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.