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,
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