EyeGate Pharmaceuticals announced topline data from its study evaluating the potential of EyeGate’s Ocular Bandage Gel (OBG) to help clinicians better manage patients with punctate epitheliopathies (PE) due to pathologies such as dry eye.
“A product that achieves symptomology results as seen in this study is exactly what ophthalmologists want access to when treating patients,” Randall J Olson, MD, CEO and Chair of the Department of Ophthalmology and Visual Sciences of the John A. Moran Eye Center, University of Utah, SLC, said in a company news release. “With the wound healing results demonstrated in the two PRK studies along with these results, there is potentially a huge opportunity for using OBG in the management of various ocular surface conditions.”
This controlled, masked study enrolled 30 subjects with punctate epitheliopathies (PE) due to pathologies such as dry eye. The trial was designed to assess safety and efficacy by comparing EyeGate’s OBG to the comparator group, a commercially available rewetting eye drop. The assessments included corneal fluorescein staining and symptomology at day 7, day 14 and day 28. Randomization occurred after a 2-week run in period where all subjects were taking the rewetting eye drops only. Patients with a corneal staining score on NEI scale of ≥4 entered the treatment phase and either continued to receive rewetting eye drops or were switched to OBG eye drops.
OBG eye drops achieved a statistically significant improvement (P < 0.05) in symptoms as quickly as day 7 and also at day 28. Additionally, at day 28 OBG realized a 30% decrease from baseline vs. only 4% for the comparator group. Symptomology was assessed using a patient reported outcome questionnaire based on comfort in both eyes. Staining measurements of the central cornea, a region dense in nerve endings, showed a reduction of up to 40% for OBG vs. up to 23% for the rewetting eye drop arm when combining the results from both eyes, which we believe better correlates clinically with the symptomology results. Staining measurements of the total cornea did not show a significant difference in reduction between the two arms with 26% for OBG vs. 23% for the rewetting eye drop at day 7. Importantly, there were no safety concerns observed in any group.
Stephen From, CEO of EyeGate, said, “We are extremely pleased with the remarkable data achieved in symptomology from our first study in PE patients. OBG showed improvement over a commercially available rewetting eye drop on each of the subcategories of the symptomology questionnaire. We are not aware of any product that has demonstrated this magnitude and speed of improvement in this patient population. Consequently, we believe that all of our data is sufficient and robust enough to create a path toward regulatory filings for approval and commercialization.”