What This FDA Approval Means for STAAR Surgical

Health and Healthcare

Published: September 14, 2018 10:10 am

Last Updated: January 11, 2020 5:54 pm

STAAR Surgical Co. (NASDAQ: STAA) shares made a handy gain on Friday after the firm announced a key approval by the U.S. Food and Drug Administration (FDA).

The FDA granted the approval of the PMA Supplement for the Visian Toric Implantable Collamer Lens (ICL) for the correction of myopia with astigmatism.

Overall, this approval represents a meaningful expansion of the ICL product line for the correction of refractive error in patients with both myopia and astigmatism, which are common conditions in the United States. Astigmatism affects roughly 30% of the population.

Patients have described ICL surgery as “life-changing” or wished they had opted for the surgery sooner. The ICL in both spherical and toric designs has been associated with significant improvements in quality of life. The approval of the Visian Toric ICL is also an important step toward the future availability of advanced ICL models in the United States, such as the EVO/EVO+ Toric ICL.

Caren Mason, president and CEO, commented:

FDA’s approval of STAAR’s Visian Toric ICL in the U.S. provides an exciting treatment option for myopic patients with astigmatism in search of visual freedom. We are thrilled to be able to offer this lens in the United States and look forward to officially making the Visian Toric ICL available to U.S. surgeons for their patients on November 1st, 2018.

Shares of STAAR were last seen up about 3% at $52.15, with a consensus analyst price target of $49.00 and a 52-week range of $10.75 to $51.40.

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