Paragon BioTeck, Inc., a privately held biopharmaceutical and medical device company specialising in the development of ophthalmic pharmaceuticals, devices and therapies, announced it has received 510(k) clearance from the US Food and Drug Administration (US FDA) to market its Comfortear Lacrisolve Absorbable Punctum Plug.
“Receiving FDA 510(k) clearance for this device is an important milestone for Paragon. Dry eye affects over 4.8 million people in the US and, keeping with Paragon’s ultimate goal to protect and preserve eyesight, the Comfortea Lacrisolve Absorbable Punctum Plug is a great addition to our portfolio of FDA regulated ophthalmic products,” says Lauren M-C Bluett, Director of Quality Assurance.
Comprised of the synthetic absorbable polymer, polydioxanone, the Comfortear Lacrisolve Absorbable Punctum Plugs are medium-term implants designed to be inserted into the canaliculus in order to block tear drainage through the lacrimal drainage system.