SANTA ANA, Calif. & BOCA RATON, Fla.--(BUSINESS WIRE)--April 28, 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), today announced Federal Drug Administration (FDA) approval of the StabilEyes(TM) capsular tension ring (CTR).
As a result of the FDA approval, AMO will begin sales and marketing of the StabilEyes(TM) CTR throughout North America. AMO will be the sole source of the StabilEyes(TM) CTR in the United States, Canada and Mexico.
"The StabilEyes(TM) CTR is an important new technology for ophthalmic surgeons and their patients, and AMO is the first company with a comprehensive cataract offering to bring this exciting new technology to the US marketplace," said Russ Trenary, chief marketing officer of AMO. "Capsular tension rings, like StabilEyes(TM), offer the surgeon a new level of safety for complicated cataract cases. By stabilizing the capsular bag with StabilEyes(TM), surgeons will have the ability to easily perform successful posterior chamber IOL implantation when the integrity of the capsular bag is, or may become compromised."
OPHTEC USA was granted expedited review status by the FDA for the StabilEyes(TM) CTR last September and has been manufacturing CTRs under the Oculaid(R) brand name outside of North America for more than 10 years. OPHTEC USA began investigational studies in the United States in 2001.
"We're excited to expand the availability of the StabilEyes(TM) capsular tension ring to the North American market," said Rick McCarley, president of OPHTEC USA, Inc. "We expect this proven technology to be used routinely in certain cataract surgeries in the future, helping to improve patient outcomes."
The StabilEyes(TM) CTR is a device designed for permanent implantation into the human capsular bag during cataract removal surgery. It provides secondary capsular bag support in the presence of compromised zonules. The CTR is a uniplanar, 270-degree, semi-circle ring made entirely of an ultraviolet light absorbing polymethylmethacrylate (PMMA) with one manipulation eyelet at each end of the ring. The CTR is intended for placement into the equator of the capsular bag during cataract surgery by using either forceps or a specially designed insertion instrument. StabilEyes(TM) CTRs are available in 12mm diameter and 13mm diameter sizes.
About Capsular Tension Rings
A capsular tension ring is an open, circular-shaped filament made of polymethylmethacrylate (PMMA). It is designed to help stabilize the eye's capsular bag (especially in individuals with weak or broken zonules) during cataract surgery in combination with the implantation of an intraocular lens. Zonules are the small fibers that work in conjunction with the ciliary muscle to adjust the shape of the crystalline lens. When the ciliary muscle contracts, the zonules relax and the lens increases its curvature, allowing light rays to refract (bend) for near vision. When the ciliary muscle relaxes, tension is applied to the zonules, which causes the lens to flatten and subsequently focus on distant objects.
Approximately one-to-three percent of cataract patients encounter damaged or broken zonules during the course of surgery. Some complications of cataract surgery with weakened zonules include dislocation of the lens, vitreous loss, lens subluxation into the vitreous, the need to position the intraocular lens in another part of the eye, and ultimately the loss of optimal visual acuity. Having a capsular tension ring available during all cataract procedures may allow surgeons to increase their overall success rates.
Cataract removal and implantation of an intraocular lens is the most common surgical procedure in the United States and most other developed nations.
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 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 eye care line include contact lens 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. Oculaid is a trademark of OPHTEC B.V.
Advanced Medical Optics, Inc. is based in Santa Ana, California, and employs approximately 2,300 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 www.amo-inc.com.
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. 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 email@example.com, (561) 989-8767 or visit the parent company's website site at www.ophtec.com.
This press release contains forward-looking statements about AMO, OPHTEC, and their businesses, such as Mr. Trenary's and Mr. McCarley's statements, and statements about the product benefits. Any statements in this press release that refer to AMO's anticipated distribution of the product, 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 unpredictable competitive, regulatory and market conditions; the performance acceptance of new products; OPHTEC's ability to supply products; the execution of strategic initiatives; and the uncertainties associated with intellectual property protection for these 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 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 www.amo-inc.com, or you can contact the AMO Investor Relations Department by calling (714) 247-8348.
Advanced Medical Optics, Inc.
Sheree Aronso (Investors), 714-247-8290
Steve Chesterman (Media), 714-247-8711
OPHTEC USA, Inc.
Rick McCarley, 561-989-8767