Advanced Medical
Optics, Inc today announced that the US Food & Drug
Administration (FDA) has approved the TECNIS(R) intraocular lens (IOL) on an
acrylic platform.
The TECNIS(R) foldable acrylic IOL offers surgeons and their patients the
same unique benefits as the TECNIS(R) silicone IOL. AMO is the only company
to market IOLs with a claim approved by the FDA for reduced spherical
aberration and improved functional vision.
"FDA approval of the TECNIS(R) acrylic IOL marks an important milestone
for AMO because it represents the first approved product that combines the
outstanding optical technology from our 2004 acquisition of the Pfizer
ophthalmic surgical business, with our existing advanced IOL materials
expertise," said AMO President and CEO Jim Mazzo. "This FDA approval broadens
our portfolio of acrylic IOLs, providing more options for our customers and
their patients."
Visual performance degrades with age, including a loss of functional
vision, which is caused by an increase in the optical aberration of the eye
that may result in difficulty seeing in low light conditions. Cataract
patients with reduced functional vision may be challenged driving at dusk or
at night, experience trouble reading or doing work at close range, or lack
confidence navigating stairs or unfamiliar settings. The TECNIS(R) lens
reduces spherical aberration and improves functional vision in varying light
conditions, which is likely to provide a meaningful safety benefit for older
drivers and pedestrians with whom they share the road.
In a simulated night driving study, patients viewing a rural road through
the TECNIS(R) lens identified a pedestrian hazard significantly sooner than
through a traditional spherical IOL. The TECNIS(R) lens also provided a
45-foot advantage in detection and identification distance. At 55 MPH, this
would provide an additional 0.5 seconds to perceive and react to a pedestrian
hazard.
AMO plans to release the TECNIS(R) foldable acrylic IOL commercially in
the U.S. and Europe in September 2005.
About the TECNIS(R) IOL
The eyes, like other parts of the body, actually fall out of balance with
age. The cornea and natural crystalline lens of a young person work together
to focus light onto the retina. Over time, the natural lens loses some of its
ability to balance the cornea, resulting in vision that is not quite as crisp
as it used to be.
Typical cataract surgery restores cornea/lens balance to a
level equivalent to that of a healthy older person. The TECNIS(R) lens
implant restores the cornea/lens balance to a level more like that of a
healthy younger person. While most IOLs are made with a spherical (rounded)
surface, the TECNIS(R) lens is an aspheric wavefront-designed optic.
This
design was developed by collecting actual wavefront measurements from human
corneas of a representative sample of the population. Then, a modified
prolate intraocular lens surface was created that reduces spherical aberration
and works with the cornea in a way that more closely resembles the balance of
a natural lens and cornea of a young person. The result is improved
functional vision for most people after cataract surgery.
TECNIS(R) 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. For a complete listing of
precautions, warnings and adverse events, refer to the package insert.
About Advanced Medical Optics (AMO)
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), Phacoflex(R), Clariflex(R), Array(R),
Sensar(R), CeeOn(R), Tecnis(R) and Verisyse(TM) intraocular lenses, STAR S4
IR(TM) laser vision correction system, WaveScan Wavefront(R) System,
CustomVue(TM) procedure, Sovereign(R) and Sovereign(R) Compact(TM)
phacoemulsification systems with WhiteStar(TM) technology, Amadeus(TM) and
Amadeus(TM) II microkeratomes, Healon(R) and Vitrax(R) viscoelastics, and the
Baerveldt(R) glaucoma shunt. Products in the contact lens care line include
disinfecting solutions, daily cleaners, enzymatic cleaners and lens rewetting
drops. Among the contact lens care product brands the company possesses are
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), Total
Care(R) 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 amo-inc.
Forward-Looking Statements
Mr. Mazzo's statements and statements in this press release regarding new
product benefits and expected release timing, 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, AMO's ability to obtain adequate product
supply, unexpected litigation or intellectual property issues, and the
uncertainties associated with market acceptance of new products. 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 2004 Form 10-K filed in March 2005 include information
concerning these and other risk factors. Copies of press releases and
additional information about AMO are available at amo-inc, or you can
contact the AMO Investor Relations Department by calling 714-247-8348.
Advanced Medical Optics, Inc.
Investors:
Sheree Aronson
(714) 247-8290
sheree.aronsonamo-inc
Media:
Steve Chesterman
(714) 247-8711
steve.chestermanamo-inc
Advanced Medical Optics, Inc.
amo-inc
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