May 27, 2003

HEALTH

Visx Wins FDA Approval For New Laser Eye Surgery

By DON CLARK
Staff Reporter of THE WALL STREET JOURNAL

Visx Inc. won government approval for a new and more precise laser vision-correction procedure.

The Santa Clara, Calif., company is the second firm to be approved by the U.S. Food and Drug Administration for what is called wavefront-guided laser surgery, which has been shown to give patients consistently better vision and reduced side effects than earlier techniques. Alcon Inc., a company based in Hunenberg, Switzerland, received FDA approval in October.

Laser surgery reshapes the cornea to treat near-sightedness and other conditions. The most popular technique is called Lasik, short for laser-assisted in situ keratomileusis. Though many patients have seen major benefits, some have complained of blurred night vision or other side effects.

The new procedure, sometimes called custom Lasik, creates precise, individualized measurements of imperfections in a patient's eye before beginning corrections. Visx said its CustomVue technology has been used in 351 procedures; clinical data showed that 98% of patients could see 20/20 or better after the surgery, and most said their night vision had improved.

"It's a very exciting result," said Liz Davila, the company's chairman and chief executive officer. "We've been waiting a long time for this."

Ms. Davila noted that Visx is the first company to receive FDA approval to correct both near-sightedness and astigmatism, a common ailment that blurs part of the field of vision because of an irregularity in the curvature of the cornea.

The new procedure works with the company's existing laser equipment, which is used in a large number of vision clinics in the U.S. and abroad. Doctors must buy additional diagnostic equipment, for about $65,000, and access free software that enables the laser to carry out the customized procedure

Visx gets most of its revenue from per-procedure fees. It hasn't spelled out its new pricing, but Ms. Davila said it will be about double the $100 per eye Visx gets for the Lasik procedure. The added revenue should begin rolling in soon, with the first systems expected to be in place in the next few weeks, Ms. Davila said. She said doctors are expected to at least pass along the cost of Visx's added fees to the current price of treatment, which ranges anywhere from $700 to $2,500 per eye.

Visx released news of the FDA approval Friday afternoon, following an annual shareholder's meeting that brought another piece of good news. Stockholders elected a slate of directors proposed by company management and rejected a nominee proposed by investor Carl Icahn, who is part of a group that has urged the company to seek a buyer. Visx recently agreed to amend a defense against hostile takeovers that Mr. Icahn opposed.

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