PORTLAND, Ore. — Paragon BioTeck, Inc., a privately held biopharmaceutical and medical device company specializing in the development of ophthalmic pharmaceuticals, devices and therapies, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (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 Comfortear® 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.
About Comfortear® Lacrisolve™ Absorbable Punctum Plug
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. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are available in two diameters: 0.4mm and 0.5mm. The implants are supplied sterile with two implants per package. Absorption time for the Comfortear® Lacrisolve™ Absorbable Punctum Plugs is approximately 6 months (=<6). For full prescribing information, visit paragonbioteck.com.
Product Availability
The Comfortear® Lacrisolve™ Absorbable Punctum Plugs will ship July 2014. To preorder or find out more about Paragon’s products, call 888-424-1192. Product orders or inquiries can also be sent to orders@paragonbioteck.com.
About Paragon BioTeck, Inc.
Paragon BioTeck, Inc. is a privately held ophthalmic-focused biopharmaceutical and medical device company pursuing the development and commercialization of products addressing unmet medical needs in the fight to protect and preserve eyesight.
