Shares of Staar Surgical Co. fell Tuesday after the ophthalmic product maker said that federal regulators are unlikely to approve its new implantable lens this year.
The U.S. Food and Drug Administration told the Monrovia-based company last week that because the company's Visian TICL, which treats both nearsightedness and astigmatism, was a first-of-its-kind device it must first be submitted to a special ophthalmic devices panel for evaluation.
Staar had submitted the TICL to regulators as a supplemental application to the company's original Visian ICl lens, which the FDA approved in 2005, and was expecting a quicker decision, the company said in a statement.
Shares of Staar fell 3 cents to $6.76 in after hours trading, after closing down 11 cents to $6.79 on the Nasdaq Stock Market.
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