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Home » FDA Oks Staar Surgical trial for Evo, Evo+ Visian lenses

FDA Oks Staar Surgical trial for Evo, Evo+ Visian lenses

August 27, 2019 By Sean Whooley

Staar SurgicalStaar Surgical (NSDQ:STAA) said today that the FDA approved a U.S. clinical trial of its Evo and Evo+ Visian lenses.

Monrovia, Calif.-based Staar’s Evo/Evo+ devices are implantable collamer lenses designed to treat myopia and myopia with astigmatism.

In May, the FDA’s Center for Devices & Radiological Health requested more data on the lenses, claiming Staar lacked the “clinical evidence and analysis” required for premarket approval.

In an Aug. 23 letter, the federal safety watchdog approved the company’s data and recommended study design modifications, which Staar plans to incorporate into its investigational plan. The company intends to include the plan in a revised submission set for the coming month, moving towards finalizing investigational device exemption with the FDA.

Staar’s current plan for the study includes 300 subjects with a primary endpoint at six months. Subjects enrolled in the trial will not undergo planned peripheral iridotomies, the company said in a release.

“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,” president & CEO Caren Mason said in prepared remarks.

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance Tagged With: STAAR Surgical Co

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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