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Allergan Announces Partnership With OPHTEC BV and OPHTEC USA.


Business Editors & Health/Medical Writers

IRVINE, Calif.--(BW HealthWire)--Jan. 16, 2002

Allergan To Become Official Distributor of OPHTEC's Phakic IOLs

and To Develop New Allergan-Branded Phakic IOL IOL Intraocular lens, see there  Product in 2002

Allergan, Inc. (NYSE NYSE

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AGN Air Gabon (ICAO code) 
) today announced it has signed a contract with OPHTEC BV and OPHTEC USA, Inc., the Netherlands-based medical device manufacturer. Under the terms of the agreement, Allergan will seek to introduce a new Phakic intraocular lens Intraocular lens
Lens made of silicone or plastic placed within the eye; can be corrective.

Mentioned in: Cataract Surgery
 (IOL) based on OPHTEC's ARTISAN(TM) lens technology. Once regulatory approval is received in North America and Japan, Allergan will market this new brand of Phakic IOL exclusively. In the European Region and the rest of the world, OPHTEC will continue to distribute the ARTISAN(TM) lens and Allergan will market and sell its own brand. Allergan intends to launch the new product in 2002 in Europe and other approved select markets around the world.

"Phakic IOLs are an exciting development, especially for patients who are outside the corrective range of traditional refractive surgery Refractive surgery
A surgical procedure that corrects visual defects.

Mentioned in: Photorefractive Keratectomy and Laser-Assisted In-Situ Keratomileusis

refractive surgery 
," said Mike Judy, Allergan's Director, Global Surgical Business, IOLs. "With the growing

interest around the world among surgeons and patients for refractive refractive

capacity to refract light.


refractive error
a difference between the focal length of the cornea and lens, and the length of the eye, resulting in myopia or hyperopia.
 surgical procedures, Allergan is pleased to be expanding its refractive product offerings through the partnership with OPHTEC."

ARTISAN(TM) Phakic IOLs are intended for use in refractive surgery for the correction of myopia myopia: see nearsightedness. , hyperopia hyperopia (hī'pərō`pēə): see farsightedness.  and astigmatism astigmatism (əstĭg`mətĭz'əm), type of faulty vision caused by a nonuniform curvature in the refractive surfaces—usually the cornea, less frequently the lens—of the eye. . The product currently has CE Marking in Europe. It is not currently approved in the U.S. but is under Phase III clinical trials in the United States under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  (IDE).

A Growing Refractive Market

The refractive surgical market has experienced significant growth over the last few years, with 1.5 million refractive surgical procedures performed in the United States and 3 million performed worldwide in 2001.

"Phakic IOLs represent one of the fastest growing segments in the European refractive surgical market," said Jim Mazzo, Allergan's Corporate VP & President, Europe & Global Surgical Business. "Allergan's partnership with OPHTEC creates a significant opportunity for Allergan to strengthen its leadership position in this segment."

"We are delighted to be working with Allergan to broaden the refractive surgical options available to surgeons and patients worldwide," said Erik-Jan Worst, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of OPHTEC BV. "With our strong 14-year track record of the ARTISAN(TM) lens use in Europe, we are confident that our innovative Phakic IOL technology paired with Allergan's leadership in the ophthalmic surgical market will create a winning combination in North America and worldwide."

About Phakic IOLs

One of the oldest procedures in refractive surgery, Phakic IOL implantation is viewed by many European surgeons as becoming a primary refractive treatment method for myopia, hyperopia and astigmatism. Originally used for the correction of aphakia following cataract surgery Cataract Surgery Definition

Cataract surgery is a procedure performed to remove a cloudy lens from the eye; usually an intraocular lens is implanted at the same time.
Purpose

The purpose of cataract surgery is to restore clear vision.
, lens implants in Europe have experienced a renewed level of interest, particularly for patients with high refractive errors.

"As the complications and limits associated with traditional refractive surgical techniques become evident, surgeons will be seeking new ways to provide patients with optimal refractive outcomes," said Roger Steinert M.D., Associate Clinical Professor, Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. . "Phakic IOLs open the door to exciting new possibilities for alternative refractive surgical methods. The ARTISAN(TM) lens has an outstanding clinical track record internationally, and promises to be the lens of choice for appropriate patients. I look forward to the potential it may bring in other approved markets."

Phakic IOLs are placed in either the posterior chamber or the anterior chamber of the eye. When placed in the posterior chamber, some Phakic IOLs can lead to cataract formation and chafing chafe  
v. chafed, chaf·ing, chafes

v.tr.
1. To wear away or irritate by rubbing.

2. To annoy; vex.

3. To warm by rubbing, as with the hands.

v.intr.
 of the iris pigment. The placement of certain Phakic IOLs in the anterior chamber has been associated with risks of pupil ovalization and epithelial decompensation decompensation /de·com·pen·sa·tion/ (de?kom-pen-sa´shun)
1. inability of the heart to maintain adequate circulation, marked by dyspnea, venous engorgement, and edema.

