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Ocular bandage gel effective against corneal epithelial defects
EyeGate Pharmaceuticals Inc. announced the safety and tolerability of EyeGate Ocular Bandage Gel for the acceleration of re-epithelialization of large corneal epithelial defects in patients who have undergone photorefractive keratectomy.
EyeGate OBG is a clear viscous hydrogel eye drop with a 0.75% concentration of CMHA-S hydrogel, which coats the ocular surface with little to no optical blur and is designed to resist ocular degradation under conditions present in the eye, according to a press release.
The prospective, randomized, controlled pilot study enrolled 39 subjects undergoing bilateral PRK and aimed to assess the safety and performance of EyeGate OBG on its own or combined with a bandage contact lens (BCL) compared to the current standard of care, artificial tears and BCL.
Enrolled subjects were randomized into one of three study groups with subjects receiving the same treatment in both eyes: Arm 1 patients received EyeGate OBG four times daily for 2 weeks after surgery, Arm 2 patients received EyeGate OBG four times daily for 2 weeks after surgery in combination with a BCL, and patients in Arm 3 used artificial tears four times daily and a BCL.
A total of 75% of subjects in Arm 1 achieved complete wound closure by day 3 compared to 53.8% of patients that received the standard of care. The average wound surface area on day 1 was 18.5 mm2 for patients in the EyeGate OBG alone arm compared to 39.5 mm2 in the BCL arm, a 53.3% improvement.
EyeGate plans to continue development with a double-masked, controlled trial evaluating EyeGate OBG monotherapy against BCL in the second quarter of 2017.