|Staar Surgical's Visian Toric ICL--Courtesy of Staar|
Staar Surgical ($STAA) cleared a major obstacle that should boost the chances for FDA approval of its new lens implant. On Friday, the regulatory agency's Ophthalmic Devices Panel essentially endorsed the product, determining that it is safe and effective for the proposed indication, and that its benefits outweigh any risks.
The FDA doesn't have to follow the recommendations of the panel of experts, but typically does when it makes a final approval decision. And so the Visian Toric Implantable Collamer Lens has a clear shot of reaching the regulatory finish line.
Staar, based in Monrovia, CA, is seeking approval to use the Visian Toric ICL to treat myopia and astigmatism. The refractive, phakic implant is a variation of the company's Visian ICL, which has had U.S. approval since 2005 to treat myopia. FDA approval will be a big deal, because the U.S. market lacks a phakic implantable lens to correct astigmatism. The Visian Toric ICL is implanted in the posterior chamber of the eye between the iris and natural crystalline lens.
Staar President and CEO Barry Caldwell noted in a statement that the panel considered data from a trial study that was more than 10 years old, and that the FDA, panel members and Staar presenters spent an enormous amount of time preparing for this panel session. The Staar Toric ICL trial included data from 210 eyes in 124 patients, and 12-month clinical outcomes showed 82% of the eyes post-surgery achieved 20/20 vision or better without correction, and that 54% of the eyes achieved 20/16 or better, according to the company.
"The Staar team looks forward to working with the FDA to complete the process to make the Visian Toric ICL available to surgeons and patients in the U.S.," Caldwell said in a statement.
Staar booked $18.9 million in revenue for the quarter ending Jan. 3, 2014, versus $16.5 million a year ago, with more than half coming from Visian ICL product sales.
- read the release
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