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Advanced Medical Optics and OPHTEC USA Announce FDA Approval of the Verisyse(TM) / ARTISAN(R) Phakic Intraocular Lens SANTA ANA, Calif. and BOCA RATON, Fla., Sept. 13 /PRNewswire-FirstCall/ -- Advanced Medical Optics, Inc. (AMO) (NYSE:AVO), a global leader in ophthalmic surgical devices and eye care products, and OPHTEC USA, Inc., a privately held medical device manufacturer and subsidiary of OPHTEC B.V. (Netherlands), announced today that the U.S. Food and Drug Administration (FDA) has approved the Verisyse(TM) / ARTISAN(R) phakic intraocular lens (IOL) for use in patients with myopia, or nearsightedness. (Photo: http://www.newscom.com/cgi-bin/prnh/20040913/LAM066) The Verisyse(TM) / ARTISAN(R) phakic IOL is the first lens of its kind to receive FDA approval. The unique, patented lens design was introduced by OPHTEC in Europe more than 17 years ago and has been safely implanted in more than 150,000 eyes worldwide. OPHTEC BV manufactures and distributes the lens under the trade name ARTISAN(R) in all markets except North America and Japan. In 2002, AMO acquired global distribution rights to the phakic IOL, which it markets under the Verisyse(TM) brand. AMO is the exclusive source for the product in North America and Japan. The FDA-approved product labeling will indicate that the Verisyse(TM) / ARTISAN(R) lens is suitable for the reduction or elimination of myopia in adults with myopia ranging from -5.0 to -20.0 diopters and in patients aged 21 and over. The FDA approval followed OPHTEC USA's submission of a Pre-Market Approval (PMA) application, which received expedited review status in August 2003. "AMO is committed to playing a leadership role in the development of the global refractive IOL marketplace," said James V. Mazzo, AMO president and chief executive officer. "Approval of the lens in the U.S. marks an important step forward in our goal to build a comprehensive product portfolio that can provide a full range of options to ophthalmic surgeons and their patients." AMO is currently coordinating surgeon training and certification for the Verisyse(TM) lens in the U.S. and expects to begin releasing the product to trained surgeons by October. Information about the Verisyse lens and procedure is available at http://www.visioninfocus.com/. "This technology provides an excellent alternative for surgeons whose myopic patients may not be good candidates for laser surgery and want to eliminate their dependence on glasses or contact lenses," said Jane E. Rady, corporate vice president of strategy and technology for AMO. "The progressive design of the lens and its placement in the eye's anterior chamber provide high levels of safety and stability, and optimal visual outcomes." "This approval represents a significant development in refractive surgery technology," said Rick McCarley, president and chief executive officer of OPHTEC USA, who conducted the U.S. study over the past seven years. "The Verisyse(TM) / ARTISAN(R) lens provides superior quality of vision, especially for individuals with high myopia. Unlike laser surgery, implantation of phakic lenses involves no removal of tissue, and the lens can be easily removed at any time in the future. In addition, the Verisyse(TM) / ARTISAN(R) lens design has the longest human experience of any phakic IOL and accounts for the largest percentage of phakic lens implantations worldwide." AMO and OPHTEC announced in May that the two firms signed an agreement to collaborate on the design, development and U.S. regulatory approval process for the Veriflex(TM), a foldable version of the Verisyse(TM) / ARTISAN(R) phakic IOL. OPHTEC is currently engaged in clinical trials in Europe on a foldable phakic IOL. AMO and OPHTEC plan to continue to improve the foldable lens design and develop a compatible insertion system. AMO and OPHTEC also plan to share responsibility for submission to the FDA of the PMA application for the Veriflex(TM) lens and implementation of U.S. human clinical trials. Once approved, AMO will be the exclusive worldwide source for the Veriflex(TM) lens. OPHTEC will market the foldable ARTISAN(R) as the ARTIFLEX(TM) in all markets except North America and Japan. About Phakic IOLs Phakic IOL implantation, or the implantation of a lens in which the natural, human lens remains intact, is viewed by many surgeons as an alternative refractive treatment method for myopia, hyperopia and astigmatism. The parent design was originally used for the refractive correction of aphakia following cataract surgery. Now, surgeons in Europe and around the world have experienced a renewed level of interest in lens implants, particularly for patients with high refractive errors. About the Verisyse(TM) / ARTISAN(R) Phakic IOL With its unique iris fixation method, OPHTEC's phakic IOL technology enables the lens to attach to the non-reactive, mid-periphery of the iris in a way that does not inhibit the iris' function. This unique location allows placement at a safe distance from the natural lens, the cornea, and the anterior chamber angle. This unique