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FDA Approves Verisyse

First Phakic Intraocular Lens to Receive Approval in the U.S.A.

 

SANTA ANA, Calif. and BOCA RATON, Fla., Sept. 13, 2004

 

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 ARTISAN®/ Verisyse™ phakic intraocular lens (IOL) for use in patients with myopia,

or nearsightedness.

The ARTISAN®/ Verisyse™ 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® 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™ brand. AMO is the exclusive source for the product in North America and Japan.

The FDA-approved product labeling will indicate that the ARTISAN®/ Verisyse™ 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™ 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 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 ARTISAN®/ Verisyse™ 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 ARTISAN®/ Verisyse™ lens design has the longest human experience of any phakic IOL and accounts for the largest percentage of phakic lens implantations worldwide."

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.

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.

 

Dr. Huang at the Doheny Laser Vision Center performs the Verisyse procedure for the treatment of severe nearsightedness.