Staar Surgical Gains Supplemental Lens Approval for EVO Visian ICL

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LAKE FOREST, Calif.—Staar Surgical (NASDAQ: STAA) announced that it has gained CE Mark approval for use of its ICL as a supplemental or “piggyback” lens in post-cataract IOL surgery patients (pseudophakics). A supplemental EVO ICL is placed in front of the cataract IOL lens in post-cataract patients just like the EVO ICL is placed in front of the human crystalline lens in refractive patients. The EVO ICL in the post-cataract patient is supplemental to the cataract IOL. The approval is for Staar’s EVO/EVO+ and Visian Implantable Collamer Lenses for myopia and hyperopia, and EVO/EVO+ and Visian 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,” said Caren Mason, president and CEO of Staar Surgical. “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.”

Approximately 28 million eyes undergo cataract surgery each year globally, according to Market Scope, an independent health care data market research firm. Data from the European Registry of Quality Outcomes for Cataract and Refractive Surgery suggest that at least 13 percent of cataract patients have significant residual postoperative refractive error that may be corrected. Additional data suggests that up to 21 percent of patients with a history of corneal refractive surgery, including prior LASIK or RK, may need an enhancement procedure to achieve acceptable vision without eyeglasses or disposable contact lenses.

“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,” said ophthalmologist Mark Packer, MD, president of Mark Packer MD Consulting.

Globally, an estimated 131 million eyes had cataract surgery for the five-year period from 2015 through 2019, according to Market Scope.