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EyeGate addresses some FDA action items for ocular bandage gel IDE amendment
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EyeGate Pharmaceuticals has addressed three of the four outstanding action items regarding an FDA investigational device exemption amendment filed for its ocular bandage gel, the company announced in a press release.
The FDA had requested clarification of previously submitted data, modifications to manufacturing process documentation and validation of a filter used in the sterilization process. EyeGate has provided clarification of questions on the data and documentation changes have been addressed, while the filter validation work continues, the release said.
“With this next step forward, we are now even closer to the initiation of the next stage of clinical studies. We anticipate addressing the fourth and final concern by the end of the second quarter of 2018, which would allow us to enter the clinic in the third quarter of 2018,” EyeGate President and CEO Stephen From said in the release.
The ocular bandage gel is under development to help accelerate re-epithelialization of large corneal epithelial defects in patients who have undergone PRK.