FDA approves implanted lens to fix extreme nearsightedness

09.14.04
By Diedtra Henderson
The Associated Press

WASHINGTON - There's a new option for people with extreme nearsightedness: The first implantable lens to correct the condition was approved yesterday by the Food and Drug Administration.

A surgeon slips the lens through a small incision and implants it in front of the natural lens. Like a camera lens being swiveled into focus, the tiny, hard-plastic lens helps the eye see clearly.

An estimated 53 percent of Americans use contact lenses or eyeglasses to correct their vision.

The lens implant is designed to provide an alternative to glasses, contact lenses or Lasik surgery for people who have trouble seeing distant objects. The lens, already in use in Europe, is manufactured by Ophtec USA, of Boca Raton, Fla., under the trade name Artisan. It will be distributed by Advanced Medical Optics under the Verisyse brand name.

The lens "provides superior quality of vision, especially for individuals with high myopia," said Rick McCarley, president and chief executive officer of Ophtec USA.

The implant, which will cost $3,000 to $4,000 an eye, is targeted at patients who can't get Lasik, which costs an average of $1,785 an eye.

McCarley said the lens implant typically is not covered by health insurance because it is an elective procedure. "However," he said, "we have had some cases ... where the patients' visual acuity, or their level of myopia, was so bad that some insurance companies did work with them because it allowed a person who previously could not work ... to work."

"I think it's huge," said Dr. Robert Maloney, an ophthalmology associate professor at the University of California, Los Angeles. "It is huge in the same way Lasik was huge a decade ago."

Maloney, who has performed experimental implant procedures on nearly 100 patients since 1997, said the implantable lens is 50 percent more accurate than Lasik. "And it gives better quality of vision: The vision is crisper, brighter and clearer," he said.

After three years, 92 percent of 662 patients had 20/40 or better vision, considered standard vision necessary to obtain a driver's license, and 44 percent had 20/ 20 or better, the FDA said, citing Ophtec research. The implant was tested in people whose nearsightedness was moderate to severe.

However, the FDA said the lens implant may not eliminate the need for glasses for night driving or other activities performed in low light.

Others warn of the risk of patients developing cataracts or eye-destroying infections.

"Even though that is a very small risk ... that is significant," said Dr. Balamurali Ambati, an ophthalmologist and corneal specialist at the Medical College of Georgia. "Anytime the eye is opened, bacteria can get in."

Nicholas Tarantino, vice president of global clinical research and development for Advanced Medical Optics, said no patients in the U.S. clinical trials developed cataracts.

The FDA is requiring the company to do a follow-up, five-year study of users of the lens to determine any side effects.

One possible concern, the FDA said, is the loss of endothelial cells in the corneas of patients with the implants. These cells form a layer on the under surface of the cornea and are essential to keeping the cornea clear.

In the tests, there was a steady loss of endothelial cells of 1.8 percent a year. Officials said it is not known whether the loss will continue at the same rate or what the long-term effect of this device on the cornea might be. The FDA is requiring the lens label to specify it be used only in patients with a dense enough layer of these cells to stand some loss over time.