Latest News. NASA Approves Advanced LASIK for use on Astronauts
AMO's Advanced CustomVue™ LASIK with the IntraLase® Method Proves Ready for the Rigors of Space Travel
SANTA ANA, Calif. Sept. 21, 2007 / PRNewswire / – Advanced
Medical Optics, Inc. (AMO) (NYSE: EYE), a global
leader in ophthalmic surgical devices and eye care
products, today announced that the National Aeronautics
and Space Agency (NASA) has approved the company's
LASIK technologies for use on U.S. astronauts. The
NASA decision was made following review of extensive
military clinical data using AMO's Advanced CustomVue™ LASIK
with the IntraLase® Method, which showed the
combination of technologies provides superior safety
and vision.
Approved for use on consumers almost a decade ago,
more than 11 million LASIK procedures have been performed
to-date, making it the most-common elective surgical
procedure in the U.S. But it wasn't until LASIK developed
into an all-laser procedure that NASA approved it
for use on pilots, mission and payload specialists
who face extreme, physically demanding conditions
in space. The all-laser LASIK technologies, which
utilize wavefront guided and femtosecond lasers,
have also been cleared for U.S. military personnel,
including most recently Air Force pilots.
"NASA's approval is further evidence that today's
LASIK exceeds all established standards of safety
and effectiveness," said Steven Schallhorn,
M.D., retired captain of the U.S. Navy, investigator
in multiple studies involving use of LASIK and other
refractive surgeries for treatment of nearsightedness,
farsightedness and astigmatism, and Medical Director
for Optical Express. "NASA followed the Naval
Aviation clinical studies closely with a particular
interest in both safety and quality of vision under
extreme conditions. Wavefront guided and femtosecond
lasers were proven to provide excellent safety with
consistent visual results of 20/20 or better. LASIK
was able to withstand even the most extreme rigors
of warfare and flight. All surgical procedures have
risks, but with this exceptional track record, the
average consumer has nothing to fear from LASIK."
LASIK is a two-step procedure. The IntraLase® FS
(femtosecond) laser replaces the hand-held microkeratome
blade historically used in creating LASIK corneal
flaps -- the first step of the procedure. The computer
guided, ultra-fast laser virtually eliminates almost
all of the most severe, sight threatening LASIK complications
related to microkeratomes. The laser creates an optimal
corneal surface below the flap, allowing for better
visual outcomes from the second step of the procedure
where wavefront guided technology maps, and then
custom-corrects vision based upon the unique characteristics
of an individual's eye. This sophisticated measurement
provides 25 times more precision than measurements
using standard methods for glasses and contact lenses.
LASIK'S FINAL FRONTIER
Though LASIK has been
around for almost a decade, concerns about the
harsh aviation environment prevented its use. To
date, aeromedical professionals have been cautious
of employing the procedure on military aviators
who frequently encounter environmental extremes
such as high altitude, dry air, wind blast and "G" forces.
In space, these and other conditions add even higher
levels of concern due to the extreme precision
needed during flight and space walks.
Dr. Schallhorn, himself a retired naval aviator,
spearheaded the majority of the Defense Department's
research in laser vision correction. Some notable
results of the many clinical trials conducted include:
An evaluation of Custom LASIK in 100 military personnel
showed that 95 percent achieved 20/20 uncorrected
vision or better; these patients, on average, were
previously only able to read the first line (the
big "E") of the vision assessment chart.1
In a study of different
methods to create the LASIK flap, 370 naval personnel
underwent bilateral wavefront-guided LASIK with either
the femtosecond laser or microkeratome blade. One
week after surgery more than 76 percent of femtosecond
laser patients achieved an uncorrected visual acuity
of at least 20/16 (better than 20/20) compared to
58 percent of microkeratome patients.2
In an evaluation of
785 aviators, 89% of Navy pilots rated their ability
to land on an aircraft carrier as moderately to significantly
better after laser vision correction. None said it
was worse after surgery.3
A separate study determined
that over 90 percent of marksmen had improvement
in marksmanship skills after laser vision correction;
a significant result given the visual precision of
marksmen.4
"
Today's news further
validates AMO as the global leader in laser vision
correction technologies," said Jim Mazzo, AMO
chairman, president and CEO. "Our Advanced CustomVue™ LASIK
with the IntraLase® Method is the only procedure
in the U.S. to incorporate the technologies specifically
approved for use by NASA."
