WASHINGTON (dpa-AFX) - STAAR Surgical Company (STAA) said the FDA has informed the company that STAAR has provided sufficient data to support initiation of a human clinical study of the EVO/EVO+ VISIAN Implantable Collamer Lens for Myopia, and EVO/EVO+ VISIAN Toric Implantable Collamer Lens for Myopia with Astigmatism. In the letter dated August 23, 2019, FDA recommended study design modifications.
'STAAR looks forward to working with FDA to incorporate the recommended protocol modifications in order for the study design to support a marketing approval submission,' said Caren Mason, President & CEO.
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