To: pappy who wrote (395 ) 1/30/1998 9:33:00 AM From: johny Respond to of 1754
VISX First to Receive FDA Approval for Treatment of Higher Myopia With Astigmatism SANTA CLARA, Calif.--(BUSINESS WIRE)--Jan. 29, 1998--VISX Inc. (NASDAQ:VISX - news) announced today that the U.S. Food and Drug Administration (FDA) has approved the use of its excimer laser systems as safe and effective for the treatment of higher degrees of nearsightedness with astigmatism. VISX is the first and only laser manufacturer in the United States to receive such an approval. Greater than 99% of nearsighted consumers, with or without astigmatism, are now eligible for laser vision correction procedures using VISX excimer laser systems. ''We are extremely pleased with the FDA's expedited review for this indication,'' said David Patino, vice president of Regulatory and Clinical Affairs at VISX. He added, ''VISX continues to work diligently to expand the treatment parameters of the VISX STAR.'' Mark Logan, VISX chairman and chief executive officer, said, ''This is another step in our ongoing efforts to offer U.S. doctors and consumers the same range of procedures as their international counterparts. Not only is VISX the first and only company in the U.S. to receive approval for the treatment of low, moderate and high myopia with astigmatism, but we also expect to file for approval of hyperopia (farsightedness) in the first quarter. The broad beam and scanning capabilities of the advanced VISX STAR are proving invaluable as we move to have additional indications approved by the FDA.'' All VISX systems sold in the U.S. are capable of correcting the approved procedures via VISX's VisionKey(R) card. They will not have to use trackers, masks, additional hardware, or disposables, and a special service call is not required. VISX is the worldwide sales and technology leader in the dynamic laser vision correction market. Correction of astigmatism and/or low, moderate or high myopia using the VISX STAR generally takes less than one minute, requires no scalpel incisions and is incredibly precise. It is an automated, computer-controlled procedure that uses a cool beam of laser light to reshape the front surface of the cornea. Laser vision correction is the first FDA-approved innovation in refractive vision correction since the introduction of contact lenses in the 1950s. Another common form of vision correction using the excimer laser, LASIK, while not an approved FDA indication, is routinely performed by physicians on VISX systems as an ''off-label'' use and has been ruled a ''practice of medicine'' issue by the FDA.