Laser Eye Surgery, PRK, LASIK

LADARVision® System Receives FDA Approval for Farsightedness With Astigmatism Correction Using LASIK and for Mixed Astigmatism Using LASIK

FORT WORTH, Texas, Sept. 26 /PRNewswire/ The Alcon Summit Autonomous LADARVision® System is the first to win approval from the U.S. Food and Drug Administration to treat farsightedness (hyperopia) (less than or equal to +6.0 D), with or without astigmatism (less than or equal to -6.0 D) and for mixed astigmatism, using the LASIK procedure. The approval, which was announced Friday, September 22, gives LADARVision® the broadest range of approvals of any FDA-approved excimer laser and makes it the only one capable of treating all types of refractive errors with LASIK. Additionally, the LADARVision® system is the only FDA-approved laser system to combine laser radar eye tracking with small scanning spot technology during surgery.

The FDA granted expedited review to the company's filing because it represents a first for LASIK's use in hyperopia, hyperopic astigmatism and mixed astigmatism. The LADARVision® System is currently the only FDA-approved laser system to achieve these indications in a single procedure, minimizing the amount of tissue removed and eliminating potential risk of misalignment possible in second procedures.

"We've reached another milestone by becoming the first excimer laser manufacturer to gain approval for hyperopia with or without astigmatism, and for mixed astigmatism, using LASIK,"

said Charline Gauthier, O.D., Ph.D., vice president/general manager-Orlando operations.

"Approval for mixed astigmatism is of particular importance since it has recently been defined as a separate indication by the FDA and the LADARVision® System is the first excimer laser to demonstrate safety and effectiveness in treating it. Today, no competitor can claim a broader range of approvals."

Founded in 1985 and acquired by Alcon in 2000, Summit Autonomous Inc. is a leading developer, manufacturer and marketer of ophthalmic laser systems and related products designed to correct common vision disorders such as nearsightedness, farsightedness and astigmatism. In 1995, Summit Autonomous was the first to receive FDA approval for an excimer laser system for the correction of mild to moderate myopia in the U.S., and in 1999 became the first commercial excimer laser manufacturer to receive FDA approval for the popular LASIK procedure.

Alcon is the global leader in the research, development, manufacture and marketing of ophthalmic products, including surgical instruments and accessory products, intraocular lenses, prescription drugs and contact lens care solutions. The Alcon group is wholly owned by Nestle S.A.

Founded in Fort Worth, Texas in 1947, Alcon now employs more than 10,500 individuals around the world. Total sales for 1999 were $2.4 billion, with activity in more than 170 markets. One of the cornerstones of Alcon's success is the company's commitment to Research and development. Housed at the company's headquarters in Fort Worth is the 400,000 square-foot William C. Conner Research Center, the largest and most sophisticated eye research center in the world. Over the next five years, Alcon plans to spend more than $1 billion on eye-related research, more than any entity outside of the National Eye Institute.

Created September 29, 2000