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FDA approves study of STAAR Surgical’s lenses for myopia, astigmatism

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The FDA has approved a human clinical study of the EVO/EVO+ Visian ICL for myopia and the EVO/EVO+ Visian toric ICL for myopia with astigmatism, STAAR Surgical announced in a press release.

The study will include 300 subjects with a primary endpoint at 6 months’ follow-up, the release said.

“STAAR looks forward to the next step in moving our trial forward, gaining institutional review board approval and initiating the EVO/EVO+ clinical trial as soon as possible, which we anticipate will be during the first quarter of calendar 2020,” Caren Mason, president and CEO of STAAR Surgical, said in the release.