September 21, 2007
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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