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FDA Approves EVO Visian Implantable Collamer Lens for Myopia

Over 1 million EVO lenses have been implanted by doctors outside the U.S.

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LAKE FOREST, CA — STAAR Surgical Co. announced that the U.S. Food and Drug Administration has granted approval of the EVO/EVO+ Visian Implantable Collamer Lens for the correction of myopia and myopia with astigmatism.

“Following FDA approval, prospective patients in the U.S. and their doctors may now consider EVO for achieving Visual Freedom from the limitations, ongoing maintenance and inconvenience associated with glasses and contact lenses,” said Caren Mason, president and CEO of STAAR Surgical.

Over 1 million EVO lenses have already been implanted by doctors outside the U.S., Mason said, adding: “The EVO lens is additive, provides excellent quality of vision day and night, does not cause dry eye syndrome and is removable by a doctor, if ever so desired.

EVOs are implanted within the posterior chamber of the eye directly behind the iris and in front of the natural crystalline lens, the company (NASDAQ: STAA) explained in a press release.

An estimated 100 million U.S. adults ages 21 to 45 who have myopia are potential candidates for EVO, a biocompatible implantable lens that corrects distance vision, STAAR Surgical stated.

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More from the release:

Earlier versions of the Visian ICL lens in the U.S. required a preoperative peripheral iridotomy that is now eliminated with EVO, thereby optimizing patient comfort and time efficiency for both the surgeon and the patient. EVO offers a lens-based alternative for the correction/reduction of refractive error in people who currently use glasses and/or contact lenses for distance vision correction. A U.S. multicenter, prospective clinical investigation confirmed the safety of the EVO family of myopia lenses. There are now more than 100 clinical papers available discussing the safety and efficacy of the Visian ICL family of lenses globally.

Scott D. Barnes, MD, Chief Medical Officer of STAAR Surgical, stated, “We are thrilled to make EVO available to U.S. surgeons and patients seeking a proven and premium option to glasses, contact lenses or laser vision correction. Today’s announcement is especially important because the prevalence of myopia is increasing quickly, and COVID precautions have presented additional challenges to people wearing glasses and/or contact lenses. EVO adds an important tool for the ophthalmic surgeon seeking to help improve a patient’s quality of life. Different from LASIK, the EVO lens is added to the patient’s eye through a relatively quick surgical procedure where there is no removal of corneal tissue. Moreover, the EVO lens is removable by a doctor if ever desired. Results from our recent U.S. clinical trial are consistent with the more than one million EVO lenses that have already been implanted around the world.”

EVO Visian ICL (Implantable Collamer Lens) is indicated for use in phakic eye treatment in patients 21–45 years of age:

-for the correction/reduction of myopia in patients with spherical equivalent ranging from -3.0 D to -20.0 D at the spectacle plane;

-for the correction/reduction of myopic astigmatism in patients with spherical equivalent ranging from -3.0 D to -20.0 D with cylinder of 1.0 D to 4.0 D at the spectacle plane;

-with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens;

-and a stable refractive history (within 0.5 D for 1 year prior to implantation).

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