EyeGate announces additional data from PRK study
EyeGate announced that it has received additional topline data in its corneal wound repair pivotal study. As previously announced, the results of this pivotal study demonstrated statistically significant improvement in corneal re-epithelialization in patients treated with EyeGate's Ocular Bandage Gel, or OBG, eye drop versus the standard-of-care, a bandage contact lens, or BCL, post photorefractive keratectomy, or PRK, surgery. Additionally, OBG demonstrated a more rapid corneal wound closure over the standard-of-care as early as day two. The statistical significance measurement was based on the number of subjects in each arm that achieved complete corneal defect closure three days post refractive surgery. At day three, 80.2% of eyes receiving the OBG treatment regimen were completely healed, compared with 67% for BCL. This resulted in a p-value of 0.0203 in favor of OBG. In accordance with FDA standards, a p-value of 0.05 or less demonstrates superiority. PRK surgery is performed on both eyes at the same time. The patients were randomized and received identical treatment in both eyes, either OBG or BCL. Per the primary endpoint, one eye was assigned as the study eye. The additional data demonstrated a similar outcome on both eyes as the primary endpoint with a p-value of 0.0119 in favor of OBG. Furthermore, the data clearly demonstrated that patients treated with OBG experienced a faster healing process. At day 2, the average wound size for all eyes treated with OBG was only 3.61 mm2, compared to 6.66 mm2 for eyes treated with BCL, which is 46% smaller than the standard-of-care. The OBG eye drop was well tolerated with no safety concerns. There were two recurrent epithelial erosions captured in the standard-of-care group and zero in the OBG group. There were no serious adverse events related to OBG in the study. The company expects to receive the full data package in mid-December, but this will not include any additional efficacy or safety information.