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FDA agrees to expedited review of Staar’s ICL

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The Food and Drug Administration has granted an expedited review status to Staar Surgical’s implantable contact lens. Upon notifying the company of its decision, the FDA noted “the Collamer Implantable Contact Lens for myopia may provide a clinically meaningful advantage over existing technology in terms of increased effectiveness for patients with high myopia.”

Staar’s ICL is a phakic refractive lens that provides treatment for myopia, hyperopia and astigmatism. The company’s current U.S. submission is for the correction of myopia from –3 D to –20 D.

“We have always asserted that the ICL would represent the next paradigm shift in refractive surgery and consider the granting of expedited review status by the FDA an underscore of this belief,” said David Bailey, president and chief executive officer of Staar.

The ICL is approved for sale in 37 countries and has been implanted in more than 30,000 eyes worldwide, according to the company.