STAAR Surgical EVO Lens Receives Green Light from the FDA

Mar 28, 2022 By MarketDepth

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close up eye

STAAR Surgical Company (NASDAQ: STAA) today announced that the U.S. Food and Drug Administration (FDA) approved the EVO/EVO+ Visian® Implantable Collamer® Lens (“EVO”) for the correction of myopia and myopia with astigmatism.

Stock Gains Premarket

Shares of STAAR Surgical Company (NASDAQ: STAA) gained over 14% in premarket trading following the announcement.

Over 1Million Lenses Implanted

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, according to the Company’s press release. “Over one million EVO lenses have already been implanted by doctors outside the U.S. and 99.4% of EVO patients in a survey have stated they would have the procedure again,” said Caren Mason, President and CEO of STAAR Surgical.

Implanted in The Posterior of Eye

EVOs are implanted within the posterior chamber of the eye directly behind the iris and in front of the natural crystalline lens, and there are more than 100 clinical papers available discussing the safety and efficacy of the Visian ICL family of lenses globally.

“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.”

Scott D. Barnes, MD, Chief Medical Officer of STAAR Surgical

Commercialization of EVO is expected to begin immediately in the U.S. and, according to  President and CEO of STAAR Surgical, Caren Mason, “Surgeons will be trained and certified for EVO, and begin implanting EVO in the coming days and weeks in select cities.”