Staar Surgical Announces FDA IDE Clinical Study Approval

Source: Staar Surgical

Staar Surgical announced that the FDA, in a letter dated December 6, 2019, stated that it has determined that Staar has provided sufficient data to support initiation of a human clinical study in the United States of the EVO/EVO+ VISIAN Implantable Collamer Lens for Myopia, and EVO/EVO+ VISIAN Toric Implantable Collamer Lens for Myopia with Astigmatism.

“Staar looks forward to the next step in moving our trial forward, gaining Institutional Review Board (IRB) 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 a company news release.

Initiating the clinical trial is an important step towards the future availability of the EVO Visian ICL family of products in the U.S. Staar’s plan for the study includes 300 subjects with a primary endpoint at 6 months follow-up.

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