US-based clinical-stage specialist pharmaceutical firm EyeGate Pharmaceuticals has reported positive topline results from the first-in-human pilot trial of its EyeGate Ocular Bandage Gel (EyeGate OBG) in corneal epithelial defects.
The EyeGate OBG is a clear viscous hydrogel eye drop with a 0.75% concentration of CMHA-S hydrogel developed to bolster the re-epithelialisation of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK).
The gel is claimed to be capable of coating the ocular surface with little to no optical blur and resists degradation under conditions of the eye.
The prospective, randomised, controlled study conducted in 39 subjects undergoing bilateral PRK surgery evaluated the safety and efficacy of EyeGate OBG as a monotherapy or in combination with a Bandage Contact Lens (BCL).
The primary endpoint of the study was complete wound closure by the third day.
EyeGate chief medical officer Barbara Wirostko said: “Corneal epithelial defects represent a large, underserved market with no approved eye drops available in the United States for accelerating corneal re-epithelisation.
"Such defects can lead to occular infections, inflammation, corneal neovascularisation, 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.”
The results indicated the safety and tolerability of EyeGate OBG and was found to meet the primary endpoint.
In the second quarter of this year, the firm intends to conduct a double-blind, controlled trial based on these results to assess EyeGate OBG monotherapy against BCL.