Irvine, CA, March 22, 2004 - Ophthalmic device manufacturer Refractec Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted approval of the ViewPoint CK System for performing the NearVision CK (Conductive Keratoplasty) procedure. It is the first and only FDA-approved vision technology that improves near vision in the millions of Baby Boomers with presbyopia, the age-related eye condition that sets in after age 40. NearVision CK uses radio waves to reshape the cornea and bring near vision back into focus. Minimally invasive and painless, NearVision CK is performed in less than three minutes in the doctor's office with only eye-drop anesthesia. The procedure is laser-free and extremely safe; there is no cutting and no removal of tissue.

The Greek word for "aging eye," presbyopia is the most prevalent eye condition in America, affecting most people after age 40 and everyone by age 51. Presbyopia causes near vision to fade with age, making it difficult to see things up-close. An estimated 90 million Baby Boomers either have presbyopia or will develop the condition in the next 10 years. These people struggle to read or do hobby work and must rely on magnifying reading glasses for even the most mundane of daily tasks, like checking their watch. They often own multiple pairs of reading glasses (called "readers," "half-eyes" or "granny glasses"), which many consider a hassle and an unwelcome sign of aging.

"Presbyopia is the one inescapable vision disorder that will eventually affect us all," said Daniel S. Durrie, M.D. associate clinical professor, University of Kansas and medical monitor for the FDA clinical trial of presbyopia. "The frustration many people feel with the on-again, off-again annoyance of reading glasses cannot be overemphasized. NearVision CK is just what Baby Boomers have been waiting for to help them get rid of their reading glasses and safely see like they did when they were young."

Procedure Custom-Made For Baby Boomers

NearVision CK is the only vision procedure designed specifically for Baby Boomers who want a safe, minimally invasive procedure to free them of reading glasses. CK has become the fastest-growing new refractive procedure since the introduction of LASIK according to research firm Market Scope. More than 30,000 CK procedures have been performed since the FDA first approved it in 2002 for age-related farsightedness (hyperopia), a condition that differs from presbyopia in its effect on the eye's ability to focus, but has similar symptoms.

The FDA based its approval on clinical trial data collected at the 12-month follow-up visit in which NearVision CK demonstrated effectiveness in significantly improving patients' near vision.

• 98 percent of patients could see J5 (magazine- and newspaper-size print) in the eye that was treated
  
• 87 percent of patients could see 20/20 in the distance and also read J3 or phonebook-sized print (significantly smaller than news print).
  
• There were NO reported serious, sight-threatening or unanticipated safety events.

"During the clinical trials, everyone we treated had an improvement in near vision," said Marguerite B. McDonald, M.D., clinical professor of ophthalmology at Tulane University, director of the Southern Vision Institute, New Orleans, La., and medical monitor for Refractec, Inc. "Doctors and patients alike are excited about the safety and simplicity of the procedure. NearVision CK has the potential to expand the refractive market and for the first time, help millions of Americans improve their near vision."

About NearVision CK
NearVision CK is performed using a probe thinner than a strand of hair that releases radiofrequency energy. Applied to the cornea in a circular pattern, the radio waves shrink small areas of collagen to create a constrictive band (like the tightening of a belt) that increases the curvature of the cornea, bringing near vision back into focus.

NearVision CK is indicated for the temporary improvement of near vision in emmetropic presbyopes (those who require only reading glasses) and hyperopic presbyopes (those who require reading and distance glasses). The procedure is typically performed on just one eye, improving near vision without compromising the patient's binocular distance vision.


About Refractec
Refractec Inc. is a privately held ophthalmic company that develops and markets new ways for ophthalmologists to effectively treat refractive errors with its proprietary Conductive Keratoplasty (CK) technology. Refractec is "Reshaping Vision Correction?" and changing patient outcomes. The company is headquartered at 5 Jenner, Suite 150, Irvine, Calif.