Shares of Staar Surgical Co. soared more than 47 percent Friday after the surgical products maker said U.S. health regulators approved its Myopic Visian ICL lens for use in the correction of nearsightedness in adults.
The U.S. Food and Drug Administration's approval came after the agency had held up approval of the Swiss-made lens for more than a year over concerns about manufacturing flaws with the product itself and unrelated problems at a Staar manufacturing plant in Monrovia.
Staar rose 47.5 percent to settle at $8.51 on Friday after having dropped to as low as $3.12 in July.
The company's implantable collamer lens' foldable design allows an incision up to 50 percent smaller than competing technology, according to the company. A Dutch-developed implantable lens from Santa Ana-based Advanced Medical Optics won FDA approval last year.
The ICL already is approved for sale in 41 countries, including the European Union, and has been implanted in more than 40,000 eyes worldwide, leading to a 38 percent revenue increase so far this year. Staar has posted losses for the past five years.
"The ICL remains our most significant opportunity for profitable growth going forward and receipt of FDA approval represents a critical milestone," David Bailey, Staar's chief executive, said in a statement.
Analyst Kate Sharadin at Pacific Growth Equities said she'll be revisiting her $4.5 million revenue estimate for 2006, believing it now is too conservative.
Staar expects to begin shipping the Visian in six to eight weeks. Doctors must be trained and certified to use the lens, and Staar said more than 860 surgeons have completed the first phase of training.
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