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Devices Ophthalmology FDA

 News Release - July 18, 2007

Advanced Medical Optics Receives FDA Approval for Advanced CustomVue(TM) Monovision Procedure for the Treatment of Presbyopic Myopes

First LASIK Procedure Approved for the Millions of Nearsighted People Who Struggle with Age-Related Difficulty with Near Vision

SANTA ANA, Calif.--(HSMN NewsFeed)--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(TM) 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(TM) 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(TM) Monovision procedure.

The Advanced CustomVue(TM) Monovision treatment can improve both near and distance vision utilizing AMO's Advanced CustomVue(TM) LASIK technologies, including the Star S4 IR® excimer laser and the WaveScan Wavefront® and Iris Registration(TM) 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(TM) 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(TM) 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(TM) 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(TM) Monovision treatment as part of its U.S. launch.

About Advanced CustomVue(TM) Monovision

The Advanced CustomVue(TM) 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(TM) 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(TM) 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(TM) 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(TM)F, Consept(TM) 1 Step, Oxysept® 1 Step, UltraCare®, Ultrazyme®, Total Care(TM) and blink(TM) 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.


Source: Advanced Medical Optics

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