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Video:
NASA Approves Advanced Lasik for Use on Astronauts
AMO's Advanced CustomVue(TM)
LASIK with
the IntraLase® Method Proves Ready for the
Rigors of Space
Travel
SANTA ANA, Calif., Sept. 21 /PRNewswire-FirstCall/
-- 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(TM) LASIK with the IntraLase®
Method, which showed the combination of technologies
provides superior safety and vision.
To view the Multimedia News Release, go to:
http://www.prnewswire.com
/mnr/intralase/29864/
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(TM) 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(TM) 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(TM)
LASIK with the IntraLase® Method to train the
next generation of LASIK surgeons.
Advanced CustomVue(TM) LASIK with the IntraLase®
Method
The Advanced CustomVue(TM) 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(TM) 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(TM) 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(TM), 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(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 http://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 http://www.amo-inc.com.
(1) 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.
(2) 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.
(3) Source: Schallhorn SC, Tanzer DJ, 'Refractive
Surgery in Naval Aviation', Presented at the Aerospace
Medical Association annual meeting, May 15, 2006,
Orlando, FL.
(4) Source: Captain (Retired) Steven C. Schallhorn,
"Refractive Surgery in the Navy", Presented
at the Aerospace Medical Association annual meeting;
May 17, 1999; Detroit, Michigan.
(5) Source: Binder PS: "One thousand consecutive
IntraLase laser in-situ keratomileusis flaps"
Journal of Cataract and Refractive Surgery. V32.
June 2005.
(6) 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 andRefractive
Surgery, V31, Jan. 2005.
SOURCE Advanced Medical
Optics, Inc.
CONTACT: Media, Liana Miller, liana@eluminatepr.com,
or Kimberly
Capwelle, both of eLuminatePR, +1-949-276-8920,
for Advanced Medical Optics,
Inc.; or Steve Chesterman, Manager, Corporate Communications,
+1-714-247-8711,
steve.chesterman@amo-inc.com, or Investors, Sheree
Aronson, Corporate Vice
President, Investor Relations and Corporate Communications,
+1-714-247-8290,
sheree.aronson@amo-inc.com, or Mark Levin, Manager,
Investor Relations,
+1-714-247-8465, mark.levin@amo-inc.com, all of
Advanced Medical Optics, Inc.
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