FDA Panel Recommends Approval of CK System For Presbyopic Patients Who Need Near Vision Improvement

CK (Conductive Keratoplasty) To Be Sole Procedure For This Inevitable Condition That Affects Everyone Sometime After Age 40

Irvine, California, February 9, 2004 - Ophthalmic device manufacturer Refractec Inc.announced today that the U.S. Food and Drug Administration’s (FDA) Ophthalmic Devices Panel voted unanimously (11-0) late Friday to recommend approval of the Viewpoint™ CK System, used to perform the CK (Conductive Keratoplasty) procedure for the improvement of near vision in those who require only reading glasses (presbyopia) and those who require reading and distance glasses (hyperopic presbyopia). Presbyopia, commonly referred to as “aging eyes,” is the inevitablecondition that affects most people by the age of 40 and everyone by age 51, making it difficult to read, do hobby work or even see the time on a watch without aid of reading glasses.

The CK system is the first product ever reviewed by the FDA specifically for presbyopic patients who want to improve their near vision. The FDA first approved the CK system in 2002 for those over age 40 with farsightedness (hyperopia), a condition that differs from presbyopia in its effect on the eye’s ability to focus, but has similar symptoms.

Dr. Daniel Durrie of Overland Park, Kansas was the medical monitor of the clinical trials for CK. He has performed more than 50 percent of CK procedures worldwide. Dr. Durrie presented his clinical research data to the FDA panel. Two of his patients also testified in front of the panel. "This is a wonderful development for a huge segment of our population,” Dr. Durrie said. “The FDA panel decision validates what we’ve seen clinically regarding CK's success in treating thepresbyopic patient. "With approval, we will be allowed to inform the Baby Boomer population that there – finally – is a safe, simple treatment available just for them. It will be welcome news to the millions who are tired of the hassle and age-stigma associated with reading glasses."

CK has become the fastest-growing new refractive procedure since the introduction of LASIK, according to a comparison of historical data collected from research firm Market Scope and Refractec’s sales to date. CK is the only vision procedure designed specifically for people over age 40 and is perfect for the more risk-averse patient who’s been waiting for a safe procedure they consider easy to undergo.

CK is an extremely safe, non-laser vision procedure that is easy to undergo. There is no cutting and no removal of tissue during the three-minute procedure, which is done in the doctor’s office with only topical (eye drop) anesthesia. CK is performed using a probe as thin as a human hair that releases gentle radio waves, shrinking small amounts of collagen in the cornea, to improve patients’ near vision, without sacrificing their binocular distance vision.

An estimated 90 million people in the United States presently have presbyopia. The condition occurs when the lens of the eye loses flexibility making near vision, the ability to focus on objects up-close, more difficult. Patients affected by presbyopia often own multiple pairs of reading glasses and must rely on them for even the most mundane of daily tasks.

The panel’s recommendation was based on clinical 12-month follow-up data in which CK demonstrated effectiveness in significantly improving a patient’s near vision. 94 percent of patients could see J5 (magazine- and newspaper-size print) in the eye that was treated, and 83 percent of patients could see 20/20 and read J3 or phonebook-size print (significantly smaller than news print). There were NO reported serious, sight-threatening or unanticipated safety events.

"We’re very happy with the panel's unanimous decision and look forward to working with the FDA to finalize product labeling in the coming weeks, and to receiving full approval to market CK nationwide to Baby Boomers who are tired of their reading glasses," said Mitchell B. Campbell, president and CEO of Refractec Inc.

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