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Shares Rise 10% After FDA Approval of Implantable Lens
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STAAR Surgical Co. shares traded higher after the company reported that the U.S. FDA approved its EVO Visian® Implantable Collamer® Lenses to correct myopia (nearsightedness) and myopia with astigmatism.

Implantable eye lenses developer, manufacturer and marketer STAAR Surgical Company (STAA:NASDAQ), today announced that "the U.S. Food and Drug Administration (FDA) has granted approval of the EVO/EVO+ Visian® Implantable Collamer® Lens (EVO) for the correction of myopia and myopia with astigmatism."

The company noted that myopia, which is often referred to as nearsightedness, is the world's most prevalent vision disorder. The firm noted that in the U.S. there are approximately 100 million adults between the ages of 21 and 45 who have some level of myopia and are potential candidates for EVO, which the company describes as "a biocompatible implantable lens that corrects distance vision."

STAAR Surgical's President and CEO Caren Mason remarked, "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…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."

Mason continued noting, "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. Sales of EVO lenses outside the U.S. increased 51% in 2021 and have more than doubled since 2018, which speaks to the increasing choice by patients and our surgeon partners for EVO as the premium and primary solution for refractive vision correction."

According to Mason, the company intends to quickly train and certify surgeons on EVO specific implant techniques, specifications and protocols and commence the U.S. commercial rollout of EVO immediately beginning in select unnamed cities. In parallel, the firm plans to launch a nationwide advertising, marketing and PR campaign.

The company advised that its Implantable Collamer lenses have been widely available and utilized to improve patients' vision for over 20 years. The firm explained that "EVOs are implanted within the posterior chamber of the eye directly behind the iris and in front of the natural crystalline lens."

The company's Chief Medical Officer Scott D. Barnes, M.D. commented, "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."

"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," Dr. Barnes added.

STAAR Surgical designs, creates and manufactures implantable lenses for the eye and delivery systems that are utilized to surgically place the lenses into the eye to improve patient vision. The company advised that its lenses are engineered to allow patients to lessen or eliminate their need for, or reliance upon eyeglasses or contact lenses.

STAAR Surgical started the day with a market cap of around $3.5 billion with approximately 47.79 million shares outstanding and a short interest of about 4.8%. STAA shares opened 15% higher today at $83.88 (+$10.93, +14.98%) over yesterday's $72.95 closing price. The stock has traded today between $78.82 and $87.12 per share and closed for trading at $80.70 (+$7.75, +10.62%).


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