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FDA will expedite review of phakic IOL

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BOCA RATON, Fla. — A phakic IOL currently under review at the Food and Drug Administration has been granted priority review by the regulatory agency, the lens’ marketers announced last week.

The phakic IOL is being manufactured and marketed by Ophtec as Artisan and by AMO as Verisyse, according to the joint press release. AMO is the exclusive distributor for this product in North America.

Because of the lens’ fixation method, “the lens vaults forward, occupying the space between the crystalline lens and the corneal endothelium and provides for the free flow of aqueous from the posterior to the anterior chamber,” according to the press release. The companies believe this type of anterior placement minimizes the risk of endothelial cell loss, “as well as cataract formation associated with crystalline lens trauma.”

The lens, already approved in Europe, is awaiting U.S. regulatory approval for the correction of myopia in phakic eyes in the range of –5 D to –20 D, the companies announced.