Pre-Clinical Assessment Of A Novel Intra-Conal Glaucoma Drainage Device – The Eshunt – 6 Months Follow Up And Pathology Data From Rabbits

To assess the safety of the eShunt, a small lumen drainage device designed for the treatment of severe and refractory glaucoma patients.

Animal CRO facility - Lahav Labs

The development process of the eShunt surgical implant and implantation procedure included validating the design and the clinical assumptions on animal models. Throughout the process the eShunt was implanted in NZW rabbits and pigs on multiple occasions until culmination of the R&D process and the arrival at design freeze. Following the design freeze, a GLP NZW rabbit trial lasting 6 months was conducted to assess safety prior to First in Human implantations. The eShunt was implanted in 14 NZW rabbits, 8 were followed up for 6 months and 6 for 3 months. Clinical assessments were performed throughout and upon termination, histological assessment and for local tissue response and flow tests on the explanted devices were performed.

The eShunt was found safe at the conclusion of this trial. Clinical assessments revealed no hypotony, or infectious complications although some transient exposures of the covering patch were recognized early during the follow up. Histological assessment showed tissue integration with the covering patch with no residual inflammatory response at 6 months. The explanted eShunts were subjected to pressure gradient assessment at the end of the trial after being separated from the surrounding tissue. This assessment yielded no significant change from the gradient measured prior to implantation.

The eShunt was found safe in an animal model. This animal study will be shortly followed by an Early Feasibility Study (EFS).