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Panel Recommends FDA Approval of ARTISAN/VERISYSE Lens.

Business Editors & Health/Medical Writers

BOCA RATON, Fla., and SANTA ANA, Calif.--(BUSINESS WIRE)--Feb. 6, 2004

OPHTEC USA, Inc., a privately held medical device manufacturer and subsidiary of OPHTEC B.V. (Netherlands), and Advanced Medical Optics, Inc. (AMO) (NYSE: AVO), a global leader in ophthalmic surgical devices and eye care products, announced today that the U.S. Food and Drug Administration's (FDA) Ophthalmic Devices Panel of the Center for Devices and Radiological Health (CDRH) met yesterday and recommended that the ARTISAN(R)/VERISYSE(TM) phakic intraocular lens be approved by the FDA.

Yesterday's panel recommendation was on OPHTEC's PMA (pre-market approval application) for its ARTISAN(R) lens. The lens will be marketed in the U.S., under AMO's exclusive distribution agreement with OPHTEC, under the VERISYSE(TM) brand.

The panel recommended that the FDA approve the intraocular lens, or IOL, with conditions, for patients with myopia, or nearsightedness.

"The panel's positive recommendation means that, assuming approval by the FDA, the lens could be one of the first phakic IOLs offered commercially in the U.S.," said Rick McCarley, president and CEO of OPHTEC USA. "We are pleased with today's result and believe OPHTEC's three-year FDA study in the U.S. demonstrated to the panel that the ARTISAN(R)/VERISYSE(TM) phakic IOL is a safe and effective vision correction alternative."

"Today's announcement represents an important milestone in AMO's commitment to play a leadership role in the development of the refractive IOL marketplace and to provide leading-edge technologies to ophthalmic surgeons and their patients," said Jane Rady, corporate vice president of strategy and technology for Advanced Medical Optics. "Phakic IOLs are an exciting alternative for patients with severe nearsightedness that cannot be corrected through laser surgery. For these individuals, spectacles and contact lenses are currently the only options, and in cases of extreme nearsightedness spectacles are very thick and offer only a limited visual field. The VERISYSE(TM) lens, if approved for commercial use in the U.S., will give ophthalmologists an important additional tool in treating the needs of myopic patients."

The Ophthalmic Devices Panel is an advisory panel comprised primarily of ophthalmic practitioners and scientists. Although the FDA is not bound by the recommendations of its panels, it has historically accepted their advice. Among the conditions recommended by the panel for VERISYSE(TM) approval was an anterior chamber depth of more than 3.2 mm, as well as a post-market study. A final FDA decision is expected in approximately six months.

OPHTEC and AMO formed an agreement related to phakic IOLs while the current FDA study was already under way. OPHTEC was responsible for designing and conducting the study, and AMO provided assistance with the study analysis and the FDA review process.

Commenting on refractive IOL products, Dr. Doyle Stulting, M.D., Ph.D., who is on staff at the Department of Ophthalmology at the Emory University Eye Center where he is a professor of ophthalmology and the director of the university's Cornea Service, said, "As evidenced by the successful 13-year track record of this lens in Europe, it clearly would fill an unmet market need in the U.S. Approximately 90 million people in the U.S., or roughly one-third of the total U.S. population, are nearsighted. Based on the study's results, the VERISYSE(TM) phakic IOL provides excellent refractive outcomes -- 95 percent of study participants achieved manifest refraction spherical equivalents that were within 1 diopter of target.

"During the FDA study, lenses in whole-diopter increments were used. Once approved, lenses with 0.50 diopter increments will be introduced so that uncorrected vision is likely to be even better," Dr. Stulting added.

AMO, which has global distribution rights, currently markets the phakic IOL under the name VERISYSE(TM) in Europe, South America and portions of the Asia Pacific region. AMO will be the exclusive distributor for VERISYSE(TM) in North America and Japan. In addition, OPHTEC will continue to market the product under the trade name ARTISAN(R) in Europe. Even with approval of the VERISYSE(TM) lens in the U.S., AMO does not expect sales of phakic IOLs to make a material contribution to revenues in the near term.

About Phakic IOLs

Phakic IOL implantation, or the implantation of a lens where the natural, human lens remains intact, is viewed by many surgeons as becoming an alternative refractive treatment method for myopia, hyperopia and astigmatism. Originally used for the refractive correction of aphakia following cataract surgery, lens implants in Europe and around the world have experienced a renewed level of interest, particularly for patients with high refractive errors.

About the ARTISAN(R)/VERISYSE(TM) Phakic Lens

The current pre-market approval (PMA) application is for the correction of nearsightedness, or myopia, in phakic eyes. 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. The lens occupies the anterior chamber between the iris and corneal endothelium. The lens is designed to minimize the risk of endothelial cell loss and cataract formation associated with crystalline lens trauma.

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 400,000 aphakic OPHTEC lenses have been implanted worldwide, and an additional 100,000 phakic IOLs.


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 ARTISAN(R) Myopia Lenses, ARTISAN(R) Hyperopia Lenses, ARTISAN(R) Toric Lenses, ARTISAN(R) Pediatric Lenses, ARTIFLEX(TM) Foldable Phakic Lenses, 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 about the company and products contact Rick McCarley, president and CEO at, (561) 989-8767 or visit the parent company's website site at

About Advanced Medical Optics

Advanced Medical Optics, Inc. (AMO) is a global leader in the development, manufacturing and marketing of ophthalmic surgical and contact lens 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 foldable intraocular lenses, phacoemulsification systems, viscoelastics and related products used in cataract surgery, and microkeratomes used in LASIK procedures for refractive error correction. AMO owns or has the rights to such well-known ophthalmic surgical product brands as Phacoflex(R), Clariflex(R), Array(R) and Sensar(R) foldable intraocular lenses, the Sovereign(R) and Sovereign(R) Compact phacoemulsification systems with WhiteStar(TM) technology and the Amadeus(TM) microkeratome. Products in the contact lens care line include disinfecting solutions, daily cleaners, enzymatic cleaners and lens rewetting drops. Among the well-known 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.

Advanced Medical Optics, Inc. is based in Santa Ana, California, and employs approximately 2,000 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

Forward-Looking Statements

This press release contains forward-looking statements about AMO, OPHTEC, and their businesses, such as Mr. McCarley's, Ms. Rady's, and Dr. Stulting's statements, and statements about the FDA approval and product launch of this product and future product offerings. Any statements in this press release that refer to AMO's anticipated distribution of this and future products, and 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 or OPHTEC's businesses, including but not limited to the ability of the FDA to reject the panel's recommendation to approve the product or to impose significant product labeling conditions; competitive, regulatory and market conditions; the performance acceptance of new products and the continuing acceptance of current products; OPHTEC's ability to supply products; the execution of strategic initiatives; and the uncertainties associated with intellectual property protection for these products. In addition, matters generally affecting the domestic and global economy, such as changes in interest and currency exchange rates, can affect AMO's results. 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 can be found in press releases issued by AMO as well as 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 2002 Form 10-K and in AMO's Form 10-Q for the quarter ended September 26, 2003, also include information concerning these and other risk factors. Copies of press releases and additional information about AMO are available on the World Wide Web at, or you can contact the AMO Investor Relations Department by calling 714-247-8348.
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Publication:Business Wire
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Date:Feb 6, 2004
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