STAAR Surgical Company (NASDAQ:STAA) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On May 2, 2019, the Company received a letter dated May 2, 2019 from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA).The FDA advised the Company it had completed an initial scientific review of the Companys premarket approval application (PMA) supplement regarding EVO/EVO+ Visian Implantable Collamer Lens for Myopia and EVO/EVO+ Visian Toric Implantable Collamer Lens for Myopia with Astigmatism. The FDA advised the Company that its PMA supplement lacked information, particularly the clinical evidence and analysis, that would permit the completion of the review and determination of whether there is a reasonable assurance of the devices safety and effectiveness for its intended use. The Company expects to continue discussions with the FDA, including discussing the FDAs concerns with the existing PMA supplement and any new clinical data that may be required.
About STAAR Surgical Company (NASDAQ:STAA)
STAAR Surgical Company designs, develops, manufactures and sells implantable lenses for the eye and delivery systems used to deliver the lenses into the eye. The Company operates in the ophthalmic surgical market segment. Its principal products are intraocular lenses (IOLs) used in cataract surgery and implantable collamer lenses (ICLs) used in refractive surgery. It makes lenses used across the world in corrective or refractive surgery, and makes lenses for use in surgery that treats cataracts. Its refractive surgery corrects the types of visual disorders that glasses or contact lenses have treated (myopia, hyperopia, astigmatism and presbyopia). Its refractive surgery corrects the types of visual disorders that glasses or contact lenses have treated (myopia, hyperopia, astigmatism and presbyopia). It sells its products in approximately 60 countries, with direct distribution in the United States, Canada, Japan and Spain, and independent distribution in the remainder of the world.
