Shares of troubled Staar Surgical Co. soared 36.4 percent following news Friday that the Federal and Drug Administration determined the company's implantable contact lens is in line for approval.
The FDA still has to inspect the Monrovia-based ophthalmic devices maker's facilities to ensure compliance with quality control regulations. The company has stumbled for more than a year with quality control problems that have slowed approval of the implantable lens. Most recently, the agency warned the company on July 5 that it was facing possible sanctions because of its inability to correct various problems.
The implantable lens is placed in front of a patient's natural lens and can correct both nearsightedness and farsightedness. Staar is counting on domestic sales of the lens to offset the company's loss of market share in its cataract product lines.
The lens has been approved for sale in 40 countries and has been implanted in approximately 40,000 eyes, according to Staar's Securities and Exchange Commission regulatory filings. The company started selling the product commercially in 1996 and it is approved for sale in the Europe Union.
Staar's shares rose $1.41 to close at $5.38 Friday on the news.
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