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EyeGate amends IDE application for ocular bandage gel

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EyeGate Pharmaceuticals has submitted an amended investigational device exemption application to the FDA for a pilot study of EyeGate Ocular Bandage Gel.

The application responds to the FDA’s questions and comments regarding the original IDE submission, according to a company press release: “The amendment includes validation data on the manufacturing processes and bioburden tests related to production of EyeGate OBG. It comprises data related to the analytical methods to identify and quantify impurities and degradation products.”

EyeGate OBG, the company’s lead product, is a cross-linked thiolated carboxymethyl hyaluronic acid platform intended to accelerate reepithelialization of large corneal epithelial defects in patients who have undergone PRK, according to the release.

The proposed pilot study would enroll up to 45 subjects undergoing a bilateral PRK procedure and would compare OBG with bandage contact lenses plus artificial tears, the current standard of care. The primary endpoint of the trial would be the percentage of patients achieving complete wound healing.