lens design was conceived by international award-winning ophthalmologist Professor Jan Worst, M.D. of Groningen, The Netherlands, and first introduced in 1978 for the correction of aphakia following cataract surgery. Its design was later modified and has been used in the phakic eye for the last 13 years. Since its original introduction, over 500,000 aphakic OPHTEC lenses have been implanted worldwide, as well as an additional 150,000 phakic IOLs. About OPHTEC USA OPHTEC USA, Inc. is a privately held, wholly owned subsidiary of OPHTEC BV, Groningen, The Netherlands. OPHTEC designs, manufactures, markets and distributes ophthalmic medical devices used in anterior segment surgery. Primary product lines include the patented ARTISAN(R) Line: ARTISAN(R) Myopia Lenses, ARTISAN(R) Hyperopia Lenses, ARTISAN(R) Toric Lenses, ARTISAN(R) Pediatric Lenses, ARTIFLEX(TM) Foldable Phakic Lenses, and OPHTEC Capsular Tension Rings, Custom Artificial Iris Implants and the IPS(TM) Iris Prosthetic System. Worldwide marketing and distribution of products is achieved through direct sales or through exclusive distributorship arrangements. For more information visit the parent company's website site at http://www.ophtec.com/. About Advanced Medical Optics Advanced Medical Optics, Inc. (AMO) is a global leader in the development, manufacturing and marketing of ophthalmic surgical and eye care products. The company focuses on developing a broad suite of innovative technologies and devices to address a wide range of eye disorders. Products in the ophthalmic surgical line include intraocular lenses, 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 Phacoflex(R), Clariflex(R), Array(R), Sensar(R), CeeOn(R), Tecnis(R) and Verisyse(TM) intraocular lenses, Sovereign(R) and Sovereign(R) Compact(TM) phacoemulsification systems with WhiteStar(TM) technology, Amadeus(TM) microkeratome, Healon(R) and Vitrax(R) viscoelastics, and the Baerveldt(R) glaucoma shunt. Products in the contact lens care line include disinfecting solutions, daily cleaners, enzymatic cleaners and lens rewetting drops. Among the contact lens care product brands the company possesses are COMPLETE(R) Moisture PLUS(TM), COMPLETE(R) Blink-N-Clean(R), Consept(R) F, Consept(R) 1 Step, Oxysept(R) 1 Step, UltraCare(R), Ultrazyme(R), Total Care(R) 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 2,800 worldwide. The company has operations in about 20 countries and markets products in approximately 60 countries. For more information, visit the company's Web site at http://www.amo-inc.com/. Forward-Looking Statements Statements in this press release such as Mr. Mazzo's, Ms. Rady's and Mr. McCarley's statements, and statements regarding product availability and future products, and any other statements 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 unexpected changes in competitive, regulatory and market conditions, AMO's ability to obtain adequate product supply and produce successful collaborative efforts, unexpected litigation or intellectual property issues, and the uncertainties associated with market acceptance of new products. 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 "Certain Factors and Trends Affecting AMO and its Businesses" in AMO's 2003 Form 10-K and Form 10-Q filed August 2004 also includes information concerning these and other risk factors. Copies of press releases and additional information about AMO are available on the World Wide Web at http://www.amo-inc.com/, or you can contact the AMO Investor Relations Department by calling 714-247-8348. Verisyse "Fair Balance" information Intended Use Statement: Verisyse(TM) Phakic Intraocular Lenses are intended for the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3.2 mm, and patients with documented stability of manifest refraction for the prior six months as demonstrated by a spherical equivalent change of less than or equal to 0.50 diopters. Rx Only. Precautions: Do not resterilize this lens by any method; do not store the lens at temperatures over 45 degrees Celsius (113 degrees Fahrenheit). Warnings: Surgeons should consider the risk/benefit ratio for adults with preoperative ocular pathology, including but not limited to inflammation, distorted eye and microbial infection. Adverse Events: Adverse events that have been documented as having occurred following lens implantation include, but are not limited to, hyphema, retinal detachment and lens dislocation. For a complete listing of precautions, warnings and adverse events, refer to the package insert. For further information, please contact: Investors, Sheree Aronson, +1-714-247-8290, , or Media, Steve Chesterman, +1-714-247-8711, , both of Advanced Medical Optics, Inc. http://www.newscom.com/cgi-bin/prnh/20040913/LAM066 DATASOURCE: Advanced Medical Optics, Inc. CONTACT: Investors, Sheree Aronson, +1-714-247-8290, , or Media, Steve Chesterman, +1-714-247-8711, , both of Advanced Medical Optics, Inc. Web site: http://www.ophtec.com/ Web site: http://www.visioninfocus.com/ Web site: http://www.amo-inc.com/

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