Bei der Aufstellung meines Depots war die Entscheidung noch nicht raus - ich schwörs beim Barte des Propheten :-)
(zumindest hatte ich es noch nicht mitbekommen)
Ich wusste nur, dass sie anstand und habe mit einem positiven Bescheid der FDA gerechnet, da die Linsen in Europa schon verkauft werden dürfen.
Reuters
US panel urges approval for Staar implanted lens
Friday October 3, 8:16 pm ET
By Lisa Richwine
GAITHERSBURG, Md., Oct 3 (Reuters) - A U.S. advisory panel on Friday voted 8-3 to urge approval for Staar Surgical Co.'s (NasdaqNM:STAA - News) implantable lens to correct nearsightedness, a possible alternative to laser eye surgery.
If the Food and Drug Administration (News - Websites) agrees with the panel, which it usually does, the product would be the first implantable lens sold for people whose natural lenses are intact. Implanted lenses on the market now are used to replace lenses following cataract surgery.
Staar's product is a refractive lens that physicians inject through a small incision and place behind the iris. The company aims to market the procedure for people age 21 to 45 with moderate to severe nearsightedness, or myopia.
In a trial evaluating more than 500 eyes that had the lens implanted, 84 percent had vision of 20/40 or better one week after the procedure. Three years later, 81 percent had that level of vision, the company said.
Some patients experienced a gradual loss of cells in the cornea, an issue of concern to the panel. Some loss is normal, but panelists said they could not tell from the current research whether the loss would continue over time and damage the cornea.
The company argued the cell loss stabilized in three to four years, but the panel said the research did not prove that was the case.
"We don't know what's going to happen in 10, 20, 30 years," said Dr. Marian Macsai-Kaplan, a panel member and chief of ophthalmology at Evanston Northwestern Healthcare in Illinois.
The panel, by a 6-5 vote, urged the FDA to require Staar to monitor the cell loss annually for five years in certain patients who took part in the clinical trial. Some who dissented felt the long-term data should be collected before the device is allowed on the market.
The Staar lens would offer an alternative to the popular Lasik surgery, in which physicians use a laser to reshape the cornea and correct vision.
Staar calls its device an implantable contact lens. Panel member Timothy McMahon, professor of ophthalmology at the University of Illinois at Chicago College of Medicine, said that description was a "euphemism" that could mislead patients and should not be allowed.
Staar Chief Executive David Bailey said he was "delighted" with the panel outcome. "It's a first-of-a-kind (product), great technology. We're very pleased."
Bailey declined to discuss potential sales for the lens. The company previously has said it expects to reach profitability during the first half of next year if it wins a go-ahead to sell the lens in the United States. The lens already is sold in Europe and Asia.
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