Benzinga | Jul 14, 2020 06:56AM EDT

EyeGate Pharma To Proceed With PE Pivotal Study

WALTHAM, MA / ACCESSWIRE / July 14, 2020 / EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) ("EyeGate" or "the Company"), a clinical-stage company focused on developing products for treating disorders of the eye, announced today that based on feedback from a meeting with the U.S. Food and Drug Administration ("FDA"), EyeGate can move forward with the filing of an IDE for a punctate epitheliopathies ("PE") pivotal study.

This pivotal study follows the successful completion of EyeGate's pilot study in early 2020. The pivotal study will evaluate the effectiveness and safety of EyeGate's Ocular Bandage Gel eye drop in reducing PEs in a dry eye patient population to be further defined in the IDE. Prior to filing the IDE application for the pivotal study, the Company must perform additional testing for the new packaging, a multi-dose preservative-free bottle, as previously discussed with the FDA. The Company anticipates completing this testing by the end of 2020.