FDA identifies deficiencies in amended IDE application for EyeGate Ocular Bandage Gel study

The FDA identified four deficiencies in an amended investigational device exemption application for a second pilot study of product candidate EyeGate Ocular Bandage Gel and is requesting additional information on the manufacturing process, according to a press release from EyeGate Pharmaceuticals.

The original submission for the cross-linked thiolated carboxymethyl hyaluronic acid (CMHA) platform, which is designed for the acceleration of re-epithelialization of large corneal epithelial defects in those who have undergone PRK, had 13 issues raised in the FDA’s response.

“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 CEO of EyeGate, said in the release.

The primary comment from the FDA in the most recent letter was related to the validation of the filter used for sterilization of the CMHA material, the release said.

“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,” From said.

The other comments included “a request for clarification to the previously submitted data and modifications to the manufacturing process documents,” the release said.

A second amendment to the IDE application is planned for July.