SANTA ANA, Calif., Jan. 3 /PRNewswire-FirstCall/ -- Advanced Medical
Optics, Inc. (AMO) (NYSE: EYE), a global ophthalmic surgical and eye care
products company, announced today that the U.S. Food and Drug Administration
(FDA) has recommended that the company enroll additional subjects in its U.S.
clinical study for the Tecnis® Multifocal intraocular lens (IOL). AMO still
intends to file a premarket approval (PMA) application for the Tecnis®
Multifocal IOL next month in accordance with its original plan to launch the
product in the U.S. in the first half of 2008. However, in light of the
latest questions raised by the FDA, the company now believes there is a
reasonable likelihood the launch timeline could be extended by approximately
"We believe the Tecnis® Multifocal IOL data from our U.S. clinical trial
are compelling and unrelated to the FDA's questions," said Dr. Leonard
Borrmann, AMO corporate vice president, research and development. "Rather,
the possible delay is related to sample size assumptions from the protocol
established in the investigational device exemption (IDE) application that was
approved by the FDA before our U.S. trial commenced in late 2004. We respect
the FDA's views and intend to continue a dialogue with them in an effort to
satisfy their questions."
AMO offers a full portfolio of refractive IOLs including:
* ReZoom(TM) multifocal IOL -- approved by the FDA in 2005 and designed
to provide near, intermediate and distance vision. The ReZoom(TM)
IOL is sold in select global markets and is the company's most widely
sold multifocal lens.
* Verisyse(TM) phakic IOL -- for patients with higher levels of myopia
or who are not good candidates for LASIK. AMO also offers the
foldable Veriflex(TM) phakic IOL in Europe.
* Tecnis(R) Multifocal IOL -- a full diffractive, aspheric optic that
is intended to provide a full range of vision. It is currently
approved for use in Europe and various other international markets.
About Advanced Medical Optics (AMO)
AMO is a global medical device leader focused on the discovery and
delivery of innovative vision technologies that optimize the quality of life
for people of all ages. Products in the ophthalmic surgical line include
intraocular lenses, laser vision correction systems, phacoemulsification
systems, viscoelastics, microkeratomes and related products used in cataract
and refractive surgery. AMO owns or has the rights to such ophthalmic
surgical product brands as ReZoom(TM), Clariflex®, Sensar®, CeeOn®,
Tecnis® and Verisyse(TM) intraocular lenses, STAR S4 IR(TM) laser vision
correction system, WaveScan Wavefront® System, CustomVue(TM) procedure,
Sovereign® and Sovereign® Compact(TM) phacoemulsification systems with
WhiteStar® technology, Amadeus(TM) and Amadeus(TM) II microkeratomes,
Healon® viscoelastics, and the Baerveldt® glaucoma shunt. 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 Moisture PLUS®, COMPLETE® Blink-N-Clean®, Consept®F,
Consept® 1 Step, Oxysept® 1 Step, UltraCare®, Ultrazyme®, Total
Care(TM) and blink(TM) branded products. Amadeus is a licensed product of,
and a trademark of, SIS, Ltd. AMO is based in Santa Ana, California, and
employs approximately 3,800 worldwide. The company has operations in 24
countries and markets products in approximately 60 countries. For more
information, visit the company's Web site at www.amo-inc.com.
Statements in this press release regarding U.S. filing approval and launch
dates for the Tecnis® Multifocal lens, statements of Dr. Borrmann and any
other statements in this press release that refer to AMO's estimated or
anticipated future results, are forward-looking statements. All
forward-looking statements in this press release reflect AMO's current
analysis of existing trends and information 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 affecting AMO's businesses including
but not limited to changing competitive, regulatory and market conditions; the
performance of new products; the unpredictable nature of governmental approval
processes; and the execution of strategic initiatives and alliances.
Therefore, the reader is cautioned not to rely on these forward-looking
statements. AMO disclaims any intent or obligation to update these
Additional information concerning these and other risk factors may be
found in previous financial press releases issued by AMO. AMO's public
periodic filings with the Securities and Exchange Commission, including the
discussion under the heading "Risk Factors" in AMO's 2005 Form 10-K filed in
March 2006 include information concerning these and other risk factors.
Copies of press releases and additional information about AMO are available at
www.amo-inc.com, or by contacting AMO's Investor Relations Department by
Advanced Medical Optics, Inc.
SOURCE Advanced Medical Optics, Inc.
CONTACT: Investors, Sheree Aronson, +1-714-247-8290,
firstname.lastname@example.org, or Media, Steve Chesterman, +1-714-247-8711,
email@example.com, both of Advanced Medical Optics, Inc.