Consistency Of Outcomes With Injectable Human Corneal Endothelial Cell Therapy Across Multiple Clinical Trials

To compare safety and efficacy outcomes of injectable human corneal endothelial cells from three clinical trials across different geographies in subjects with corneal edema secondary to endothelial dysfunction.

Prospective clinical trials conducted in Japan and El Salvador have evaluated a single intracameral injection of human corneal endothelial cells in combination with ROCK inhibitor in subjects with corneal edema.

Comparative retrospective analysis of outcomes was conducted between 65 subjects treated in the first-in-human investigator-initiated trial (Japan), 16 subjects treated in the exploratory IOTA trial (El Salvador), and 22 subjects treated in the Escalón trial (El Salvador). These clinical trials included multiple surgeons and subjects were followed for 12 months. 

Similar safety and efficacy outcomes were observed in the Japan, IOTA and Escalón clinical trials. At 12 months, mean improvement in BCVA was 0.79 LogMAR, 1.00 LogMAR, and 0.66 LogMAR; mean CCT improved by 25%, 24%, and 19%, and percentage 3-line improvement in BCVA was 89%, 100% and 89% among each trial respectively. There were no treatment related systemic or ocular SAEs. 

A single intracameral injection of human corneal endothelial cells in combination with ROCK inhibitor was generally well tolerated and demonstrated comparable and repeatable efficacy outcomes out to 12 months as measured by BCVA and CCT in subjects with corneal endothelial dysfunction across different geographies involving multiple surgeons.