2.
.

With its unique iris fixation method, OPHTEC's Phakic IOL technology enables the lens to attach to the periphery of the iris in a way that does not inhibit the iris' function. Securely anchored, the lens vaults forward, occupying the space between the crystalline lens Lens (or crystalline lens)
The eye structure behind the iris and pupil that helps focus light on the retina.

Mentioned in: Presbyopia
 and the corneal endothelium and provides for the free flow of aqueous from the posterior to the anterior chamber. This type of anterior placement minimizes the risk of endothelial endothelial /en·do·the·li·al/ (-the´le-al) pertaining to or made up of endothelium.
Endothelial
A layer of cells that lines the inside of certain body cavities, for example, blood vessels.
 cell loss, as well as cataract formation associated with crystalline lens trauma.

The ARTISAN(TM) lens was designed by Professor Jan Worst, M.D. and first introduced in 1978 for the correction of aphakia following cataract surgery. Its design was modified in 1986 to be used in the phakic eye pha·kic eye
n.
An eye containing the natural lens.
. Available in negative and positive powers, the lenses are manufactured from Perspex CQ-UV, polymethylmethacrylate (PMMA PMMA polymethyl methacrylate. ).

"Since 1996 I have implanted over 500 ARTISAN(TM) lenses including friends and members of my family. The degree of satisfaction of my patients is very high," said Dr. Raimund Sprig, St. Gallen, Switzerland. Dr. Nico H. Trap from the Netherlands commented that "the ARTISAN(TM) Phakic IOL is not only a reliable companion in the art of refractive surgery, but in addition to that, adjustable and/or reversible."

About OPHTEC

Founded in 1983 in Groningen, the Netherlands, OPHTEC BV is a medical device manufacturer that provides high quality ophthalmic implants, and a complete line of ophthalmic surgical devices for cataract, refractive, and trauma surgery. Privately held, the company distributes products worldwide. In 1997, OPHTEC USA, Inc. (Boca Raton, FL) was founded for marketing, selling, and distributing the products in the USA, Canada, Mexico, Central America, and Caribbean countries.

About Allergan

Allergan, Inc., headquartered in Irvine, California, is a technology-driven, global healthcare company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care pharmaceutical, ophthalmic surgical device, over-the-counter contact lens care, movement disorder, and dermatological markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives.

Allergan's current line of IOLs and implantation devices include the groundbreaking ARRAY(R) Multifocal IOL, the CLARIFLEX(TM) IOL with OptiEdge, the SENSAR(R) Acrylic IOL with OptiEdge(TM), the PHACOFLEX(R) II family of monofocal IOLs and The UNFOLDER(TM) Implantation Systems.

In addition to its expanding portfolio of IOL products, Allergan offers a full spectrum of equipment to meet ophthalmic surgeons' needs including the SOVEREIGN(R) and DIPLOMAX(R) phacoemulsification phacoemulsification /phaco·emul·si·fi·ca·tion/ (-e-mul?si-fi-ka´shun) a method of cataract extraction in which the lens is fragmented by ultrasonic vibrations and simultaneously irrigated and aspirated.  systems. An industry leader, Allergan was the first major global supplier of foldable IOL technology. Allergan Surgical holds a 14-year record of safety with its innovative IOL, phacoemulsification, and implantation technology.

Forward-Looking Statements

This press release contains "forward-looking" statements that are based on current expectations of future events such as statements regarding the projected product launch, safety and efficacy, and growth prospects. If underlying assumptions prove inaccurate or if unknown risks or uncertainties materialize, actual results could vary from the company's projections. Risks and uncertainties include substantial uncertainty associated with the regulatory approval process for the products, general domestic and international economic conditions; technological advances and patents attained by competitors; challenges inherent in new product marketing such as the unpredictability of market acceptance for a new product; potential difficulties in manufacturing a new product; domestic and foreign healthcare reforms; trends toward managed care and healthcare cost containment; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan as well as in Allergan's public periodic filings with the Securities and Exchange Commission, including "Certain Factors and Trends Affecting Allergan and Its Businesses" in Allergan's 2000 Annual Report on Form 10-K and Form 10-Q for the quarter ended September 28, 2001. Allergan's filings are available publicly and upon request from Allergan's Investor Relations Department, 714-246-4636, or from http://www.allergan.com.

Note to Editors: CLARIFLEX(TM), UNFOLDER(TM), SENSAR(R), ARRAY(R), DIPLOMAX(R), PHACOFLEX(R) and SOVEREIGN(R) marks owned by Allergan, Inc. ARTISAN(TM) mark owned by OPHTEC BV.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jan 16, 2002
Words:1283
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