SANTA ANA, Calif., Jan. 3 /PRNewswire-FirstCall/ -- Advanced Medical Optics, Inc. (AMO) , 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(R) Multifocal intraocular lens (IOL). AMO still intends to file a premarket approval (PMA) application for the Tecnis(R) 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 12-18 months.
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“We believe the Tecnis(R) 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(R), Sensar(R), CeeOn(R), Tecnis(R) and Verisyse(TM) intraocular lenses, STAR S4 IR(TM) laser vision correction system, WaveScan Wavefront(R) System, CustomVue(TM) procedure, Sovereign(R) and Sovereign(R) Compact(TM) phacoemulsification systems with WhiteStar(R) technology, Amadeus(TM) and Amadeus(TM) II microkeratomes, Healon(R) viscoelastics, and the Baerveldt(R) 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(R), COMPLETE(R) Blink-N-Clean(R), Consept(R)F, Consept(R) 1 Step, Oxysept(R) 1 Step, UltraCare(R), Ultrazyme(R), 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.
Forward-Looking Statements
Statements in this press release regarding U.S. filing approval and launch dates for the Tecnis(R) 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 forward-looking statements.
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 calling 714-247-8455.
Advanced Medical Optics, Inc. Investors: Sheree Aronson (714) 247-8290 sheree.aronson@amo-inc.com Media: Steve Chesterman (714) 247-8711 steve.chesterman@amo-inc.com
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CONTACT: Investors, Sheree Aronson, +1-714-247-8290,sheree.aronson@amo-inc.com, or Media, Steve Chesterman, +1-714-247-8711,steve.chesterman@amo-inc.com, both of Advanced Medical Optics, Inc.
Web site: http://www.amo-inc.com/
