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FDA approves IDEs for EyeGate’s ocular bandage gel

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The FDA has approved two investigational device exemption applications for pilot studies of EyeGate’s ocular bandage gel, the company announced in a press release.

The first pilot study will evaluate the ocular bandage gel in 45 patients who have undergone photorefractive keratectomy. It will compare wound healing in patients who use the product to those who receive the standard of care, which is a bandage contact lens and artificial tears.

The second study will include 30 patients with punctate epitheliopathies and will evaluate the change in corneal staining after 6 weeks with the ocular bandage gel vs. a comparator.

“Receiving FDA approval for both pilot studies is a significant milestone in the development of our EyeGate OBG platform,” company CEO Stephen From said. “EyeGate is very pleased to have received these approvals and we look forward to getting these studies underway, as we expect to initiate the clinical trials in the third quarter.”