April 9, 2018 / 1:14 PM / 5 months ago

BRIEF-Eyegate Receives FDA Feedback On Investigational Device Exemption Amendment For Second Pilot Study Of Ocular Bandage Gel

April 9 (Reuters) - EyeGate Pharmaceuticals Inc:

* EYEGATE RECEIVES FDA FEEDBACK ON INVESTIGATIONAL DEVICE EXEMPTION AMENDMENT FOR SECOND PILOT STUDY OF OCULAR BANDAGE GEL

* IN ITS LETTER, FDA IDENTIFIED FOUR DEFICIENCIES IN COMPANY'S SUBMISSION

* FDA REQUESTED ADDITIONAL INFORMATION ON MANUFACTURING PROCESSES ASSOCIATED WITH EYEGATE OBG PRODUCT

* CO TARGETING SUBMISSION OF A SECOND AMENDMENT TO IDE APPLICATION IN JULY 2018

* IN U.S. FDA'S LETTER, PRIMARY COMMENT RELATES TO VALIDATION OF FILTER SPECIFICALLY USED FOR STERILIZATION OF CMHA MATERIAL Source text for Eikon: Further company coverage: (Reuters.Briefs@thomsonreuters.com)

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