California ophthalmic devices maker STAAR Surgical (NSDQ:STAA) touted a pair of regulatory wins, landing a date with an FDA advisory panel and notching new Japanese market approval for its Visian Implantable Collamer Lens with CentraFLOW technology.
STAAR will meet next week with the FDA’s Ophthalmic Devices Panel to review the premarket approval application for the company’s Visian Toric ICL for treatment of myopic astigmatism. The original meeting, scheduled for February 14, was postponed over weather concerns.
Next week’s panel will discuss safety and efficacy data on the Visian Toric ICL, addressing FDA concerns about a series of deviations from the protocol for the study used to back the PMA bid.
The agency issued a warning letter in April 2004 after an inspection of a plant in Monrovia in December 2003 cited STAAR for "failure to obtain FDA approval prior to initiating a study, failure to ensure continuing Institutional Review Board (IRB) review and approval, failure to obtain signed Investigator Agreements from participating investigators, and failure to provide participating Clinical Investigators with all the information required to perform the study," according to the pre-meeting materials.
Survey: Will the FDA panel OK STAAR Surgical’s Toric ICL lens?
The FDA wants the advisory panel to consider whether there’s enough data to asses the safety and effectiveness of the Toric ICL implant. The FDA isn’t bound by the recommendations made by its advisory panels, but often follows their lead in its final decisions.
STAAR further notched Japanese regulatory approval for a new version of its Visian implant featuring CentraFLOW technology, which the company called a "key driver to our growth of Visian ICL revenues the past several quarters."
CentraFLOW allows physicians to treat a larger range of patients with the Visian ICL, expanding to myopia starting at -3.0 diopters, up from the current range at -5.0 diopters, according to a press release.
STAA shares closed last night at $14.30, up 1% on the day.
