The FDA identified four deficiencies in an amended investigational device exemption application for a second pilot study of product candidate EyeGate Ocular Bandage Gel and is requesting additional information on the manufacturing process, according to a press release from EyeGate Pharmaceuticals.
The original submission for the cross-linked thiolated carboxymethyl hyaluronic acid (CMHA) platform, which is designed for the acceleration of re-epithelialization of large corneal epithelial defects in those who have undergone PRK, had 13 issues raised in the FDA’s response.
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