STAAR Surgical Company (STAA -20.9%) is down on modestly higher volume in early trade in reaction to its disclosure that the FDA has rejected its supplemental marketing application seeing approval for its EVO/EVO+ Visian Implantable Collamer Lens for myopia and EVO/EVO+ Visian Toric Implantable Collamer Lens for myopia with astigmatism.
The agency stated that the application was not complete enough to allow for review. Apparently, there were not enough data and analyses to prove safety and efficacy.
The company says it will continue its discussions with the regulator, including any new clinical data needed for a refiling.
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