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 (PRK) 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”, Stephen From, CEO of EyeGate, said in a company news release. 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.”