EyeGate Pharmaceuticals announced topline results from the first-in-human pilot trial of its EyeGate Ocular Bandage Gel, the acceleration of reepithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy ("PRK").
The EyeGate OBG is a clear viscous hydrogel eye drop with a 0.75% concentration of CMHA-S hydrogel, capable of coating the ocular surface with little to no optical blur and designed to resist degradation under conditions present in the eye. The prolonged residence time of the bandage on the ocular surface, it is thought, addresses the limitations of current non-cross-linked hyaluronic acid formulations.
The prospective, randomized, controlled study enrolled 39 subjects undergoing bilateral PRK surgery 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. The primary endpoint of the study was complete wound closure by Day 3.
The enrolled subjects were randomized into one of three study groups, with subjects receiving the same treatment in both eyes:
- Patients in arm 1 (n=12) received EyeGate Ocular Bandage Gel four times daily (QID) for 2 weeks after surgery
- Arm 2 (n=14) was comprised of EyeGate Ocular Bandage Gel QID for 2 weeks after surgery in combination with a BCL
- Arm 3 (n=13) was comprised of artificial tears administered 4 times daily and BCL.
The study demonstrated safety and tolerability of EyeGate OBG, with encouraging potential efficacy -- 75% of the subjects in Arm 1 (EyeGate OBG alone) achieved complete wound closure by Day 3, compared to 53.8% of patients that received the standard of care. Additionally, the average wound surface area on Day 1 (24 hours post-surgery) was 18.5 mm2 for patients in the EyeGate OBG alone arm compared to 39.5mm2 in the BCL arm, a 53.3% improvement.
Based on these positive results, EyeGate plans to continue development with a double-masked, controlled trial evaluating EyeGate OBG monotherapy against BCL in Q2 2017.
"The results of this pilot trial are extremely exciting, as Eyegate OBG not only showed safety and tolerability results, but also demonstrated encouraging signs of potential efficacy, with 9 of 12 subjects achieving complete closure by Day 3 and a significant reduction in average wound size just 24 hours after surgery," Dan Durrie, MD, Clinical Professor and Director of Refractive Surgery Services at the University of Kansas Medical Center and a Principal Investigator of study, said in a company news release. "These data suggest that the product has the potential to provide significant benefit in the treatment of various types of corneal epithelial defects."
Barbara Wirostko MD, Chief Medical Officer of EyeGate added, "Corneal epithelial defects represent a large, underserved market with no approved eye drops available in the United States for accelerating corneal re-epithelization. Such defects can lead to ocular infections, inflammation, corneal neovascularization, and vision loss if not treated promptly and effectively. The positive results from this pilot study of Eyegate OBG reinforces our belief in the product's potential as a viable option for the treatment of corneal epithelial defects. We are highly encouraged by the data and remain committed to further exploring EyeGate OBG in future clinical trials."