Staar Surgical (Nasdaq:STAA) announced today that it received FDA approval for its Evo/Evo+ Visian implantable Collamer lens.
Lake Forest, California-based Staar Surgical designed the Evo biocompatible implantable lens for the correction of myopia and myopia with astigmatism.
More than 1 million Evo lenses have been implanted by doctors outside the U.S. to date, according to a news release. The lens, which represents a different option to Lasik, is added to a patient’s eye through a quick surgical procedure in which there is no removal of corneal tissue. The lens can be removed by a doctor if ever desired, too.
Evo lenses are implanted within the posterior chamber of the eye directly behind the iris and in front of the natural crystalline lens. FDA indication for use in phakic eye treatment covers patients between ages 21 and 45 years old with myopia/myopic astigmatism.
“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,” Staar Surgical CMO Dr. Scott D. Barnes said in the release. “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.”
BTIG analyst Ryan Zimmerman reiterated his previous position of “buy” for Staar Surgical and called the announcement “positive news” for the company.
“Through our own channel checks of US-based ICL clinics who participated in the EVO trial, we believe there are patients lined up waiting to receive the next-generation lens,” he wrote in a report. “Consistent with our upgrade thesis, we believe STAA can hit its US revenue numbers with just a proportion of incremental physicians this year.”