in cataractand refractive surgery. AMO owns or has the rights to such ophthalmicsurgical product brands as ReZoom(TM), Clariflex(R), Sensar(R), CeeOn(R),Tecnis(R) and Verisyse(TM) intraocular lenses, STAR S4 IR(TM) laser visioncorrection system, WaveScan Wavefront(R) System, CustomVue(TM) procedure,Sovereign(R) and Sovereign(R) Compact(TM) phacoemulsification systems withWhiteStar(R) technology, Amadeus(TM) and Amadeus(TM) II microkeratomes,Healon(R) viscoelastics, and the Baerveldt(R) glaucoma shunt. Products in thecontact lens care line include disinfecting solutions, enzymatic cleaners andlens rewetting drops. Among the eye care product brands the company possessesare 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), TotalCare(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, andemploys approximately 3,500 worldwide. The company has operations in 24countries and markets products in approximately 60 countries. For moreinformation, visit the company's Web site at www.amo-inc.com.
Forward-Looking Statements
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 thePotomac Institute for Policy Studies, and statements regarding expecteddemographics and product benefits, and any other statements that refer toAMO's estimated or anticipated future results are forward-looking statements.All forward-looking statements in this press release reflect AMO's currentanalysis of existing trends and information and represent AMO's judgment onlyas of the date of this press release. Actual results may differ from currentexpectations based on a number of factors affecting AMO's businesses,including but not limited to unexpected changes in competitive, regulatory andmarket conditions, unexpected litigation, manufacturing or intellectualproperty issues, and the uncertainties associated with market acceptance ofnew products or anticipated design risks. Therefore, the reader is cautionednot to rely on these forward-looking statements. AMO disclaims any intent orobligation to update these forward-looking statements. Additional informationconcerning these and other risk factors may be found in previous financialpress releases issued by AMO. AMO's public periodic filings with theSecurities and Exchange Commission, including the discussion under the heading"Certain Factors and Trends Affecting AMO and its Businesses" in AMO's 2003Form 10-K and Form 10-Q filed November 2004 also includes informationconcerning these and other risk factors. Copies of press releases andadditional information about AMO are available on the World Wide Web atwww.amo-inc.com, or you can contact the AMO Investor Relations Department bycalling 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 implantationfor the visual correction of aphakia in adults in whom a cataractous lens hasbeen removed by phacoemulsification. The lenses are intended to be placed inthe capsular bag. Rx Only. Precautions: Do not resterilize the lens; do notsoak or rinse the lens with any solution other than sterile saline solution;do not store the lens in direct sunlight. Warnings: Surgeons should considerthe risk/benefit ratio for adults with preoperative ocular pathology,including but not limited to inflammation, distorted eye and microbialinfection. Adverse Events: Adverse events that have been documented as havingoccurred following intraocular lens implantation include, but are not limitedto, corneal edema, iritis, lens dislocation, hyphema, macular edema andretinal detachment. For a complete listing of precautions, warnings andadverse events, refer to the package insert.
Advanced Medical Optics, Inc. Investors: Sheree Aronson (714) 247-8290 sheree.aronson@amo-inc.com Media: Steve Chesterman (714) 247-8711 steve.chesterman@amo-inc.com SOURCE Advanced Medical Optics, Inc.
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