EyeGate Pharmaceuticals 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 (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).
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.
"We are pleased that our first IDE amendment addressed the majority of the 13 issues raised in the FDA’s initial response, and believe that the clarity of feedback provided in this letter gives us a clear path to approvability of the application,” Stephen From, President and Chief Executive Officer of EyeGate, said in a company news release. “We are now in the process of addressing the various points raised in the letter, mainly the validation of the sterile filtration of the CMHA material. According to the agency, one of the three filters used for validating the filter required for sterilizing the CMHA material did not pass the validation step by definition. To address this deficiency, our plan is to work with the manufacturer of the filter to complete the validation work using a different filter. We anticipate completing this work in the coming months, and are targeting the submission of a second amendment to the IDE application in July 2018. Assuming this next amendment is approved by the FDA, we would look to initiate the second EyeGate OBG pilot study in PRK patients later in the third quarter, with top-line data reported in Q4."
The IDE seeks approval for a proposed second pilot study of EyeGate OBG, enrolling up to 45 subjects undergoing a bilateral PRK procedure in a reading center masked trial. The goal of this study is 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 three days, followed by QID administration for 11 days, and BCL with QID administration of artificial tears for 14 days.
In March 2018, the company submitted an amended IDE comprising of the validation data on the manufacturing processes and bioburden tests related to production of EyeGate OBG, as well as data related to the analytical methods to identify and quantify impurities and degradation products.
The amended 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. Once submitted, the FDA will have 30 days to review the amendment and either request additional data or approve the initiation of the study.