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EyeGate files Ocular Bandage Gel IDE supplement for punctate epitheliopathy

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EyeGate Pharmaceuticals has filed a supplement to its investigational device exemption for punctate epitheliopathy using its Ocular Bandage Gel, according to a press release.

“The filing of this IDE supplement represents the next step for our OBG platform and shows EyeGate’s continued progress,” Stephen From, EyeGate president and CEO, said in the release. “We are hopeful that we will receive a positive response to this IDE supplement and will be able to move into the clinic in the second half of 2018.”

The IDE for the Ocular Bandage Gel was initially filed for use in accelerating re-epithelialization of large corneal epithelial defects in patients who underwent PRK. It is currently under review for four items cited by the FDA; the company has addressed three items, and the fourth is expected to be addressed by the end of the second quarter.

Once the IDE is approved and the four outstanding items are positively resolved, clinical trials for punctate epitheliopathy may begin.