Staar Surgical announced that the FDA, in a letter dated August 23, 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.
FDA also recommended study design modifications, which Staar plans to incorporate into the investigational plan in a revised submission in the coming month. Staar’s current plan for the study reflects FDA’s recommendations from ongoing interactive dialogue regarding the investigational protocol, including 300 subjects with a primary endpoint at 6 months follow up. Subjects enrolled in the trial will not undergo planned peripheral iridotomies.
“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,” Caren Mason, President & CEO, said in a company news release.
Finalizing the investigational device exemption (IDE) with the FDA is an important step towards the future availability of the EVO Visian ICL family of products in the United States.