Advanced Medical Optics, Inc.
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(R) 1-Piece intraocular lens (IOL).
The TECNIS(R) 1-Piece IOL's innovative design and ease-of-use
enhancements combine with the proven TECNIS(R) IOL optics to reduce
spherical aberration to essentially zero, and improve night driving
simulator performance. By targeting zero spherical aberration,
TECNIS(R) lenses are designed to provide rejuvenated vision, more like
that of a younger adult with no spherical aberration.
The TECNIS(R) 1-Piece IOL design combines two ground-breaking
design advancements. The innovative ProTec(TM) 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(R) 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(R) IOL Tri-Fix(TM) 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(R) 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(R) 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(R) 1-Piece IOL received
the same claims of reduced spherical aberrations and improved night
driving simulator performance as the other IOLs in the TECNIS(R)
portfolio.
The TECNIS(R) 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(R) 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(R) 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(R) 1-Piece IOL marks the fifth NTIOL designation for
the TECNIS(R) 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(R) brand of IOLs
provides to surgeons and the patients they treat."
The TECNIS(R) 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(R), Tecnis(R), Clariflex(R), Sensar(R), and
Verisyse(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 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(R), WaveScan Wavefront(R), Advanced CustomVue(R),
IntraLase(R) and IntraLasik(R). 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(R), COMPLETE(R) Blink-N-Clean(R),
Consept(R)F, Consept(R) 1 Step, Oxysept(R), UltraCare(R),
Ultrazyme(R), Total Care(TM) and blink(TM) 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.