EyeGate Pharmaceuticals announced topline data from its study evaluating the potential of EyeGate’s Ocular Bandage Gel (OBG) to help clinicians better manage corneal epithelial defects in patients following photorefractive keratectomy (PRK) surgery, compared to current standard of care.
“This is the first time I have seen a product heal an epithelial defect without a bandage contact lens,” Daniel S. Durrie, MD, Founder, Durrie Vision in Overland Park, Kansas said in a company news release. “Working with PRK patients creates an ideal epithelial defect challenge model to demonstrate the potential to heal all types of ocular surface wounds.”
The PRK study enrolled 45 subjects undergoing a bilateral PRK procedure. The trial was designed to assess safety and efficacy by comparing two dosing regimens of EyeGate’s OBG to the current standard of care, a bandage contact lens plus artificial tears. The efficacy assessments included the percentage of subjects achieving complete wound healing on day 3 and day 4 and wound size on day 3. These assessments were evaluated by an independent masked reading center, using digital slit-lamp photographs of fluorescein staining in all treated eyes, and a protocol-driven method in order to quantify the outcomes.
Both of the OBG dosing regimens outperformed the standard of care in the number of eyes healed at day 3 and day 4 post-surgery. At day 3, 73% and 87% of eyes receiving the two OBG treatment regimens were completely healed compared with 67% for standard-of-care. At day 4 post-surgery, 100% in both OBG treatment groups were completely healed, vs. 87% in the standard-of-care comparator group. Additionally, the maximum wound size was 67% and 49% smaller at day 2 post-surgery for the two OBG groups compared to the standard-of-care. Importantly, there were no safety concerns observed in any group.
“We are very pleased with the data from this second PRK study, which demonstrated the ability to replicate the data from our first study,” Stephen From, CEO of EyeGate, said in a company news release. “This data showed a similar magnitude and rate of response reinforcing our belief that OBG has the potential to manage the healing of epithelial corneal wounds. Consequently, we believe that all of our data is sufficient and robust enough to create a path toward regulatory filings for approval and commercialization.”