01.04.2008 10:00:00
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Advanced Medical Optics Introduces TECNIS(R) 1-Piece Intraocular Lens in U.S.
Advanced Medical Optics, Inc. (AMO) (NYSE: EYE), a global leader in
ophthalmic surgical devices and eye care products, today announced the
U.S. introduction of the TECNIS® 1-Piece intraocular lens (IOL).
The TECNIS® 1-Piece
IOL’s innovative design and ease-of-use
enhancements combine with the proven TECNIS®
IOL optics to reduce spherical aberration to essentially zero, and
improve night driving simulator performance. By targeting zero spherical
aberration, TECNIS®
lenses are designed to provide rejuvenated vision, more like that of a
younger adult with no spherical aberration.
The TECNIS® 1-Piece
IOL design combines two ground-breaking design advancements. The
innovative ProTec™
360-degree edge design has an uninterrupted barrier edge designed to
minimize cell migration onto the posterior capsule. Unlike first
generation one-piece lenses, the TECNIS®
1-Piece IOL has no interruption at the haptic-optic junction. The lens
also has a frosted edge designed to minimize edge glare. The TECNIS®
IOL Tri-Fix™ design
provides three-point fixation for exceptional stability. Refraction
stabilizes quickly after the implantation procedure.
"My expectations after 20 years for IOL performance are very high,”
said Donald R. Nixon, MD FRSC C. "The TECNIS®
1-Piece IOL has surpassed these expectations, especially for visual
outcomes and optic clarity. In addition, this new generation one-piece
design has responded to the issues associated with existing one-piece
IOLs."
Made of a hydrophobic acrylic material that blocks UV light, the TECNIS®
1-Piece IOL transmits the healthy blue light needed for improved
scotopic (dim light) vision and healthy circadian rhythms. With its
simple, one-piece design and reduced center thickness, it is easy to
implant with bag-friendly coplanar delivery and gently unfolding haptics.
AMO received approval from the Food and Drug Administration (FDA) for
the lens on October 30, 2007. The TECNIS® 1-Piece IOL received the same claims of reduced spherical
aberrations and improved night driving simulator performance as the
other IOLs in the TECNIS® portfolio.
The TECNIS® 1-Piece
IOL has been designated as a New Technology Intraocular Lens (NTIOL) by
the Centers for Medicare and Medicaid Services (CMS).
CMS recognized the TECNIS® 1-Piece
IOL (Model ZCB00) as a member of the Reduced Spherical Aberration NTIOL
subset and approved the lens for reimbursement status that 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. AMO’s TECNIS® foldable three-piece IOL was the first lens designated as an NTIOL
for reduction of spherical aberration in January 2006.
CMS can designate NTIOL status to any IOL that has been approved by the
FDA with label 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.
"The TECNIS® 1-Piece IOL marks the fifth NTIOL designation for the TECNIS®
portfolio of lenses and clearly demonstrates the technological
superiority of this platform,” said AMO
Chairman and CEO Jim Mazzo. "With this latest
NTIOL designation, CMS has further validated the distinct clinical
advantages the TECNIS®
brand of IOLs provides to surgeons and the patients they treat.”
The TECNIS® 1-Piece
IOL was launched in Europe in September 2007.
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/implant line include intraocular lenses (IOLs),
phacoemulsification systems, viscoelastics, and related products used in
ocular surgery. AMO owns or has the rights to such product brands as
ReZoom®,
Tecnis®, Clariflex®,
Sensar®, and Verisyse®
IOLs, Sovereign®,
Sovereign® Compact
and WhiteStar Signature™
phacoemulsification systems with WhiteStar®
technology, Healon®
viscoelastics, and the Baerveldt® glaucoma shunt. Products in the laser vision correction line
include wavefront diagnostic devices, femtosecond lasers and associated
patient interface devices, and excimer laser vision correction systems
and treatment cards. AMO brands in the laser vision correction business
include Star S4 IR®,
WaveScan Wavefront®,
Advanced CustomVue®,
IntraLase®
and IntraLasik®.
Products in the eye care line include dry eye drops and contact lens
disinfecting solutions, enzymatic cleaners and lens rewetting drops.
Among the eye care product brands the company possesses are COMPLETE®,
COMPLETE®
Blink-N-Clean®,
Consept®F, Consept®
1 Step, Oxysept®,
UltraCare®,
Ultrazyme®, Total
Care™ and blink™ branded products. AMO is based in Santa Ana, California, and
employs approximately 4,200 worldwide. The company has operations in 24
countries and markets products in approximately 60 countries. For more
information, visit the company's Website at www.amo-inc.com.
Forward-Looking Statements
This press release contains forward-looking statements about AMO,
including statements by Dr. Nixon and Mr. Mazzo, and statements relating
to expected product performance, trends and outcomes. 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. Copies of press releases and
additional information about AMO are available at www.amo-inc.com.
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