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September 16, 2004

BehindTheMedspeak: Another eye operation to avoid - just approved by the FDA


Every time I read about the latest in corrective eye surgery for conditions which are perfectly amenable to treatment with glasses, I wince.

The reason I wince is because for every thousand people who are delighted to finally lose their glasses, there are a couple who are made functionally blind by the unfortunate results of these procedures.

But I guess when when you're getting a couple thousand dollars 10 times a day for a 30 minute procedure, and you do the math - (10 x $2,000 = $20,000/day, x 4 days a week [I mean, come on, if you're a real ophthalmologist, you've gotta be taking off at least one working day a week] = $80,000/week x 40 weeks a year [I mean, come on, if you're a real ophthalmologist, you've gotta be taking at least three months vacation a year] = $3,200,000/year - you figure that's an acceptable loss.

I mean, it's not your eye.

Barnaby J. Feder wrote about the latest novelty, the Ophtec implantable lens, which has been used in Europe for the past 17 years, in Tuesday's New York Times.


You might want to think about why, if it's so great, it took 17 years for Ophtec to finally get it approved for use in the U.S.

Lasik, of course, remains my poster-child when it comes to bad eye operations.
Now people who can't or won't get Lasik or contacts for near-sightedness have something else they can waste their money on.

You couldn't pay me to have one of these procedures.

Here's the story from the Times.


F.D.A. Approves Lens Implant That Corrects Nearsightedness

The Food and Drug Administration has cleared eye doctors to treat moderate to severe nearsightedness with an implantable corrective plastic lens, the developer of the product and its distributor said yesterday.

The Dutch-designed lens, which will be distributed in the United States by Advanced Medical Optics, based in Santa Ana, Calif., will be marketed primarily to middle-age Americans who are considered to be poor candidates for laser surgery to correct nearsightedness.

The lens approved yesterday is made by Ophtec, a Dutch company that has been selling it in Europe for 17 years. Advanced Medical will sell it under the name of Verisyse in the United States.

Known technically as a phakic intraocular lens, Verisyse is inserted through a six millimeter incision between the cornea and the iris.


The 30-minute procedure requires local anesthesia and patients can normally return to work the next day.

Staar Surgical, based in Monrovia, Calif., is seeking F.D.A. approval for a competing phakic lens that is inserted behind the iris in the same location where surgeons put synthetic lenses for cataract patients.

The F.D.A. has favorably reviewed Staar's lens but has not completed an audit of its manufacturing operations.

Advanced Medical declined to say how many doctors have been trained to use Verisyse or how quickly that number would expand.

But Peter Bye, an analyst who follows ophthalmology products for Smith Barney, estimated yesterday that 200 surgeons would be qualified to offer the implants by the end of this year.

Ophthalmologists who participated in the clinical trials are charging about $3,000 to $4,000 an eye for the implant, more than double the cost of laser surgery, a spokesman for the company, Steve Chesterman, said.

Laser surgery reshapes the eye's natural lens, known as the cornea, to focus light at the proper point for clear vision.

But surgeons generally do not perform the surgery on people with unusually thin corneas or very severe nearsightedness.

Mr. Chesterman said that two million to five million Americans a year might be candidates for the implants, but that Advanced Medical does not expect sales to expand rapidly enough to affect earnings this year or next.

Advanced Medical, which was spun out of Allergan in 2002 and offers a broad range of eye treatment devices and solutions, had $601.5 million in sales last year.

September 16, 2004 at 09:01 AM | Permalink


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