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FDA Approves Visx Laser for Vision-Correction Technique

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From Bloomberg News

Visx Inc. on Monday won Food and Drug Administration approval to market its eye lasers for the popular Lasik vision-correction technique used in the majority of laser eye surgeries.

With the approval, Visx, the leading maker of eye lasers, becomes the second company to win clearance to market a laser for the Lasik technique. Summit Technology Inc., the No. 2 firm, won FDA clearance for the new method last month.

Visx and Summit’s lasers have already received FDA approval for an earlier technique called PRK--photorefractive keratectomy--and were in wide use to perform Lasik without FDA approval. The approval isn’t likely to significantly expand the established market, said Theodore Huber, an analyst at Advent.

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Still, FDA endorsement of the Lasik technique eases restrictions on advertising the procedure and could lead to wider use. That could increase earnings for the manufacturers, who receive royalties from doctors for each procedure.

Visx shares rose $1.94 to close at $81, while Summit fell 6 cents to close at $20. Both trade on Nasdaq.

Santa Clara-based Visx has long been the leader in vision-correction lasers because the company had FDA approvals to treat the broadest cross-section of both nearsighted and farsighted patients. Summit has slowly caught up, and both are now approved to treat the same range of nearsighted patients.

Visx and Summit, based in Waltham, Mass., will be facing additional competition next year. LaserSight Inc. won approval for its vision-correction laser this month, and Bausch & Lomb Inc. is waiting for FDA approval of its laser.

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