EyeGate Receives FDA Feedback on Investigational Device Exemption Amendment for Second Pilot Study of Ocular Bandage Gel

EyeGate Pharmaceuticals (NASDAQ:EYEG) a clinical-stage, specialty pharmaceutical company with two proprietary platform technologies for treating diseases and disorders of the eye, today announced that it has received a letter from the U.S. Food and Drug Administration (FDA) responding to the Company’s amended investigational device exemption (IDE) application for a second pilot study of the Company’s lead product, EyeGate Ocular Bandage Gel (EyeGate OBG), a cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform being developed for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK).

As quoted in the press release:

In its letter, the FDA identified four deficiencies in the Company’s submission, requesting additional information on the manufacturing processes associated with the EyeGate OBG product. The primary comment relates to the validation of the filter specifically used for sterilization of the CMHA material, while the remaining comments include a request for clarification to the previously submitted data and modifications to the manufacturing process documents.

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