FDA Panel Backs Staar’s Lens Implant
A Food and Drug Administration advisory panel Friday recommended approval of Staar Surgical Co.’s surgically implanted contact lens, moving the Monrovia company another step closer to bringing the product to the U.S. market.
Staar executives will have to wait until Monday to gauge the reaction of investors. Aware that the panel’s decision would be pivotal, Nasdaq and the company agreed to suspend trading of its shares Friday.
Staar shares closed Thursday at $11.94, up $1.21. The stock has soared 224% this year, boosted in part by a study in May that showed that the lens was a credible alternative to laser surgery in correcting nearsightedness.
If the product is approved by the FDA, it would be the first surgically implanted lens cleared in the U.S. for the treatment of myopia. The lens was approved for use in Europe in 1997.
The FDA advisory panel recommended approval by an 8-3 vote, but there were significant reservations. The panel said there should be at least five years of follow-up studies on patients as a condition of approval.
John Bily, Staar’s chief financial officer, said there were at least 100,000 potential patients in the U.S. He said the product can be removed if the patient is not satisfied.
