Eyegate Pharma (EYEG) Plans 510(k) De Novo Path for Ocular Bandage Gel

November 17, 2016 4:05 PM EST
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EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) 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 Company’s cross-linked, thiolated carboxymethyl hyaluronic acid (CMHA-S) platform. The Company plans to release top-line results by year-end, from its initial pilot study evaluating the ability of EyeGate OBG to accelerate ocular surface re-epithelialization following photorefractive keratectomy (“PRK”).

“We are extremely encouraged by our dialogue thus far with the FDA around EyeGate OBG, and are pleased to have a clear clinical and regulatory path forward for our first-in-kind eye drop that could accelerate recovery from post corneal surgery and injury,” said Stephen From, President and Chief Executive Officer of EyeGate. “We believe that the De Novo process, which is for medical devices without predicates, provides evidence of the novelty of our EyeGate OBG product. We look forward to announcing the top-line data from our PRK pilot study by the end of the year.”

The EyeGate OBG is a synthetic biocompatible CMHA-S hydrogel, capable of coating the ocular surface and designed to resist degradation under conditions present in the eye. This prolongs residence time of the bandage on the ocular surface, addressing the limitations of current non-cross-linked hyaluronic acid formulations. Additionally, cross-linking allows the product’s viscosity to be modified to meet optimum ocular needs. The EyeGate OBG is a sterile liquigel that is designed to be administered to the eye from a single-use vial four times per day for a maximum of 28 days.

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