In the U.S. laser vision correction market, the
Advanced CustomVue™ LASIK procedure with the
IntraLase® Method has become the new standard
and is rapidly becoming the most widely performed
laser vision correction procedure. In fact, the majority
of premier ophthalmic teaching institutions, including
Duke University Medical School, the Wilmer Eye Institute
at Johns Hopkins, the Bascom Palmer Eye Institute
at University of Miami, and Stanford University,
totaling over 16 domestic and international teaching
institutions use Advanced CustomVue™ LASIK
with the IntraLase® Method to train the next
generation of LASIK surgeons.
Advanced CustomVue™ LASIK with the IntraLase® Method
The Advanced CustomVue™ laser vision correction
procedure stands in a class of its own with the broadest
range of FDA-approved indications. When combined
with the power and precision of the IntraLase® Method,
the Advanced CustomVue™ procedure represents
the most advanced LASIK procedure available to patients
today. The IntraLase® FS laser, the first technology
for a blade-free LASIK procedure, replaces the handheld
microkeratome blade historically used in creating
LASIK corneal flaps -- the first step of the procedure
-- with a computer guided, ultra-fast femtosecond
(fem-to-second) laser. The IntraLase® laser virtually
eliminates the majority of the most severe sight-threatening
LASIK complications related to use of the microkeratome.5
Additionally, by creating an optimal corneal surface
below the flap, the IntraLase® Method provides
for better visual outcomes -- taking patients to
20/20 vision and beyond.6 More than one million LASIK
procedures using the IntraLase® Method have been
performed. With the company's acquisition of IntraLase® Corp.
in April of 2007, AMO is the only ophthalmic device
manufacturer in the U.S. to market a femtosecond
laser approved for use in creating LASIK corneal
flaps and other corneal incisions.
About Advanced Medical Optics (AMO)
AMO develops advanced,
life-improving vision technologies for people 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™, CustomVue®, IntraLase®,
and IntraLasik®. 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®,
COMPLETE® Blink-N-Clean®, Consept® F,
Consept® 1 Step, Oxysept® 1 Step, 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. Schallhorn and Mr.
Mazzo and statements relating to expected product
performance, trends and outcomes. All forward-looking
statements in this press release are based on estimates
and assumptions 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 including but not limited to
market developments, clinical experience, variations
in surgeon experience, and unexpected regulatory,
quality or supply issues. 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 2006 Form 10-K filed in March 2007 and second
quarter Form 10-Q. Copies of press releases and
additional information about AMO are available
at www.amo-inc.com.
Source:
Captain (Retired) Steven
C. Schallhorn, "US
Navy study: Custom
PRK versus custom LASIK".
Presented at the European
Society of Cataract
and Refractive Surgeons
annual meeting; September
8, 2006; London, UK.
Source: Tanzer DJ,
Schallhorn SC. Comparison
of visual outcomes
with femtosecond and
mechanical microkeratomes
for wavefront-guided
LASIK. Presented at
the American Academy
of Ophthalmology annual
meeting; November 13,
2006; Las Vegas, NV.
Source: Schallhorn
SC, Tanzer DJ, 'Refractive
Surgery in Naval Aviation',
Presented at the Aerospace
Medical Association
annual meeting, May
15, 2006, Orlando,
FL.
Source: Captain (Retired)
Steven C. Schallhorn, "Refractive
Surgery in the Navy",
Presented at the Aerospace
Medical Association
annual meeting; May
17, 1999; Detroit,
Michigan.
Source: Binder PS: "One
thousand consecutive
IntraLase laser in-situ
keratomileusis flaps" Journal
of Cataract and Refractive
Surgery. V32. June
2005.
Source: Durrie DS,
Kezirian, GM: "Femtosecond
Laser versus Mechanical
Keratome Flaps in Wavefront-guided
Laser in situ Keratomileusis:
A Prospective Contralateral
Eye Study" Journal
of Cataract and Refractive
Surgery, V31, Jan.
2005. .
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