EyeGate Pharmaceuticals announced that the first patient has been enrolled in its pilot study evaluating the ability of EyeGate’s Ocular Bandage Gel (OBG) to accelerate re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK) surgery.
“After receiving FDA approval of our IDE application, we are pleased to announce that our pilot study for patients who have undergone PRK surgery has enrolled its first patient at The Eye Institute in Salt Lake City, Utah,” Barbara Wirostko, MD, Chief Medical Officer of EyeGate, said in a company news release. “This study represents a significant step forward for our company as we move towards commercialization of a novel and proprietary crosslinked hyaluronic acid eyedrop and build on a wealth of existing data both in animals and more recently, in humans.”
The PRK pilot study will enroll up to 45 subjects undergoing a bilateral procedure in a reading center masked trial. The trial intends to compare EyeGate OBG to the current standard of care, bandage contact lens (BCL) plus artificial tears. The effectiveness endpoints will be the time to achieve complete wound healing and the percentage of subjects achieving complete wound healing on day 3 as evaluated by a masked reading center using digital photographs of fluorescein stained slit lamp photos.