EyeGate Pharmaceuticals, Inc. Announces Positive Top-Line Data from First-In-Human Pilot Trial of Ocular Bandage Gel in Corneal Epithelial Defects
January 30, 2017 at 08:30 am
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EyeGate Pharmaceuticals, Inc. announced topline results from the first-in-human pilot trial of its EyeGate Ocular Bandage Gel (“EyeGate OBG”) for the acceleration of re-epithelialization 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 second quarter 2017.
Kiora Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company. The Company is focused on developing and commercializing therapies for the treatment of orphan retinal diseases. Its pipeline consists of three product candidates, including KIO-301, KIO-104, KIO-101 and KIO-201. Its lead product, KIO-301, is a vision-restoring small molecule that is designed to restore vision in patients with inherited and age-related degenerative retinal diseases, including retinitis pigmentosa (RP). KIO-104 is a next generation, non-steroidal, immuno-modulatory, small-molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH), which is being develop for the treatment of Posterior Non-Infectious Uveitis, a rare T cell-mediated, intraocular inflammatory disease. KIO-101 focuses on treating the ocular manifestation of patients with autoimmune diseases, including rheumatoid arthritis, and as such is termed the Ocular Presentation of Rheumatoid Arthritis and Other Autoimmune Diseases (OPRA+).