Advanced Medical Optics Presents to the U.S. Food and Drug Administration's Ophthalmic Devices Panel of the Medical Devices Advisory Committee
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Advanced Medical Optics (AMO) (NYSE:EYE) today announced its continued
support and cooperation with the U.S. Food and Drug Administration (FDA)
regarding the enhancement of product safety and effectiveness of contact
lens care products.
AMO’s presentation before the FDA’s
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
addressed several general issues regarding the safety and effectiveness
of contact lens solutions and demonstrated that infection control is a
complex issue that involves more than the formulation of the solution
itself.
"Rub and rinse has been proven to improve
effectiveness against Acanthamoeba and other microorganisms,”
said David Hansen, O.D., director of professional services, AMO. "We
firmly believe that it should be an integral part of an effective
contact lens hygiene regimen,” he finished.
Safe use of contact lens care products depends heavily on the patient’s
compliance with labeled instructions for use. Specifically, the company
emphasized that it is focused on the education of eye care professionals
and patients on proper lens care compliance and that real-world testing
of contact lens care products should be considered when evaluating
product safety and efficacy.
"AMO is committed to protecting the ocular
health of people who wear contact lenses and use lens care products,” said
Russ Trenary, executive vice president, global public policy and medical
education at AMO. "We support safety measures
that provide patients with appropriate steps for proper handling,
disinfection and hygiene of contact lenses.”
The company, which manufactures the COMPLETE®
brand of eye care products, also shared information on ways to minimize
the risk of infections such as Acanthamoeba keratitis among people who
wear contact lenses and underscored the importance of proper handling,
disinfection and hygiene when using contact lenses and contact lens
products.
The company also addressed the FDA’s interest
in evaluating preclinical microbiology test methods to better serve as
predictors of real world product performance. AMO supports establishing
standards for testing the effectiveness of contact lens solutions in
effectively disinfecting against a broad range of organisms in the best
interest of the patients who use its products. "We
look forward to collaborating with the FDA on the most effective and
appropriate path forward because we share their interest in controlling
infections,” said Trenary. "Per
our routine policy, we will comply with new FDA standards and/or
labeling decisions and take any requested actions within the allotted
timeframe.” About Advanced Medical Optics (AMO)
AMO is focused on providing the full range of advanced refractive
technologies and support to help eye care professionals deliver optimal
vision and lifestyle experiences to patients of all ages. Products in
the cataract line include monofocal intraocular lenses (IOLs),
phacoemulsification systems, viscoelastics, and related products used in
ocular surgery. AMO owns or has the rights to such product brands as
Tecnis®, Clariflex®
and Sensar® IOLs; Sovereign®,
Sovereign® Compact and WhiteStar Signature™
phacoemulsification systems with WhiteStar®
technology; Healon® viscoelastics and the
Baerveldt® glaucoma shunt. Products in the
refractive line include wavefront diagnostic devices, femtosecond lasers
and associated patient interface devices; excimer laser vision
correction systems and treatment cards, and refractive implants. AMO
brands in the refractive business include iDesign™,
iFS™, Star S4 IR®,
WaveScan Wavefront®, Advanced CustomVue™,
IntraLase®, IntraLasik®
and ReZoom®, Tecnis®
Multifocal and Verisyse® IOLs.
Products in the eye care line include disinfecting solutions, enzymatic
cleaners, lens rewetting drops and artificial tears. 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 4,000 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 Mr. Hansen and Mr. Trenary and statements
relating to AMO's product performance and patient compliance through
education and labeling, and the industry’s
ability to develop standardized clinical and real world testing for
disinfection against a broad range of microorganisms. All
forward-looking statements in this press release 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.
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 2007 Form 10-K filed in March 2008. Copies of press releases and
additional information about AMO are available at www.amo-inc.com.