EyeGate Pharmaceuticals announced that it has submitted an investigational device exemption (IDE) for the lead product in its cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform, EyeGate Ocular Bandage Gel (EyeGate OBG). The IDE, if accepted, will enable EyeGate to initiate a second pilot study of EyeGate OBG for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK), according to a company news release.
“The filing of this IDE represents an important step in the ongoing development of EyeGate OBG in corneal re-epithelialization. It comes as a direct result of our November 2016 pre-submission meeting with the FDA, at which the agency confirmed that regulatory clearance via a de novo 510(k) was the appropriate path forward for this novel medical device,” Stephen From, President and Chief Executive Officer of EyeGate, said in a company news release. “We are encouraged by our dialogue with the FDA to-date, which has clarified the clinical and regulatory path for our lead CMHA-S product candidate. We look forward to continued interaction during the IDE review process and are excited by the prospect of initiating this second pilot study, for which we expect top-line data in the second half of the year.”
The IDE submission is subject to review by the Center for Devices and Radiological Health (CDRH) of the FDA, and must be approved prior to initiating this study. The review process is expected to take a minimum of 30 days, with the total duration of the review to depend on a variety of factors including the extent of potential comments, questions and additional information requested by CDRH / FDA and the timeliness of EyeGate’s responses to any such comments, questions or requests for information.
The IDE for this study proposes a reading center masked trial enrolling up to 45 subjects undergoing a bilateral PRK procedure, and aims to compare EyeGate OBG to the current standard of care, bandage contact lens (BCL) plus artificial tears. Enrolled subjects will be randomized into three arms:
- EyeGate OBG administered four times daily (QID) for 14 days
- EyeGate OBG administered eight times daily for three days, followed by QID administration for 11 days
- BCL, with QID administration of artificial tears for 14 days
The study’s primary endpoint will be the percentage of subjects achieving complete wound healing (based on staining) on day 3.