EyeGate Pharmaceuticals announced that it has submitted an amended Investigational Device Exemption (IDE) application to the FDA for a pilot study of the company's lead product, EyeGate Ocular Bandage Gel, a cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform. The amendment summarizes the company's responses to the FDA's questions and comments in response to the original IDE submission. The company is developing EyeGate OBG for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK).
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.
“The second pilot study is a critical step in the development of our Eyegate OBG for re-epithelialization of large corneal epithelial defects,” Stephen From, President and Chief Executive Officer of EyeGate, said in a company news release. “The clarity of feedback received from the FDA was very useful in the process of addressing the additional information that was needed for our original submission. Our team has worked hard to compile the large volume of manufacturing validation data, which will be crucial as we continue to move forward toward our planned 510(k) de novo filing in 2019. We are confident that we have addressed the Agency's concerns in our amended application and look forward to working cooperatively with the FDA during the review process. We are committed to bringing this platform product to patients with epithelial defects and anticipate initiating the study as soon as our application is approved.”
The proposed IDE submission for the pilot study will enroll up to 45 subjects undergoing a bilateral PRK procedure in a reading center masked trial. The trial intends to compare EyeGate OBG to the current standard of care, bandage contact lens (BCL) plus artificial tears. The primary endpoint will be the percentage of subjects achieving complete wound healing (based on staining) on day 3. Subjects enrolled in the study will be randomized into three arms: EyeGate OBG administered four times daily (QID) for 14 days, EyeGate OBG administered eight times daily for 3 days, followed by QID administration for 11 days and BCL, with QID administration of artificial tears for 14 days.
The IDE 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 FDA has 30 days to review the submission and provide a verdict on whether or not we can proceed into the clinical study or if additional data is required.