Eyegate Pharma (EYEG) Plans 510(k) De Novo Path for Ocular Bandage Gel
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FDA Confirms a 510(k) De Novo Path for EyeGate’s Device, the Ocular Bandage Gel, Following Pre-Submission Meeting
November 17, 2016 4:01 PM ESTWALTHAM, Mass., Nov. 17, 2016 (GLOBE NEWSWIRE) -- EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) (EyeGate or the Company), a clinical-stage specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and disorders of the eye, today announced that, following a pre-submission meeting with the U.S. Food & Drug Administration (FDA), it plans to pursue U.S. regulatory clearance of its EyeGate Ocular Bandage Gel (EyeGate OBG), via the De Novo 510(k) pathway. EyeGate OBG is the lead product candidate from the Companys cross-linked, thiolated carboxymethyl hyaluronic acid (CMHA-S) platform. The Company plans to release... More
