EyeGate Pharmaceuticals (NASDAQ:EYEG) has filed a protocol with the FDA for a follow-on pilot study using the Ocular Bandage Gel ("OBG") eye drop to treat punctate epitheliopathies ("PE") which can be associated with dry eye.
The FDA review process takes 30 days, where the agency will allow to initiate enrollment or will provide comments to be addressed.
The objective of this study is to evaluate several different exploratory performance endpoints in PE patients.
Following data from this study, expected by year end 2019, EyeGate plans to meet with the FDA to discuss the results and confirm the most ideal endpoint to use in the pivotal study.
The Company plans to have two clinical studies, expanding the uses for OBG.
Shares are up 14% premarket.
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