Implantable lens for nearsightedness wins US OK

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U.S. regulators on Monday approved an implantable contact lens that corrects nearsightedness and offers an alternative to laser surgery.

The U.S. Food and Drug Administration approved the tiny Verisyse lens, made by Netherlands-based Ophtec BV and its U.S. affiliate, for use in people with “healthy eyes” and “stable vision.”

In a statement, privately held Ophtec said the device will be marketed to nearsighted patients who may not be good candidates for laser surgery.

The lens should not be used in people who have more than a minor astigmatism, a vision disorder caused by an uneven curve of the cornea, the FDA said.

The implant is smaller than a contact lens and similar to those used to treat cataracts, but it does not replace the eye’s natural lens. It is inserted via a small incision and is centered over the pupil between the cornea and iris.

“Unlike laser surgery, implantation ... involves no removal of tissue, and the lens can be easily removed at any time in the future,” said Rick McCarley, president and chief executive officer of Ophtec’s U.S. unit.

The FDA said it is not certain how well a patient would be able to see after the lens was surgically removed. FDA officials also warned that lens could cause the loss of certain cells in the cornea.

The agency said Ophtec must study the device for five more years to monitor eye problems, including cataract development and detachment of the retina.

Implantation of the lens can also cause swelling of the cornea, a company study of 662 patients showed.

“At this point, it is not known whether this (cell) loss will continue at the same rate, or what the long-term effect of this device on the cornea’s health might be,” the FDA said.

Ophtec’s three-year clinical trial of patients with moderate to severe nearsightedness found vision improved to 20/40 or better in 92 percent of those studied, while 44 percent had 20/20 vision or better.

Ophtec’s U.S. affiliate, Advanced Medical Optics, a medical device maker based in Santa Ana, California, will distribute the device in the United States. The lens is already marketed under the name Artisan in other countries.

Staar Surgical Co. is also seeking FDA approval for a similar device. Officials for the Monrovia, California company have said they expect to launch their lens during the fourth quarter of 2004.

Shares of Staar were up 6.4 percent at $5.90 in early Monday afternoon trading on the Nasdaq. Advanced Medical Optics shares were down 1.1 percent at $38.82 on the New York Stock Exchange.

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