EyeGate completes randomization in OBG eye drop study
EyeGate Pharmaceuticals announced that it has completed randomization for its corneal wound repair pivotal study using the Ocular Bandage Gel eye drop. The study enrolled a total of 250 patients requiring corneal wound repair following photorefractive keratectomy surgery. The enrollment process included a formal screening to determine suitability for the procedure, followed by surgery and subsequent randomization into either the OBG or standard-of-care group. Of the enrolled and screened patients, 234 qualified for surgery and randomization into the study. "We are pleased with the efficiency of our team and sites for getting this study enrolled and keeping us on track for receiving topline data by year end 2019", said Stephen From, CEO of EyeGate. He continued, "This pivotal study potentially puts us in a position to submit the de novo application for commercialization in the first half of 2020." If EyeGate achieves successful completion of the PRK pivotal study and subsequent FDA approval, EyeGate believes OBG will be the only prescription hyaluronic acid eye drop in the U.S. and the only eye drop in the U.S. approved for the healing of corneal epithelial defects. Additionally, if the clinical trial for patients with PE is successful, EyeGate believes OBG will be the only eye drop in the U.S. approved for the treatment of PE.