Lake Forest, Calif.-based Staar Surgical’s Evo, Evo+ and Visian lenses all earned the European approval. The Evo/Evo+ and Visian devices are implantable collamer lenses designed to treat myopia and myopia with astigmatism, while the three are also produced as toric implantable Collamer lenses for myopia and hyperopia with astigmatism.
“The ICL’s new CE Mark approval expands the indications for the Evo Visian ICL product family to include a much-needed therapeutic option for the population of post-surgery cataract patients that find themselves back in glasses or contact lenses,” Staar Surgical president & CEO Caren Mason said in a news release. “This new approval demonstrates the safety, versatility and significant market opportunity for our Evo ICL family of lenses and supports those surgeons who are actively building lens-based practices.”
“Evo ICL, implanted as a supplemental lens, offers an important safety net for a cataract patient’s vision and provides the opportunity for excellent uncorrected visual acuity and a spectacle-free lifestyle,” added Mark Packer MD Consulting president and ophthalmologist Dr. Mark Packer. “Multiple authors of peer-reviewed, scientific publications have already reported successful deployment of the Evo ICL as a supplemental lens for the correction of residual refractive error following cataract surgery. … Regulatory approval of the Evo ICL family of lenses for use as a supplemental lens will now provide surgeons with greater confidence to use this critical tool to help patients who are dissatisfied with residual refractive error after cataract surgery.”
The ICL family has not yet earned FDA approval, but the agency did approve a clinical trial for the lenses in August 2019. The 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, according to a news release.
Previously, 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.