Staar Soars on OK of Eye Implant

Shares of Staar Surgical Co. surged 47% on Friday after the company said it had received Food and Drug Administration approval to market its implantable contact lens to treat severe nearsightedness.

The Monrovia-based company, which makes various devices used in vision surgeries, said the foldable lens was the only one of its kind and required an incision half the size needed by other implantable lenses.

The company expects to begin shipping its new Visian ICL lens within eight weeks.

Joanne Wuensch, an analyst with Harris Nesbitt Corp. in New York, said the company had “a lot to celebrate.” The market for implantable lenses is “not particularly large, but it can be lucrative,” she said.

Staar’s stock jumped Friday to a 52-week high of $8.63 before closing at $8.51, up $2.74. Before Friday, the stock was down 8% for the year.

David Bailey, Staar’s chief executive, said in a statement that the implantable lens was the company’s “most significant opportunity for profitable growth.”

The device is also approved for sale in 41 countries in addition to the U.S.

The FDA action was a rare piece of good news for Staar, which has had a raft of problems in recent years -- including a struggle to win approval of its implantable lens.

Two years ago, an FDA panel expressed concern about complications associated with the lens. And last year, federal inspectors cited dozens of manufacturing, quality control and other problems at Staar’s Monrovia plant that slowed the approval process.

The FDA has had problems with other Staar products as well. The company recalled another lens four years ago because of a potential packaging flaw that could have compromised the product’s sterility.

And in March, Staar’s shares plummeted 22% the day it announced its outside accountants were doubtful about the company’s ability to stay in business.

Through the first nine months of this year, Staar posted a $7.8-million loss on sales of $39.2 million.

Last month the company warned that it would continue to post operating losses and suffer a negative cash flow until its new lens product was approved by the FDA and it generated significant sales. The various problems with the FDA have also hurt Staar’s sales and its reputation, the company acknowledged.

Despite the company’s difficulties, analyst Wuensch said she had maintained a “neutral” rating on Staar. After Friday’s stock price run-up, she said she was sticking with the rating.