EyeGate Addresses Final FDA Action Item with Submission of IDE Amendment for Ocular Bandage Gel

EyeGate Pharmaceuticals (NASDAQ:EYEG) has announced it has addressed the final action item in the US Food and Drug Administration’s (FDA) approval of its investigational device exemption for a second pilot study if its ocular bandage gel.

As quoted in the press release:

EyeGate’s product is 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).

In the original IDE amendment response letter, the FDA identified four insufficiencies in the Company’s submission and requested additional information on the manufacturing processes associated with the EyeGate OBG product. This amendment addresses the final FDA concern regarding the validation of a filter used in the sterilization process. The previous FDA action items were addressed in an amendment, filed on May 22, 2018, and were cleared by the FDA on June 18, 2018.

Stephen From, President and Chief Executive Officer of EyeGate, said, “We are pleased to have completed our response to the FDA’s final comment.” Mr. From continued, “With this final comment addressed, and the previous action items cleared, we believe we have a pathway to approval to initiate of the next stage of clinical studies. We anticipate entering the clinic in the third quarter of 2018.”

Click here to read the full press release.