FDA Panel Backs Staar ProductMonday, March 17, 2014
Shares of Staar Surgical Co. jumped 15 percent on Monday after the lens company announced that a Food and Drug Administration advisory panel had recommended U.S. marketing approval for an implantable eye lens.
The independent panel met Friday to review clinical data for the Monrovia company’s second implantable lens, which is already available in 60 other countries.
The company already has an implantable lens on the U.S. market for patients with nearsightedness; this would be its second. The company is putting the second lens on the market for nearsighted patients with astigmatism.
The FDA generally follows the recommendations of its expert advisory panels, and full regulatory approval for the lens could come in the second half of this year.
Staar Surgical gained its first approval for the lens in 2001 outside the United States, but its 2006 application for U.S. approval ran into roadblocks when the agency questioned some of the clinical trial results.
Staar shares closed up $2.33, or 15 percent, to $17.17 on the Nasdaq.