18.07.2007 10:00:00
|
Advanced Medical Optics Receives FDA Approval for Advanced CustomVue(TM) Monovision Procedure for the Treatment of Presbyopic Myopes
Advanced Medical Optics, Inc. (AMO) [NYSE:EYE],
a global leader in ophthalmic surgical devices and eye care products,
today announced the U.S. Food and Drug Administration (FDA) has approved
the Advanced CustomVue™ Monovision procedure,
the first wavefront-guided laser vision correction procedure for the
visual correction of myopic (nearsighted) presbyopic patients, with and
without astigmatism.
"This approval marks another industry first
for AMO,” said Jim Mazzo, AMO chairman,
president and CEO. "The Advanced CustomVue™
Monovision procedure is the only FDA-approved wavefront-guided LASIK
treatment for the correction of both near and distance vision of
presbyopic patients.”
Greek for "aging eye,”
presbyopia is part of the natural aging process and affects most people
sometime in their 40s. The condition causes the lens of the eye to lose
flexibility, gradually diminishing its ability to focus on objects
up-close. An estimated 90 million people in the United States have
presbyopia, and nearly a third of them could benefit from the Advanced
CustomVue™ Monovision procedure.
The Advanced CustomVue™ Monovision treatment
can improve both near and distance vision utilizing AMO’s
Advanced CustomVue™ LASIK technologies,
including the Star S4 IR® excimer laser and
the WaveScan Wavefront®
and Iris Registration™ technologies, to first
map, and then custom-correct nearsightedness in the dominant eye, and
partially correct nearsightedness in the other eye. The procedure is
individualized for the unique correction requirements of presbyopic
patients with low to moderate myopia, with and without astigmatism. The
result is a reduced dependency on reading glasses and contact lenses.
The term monovision refers to a common method of vision correction for
the management of presbyopia. In monovision, the dominant eye is
corrected for distance vision, and the other eye for near vision. The
brain learns to distinguish which eye sees near and which sees far.
The FDA based its approval on clinical data from a multi-center clinical
trial, involving 160 patients for up to two years.
According to the clinical trial results, six months after being treated
with the Advanced CustomVue™ Monovision
procedure:
100 percent of patients achieved 20/40 or better vision at both
distance and near.
100 percent of patients achieved binocular uncorrected near-vision of
20/40 or better.
100 percent of patients achieved binocular uncorrected distance-vision
of 20/40 or better.
More than 96 percent of patients decreased their use of corrective
lenses.
After 12 months:
When asked if they would have the Advanced CustomVue™
Monovision procedure again, more than 98 percent of patients said they
would.
More than 88 percent of patients achieved 20/20 or better uncorrected
intermediate-vision.
100 percent of patients achieved 20/32 or better uncorrected
intermediate-vision.
"With the aging population, the number of
patients requiring age-related vision correction will only grow,”
said Mazzo. "AMO is making LASIK a viable
option for the presbyopic generation. This demonstrates our commitment
to delivering the very best technology for our surgeons, and the very
best outcomes for their patients of all ages.”
With this FDA approval, AMO continues to be uniquely positioned to
provide the broadest range of wavefront-guided treatments for any
patient interested in laser vision correction and the Advanced CustomVue™
procedure. AMO expects the procedure to be widely available to U.S.
LASIK patients before the end of 2007.
As a first-in-class technology, AMO will be conducting a short
post-marketing surveillance study on the Advanced CustomVue™
Monovision treatment as part of its U.S. launch.
About Advanced CustomVue™ Monovision
The Advanced CustomVue™ Monovision procedure
is individualized for the unique correction requirements of presbyopic
patients with low to moderate myopia and astigmatism and is the only
FDA-approved monovision treatment performed with an excimer laser. The
procedure combines the WaveScan WaveFront®
system with AMO’s Iris Registration™
technology, a fully automated, non-contact and more precise method for
aligning and registering wavefront corrections, to capture the unique
imperfections in each individual’s eye that
could not have been measured before using standard methods for
corrective glasses and contact lenses.
About Advanced Medical Optics, Inc. (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®,
CustomVue®,
IntraLase®
FS, IntraLase Method™
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 Mr. Mazzo’s statements and those
relating to the launch features and expected benefits of the product as
well as estimated patient populations. 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,
expanded clinical experience, unexpected delays in manufacturing,
demographic changes, and unexpected regulatory or quality 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 first-quarter Form 10-Q.
Copies of press releases and additional information about AMO are
available at www.amo-inc.com.
Der finanzen.at Ratgeber für Aktien!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
JETZT DEVISEN-CFDS MIT BIS ZU HEBEL 30 HANDELN
Handeln Sie Devisen-CFDs mit kleinen Spreads. Mit nur 100 € können Sie mit der Wirkung von 3.000 Euro Kapital handeln.
82% der Kleinanlegerkonten verlieren Geld beim CFD-Handel mit diesem Anbieter. Sie sollten überlegen, ob Sie es sich leisten können, das hohe Risiko einzugehen, Ihr Geld zu verlieren.
Nachrichten zu Abbott Laboratoriesmehr Nachrichten
Analysen zu Abbott Laboratoriesmehr Analysen
Aktien in diesem Artikel
Abbott Laboratories | 110,64 | -1,02% |
Indizes in diesem Artikel
S&P 600 SmallCap | 935,46 | -0,94% |