Guttae modifying effect following intracameral injection of magnetically delivered human corneal endothelial cells in Fuchs endothelial corneal dystrophy

Purpose To evaluate the quantitative changes in the number and spatial distribution of corneal guttae in subjects with Fuchs endothelial corneal dystrophy (FECD) following a single intracameral injection of allogeneic magnetic human corneal endothelial cells (EO2002). Methods This prospective analysis included participants from a Phase 1 U.S. multicenter study who received an intracameral injection of EO2002 without concurrent endothelial polishing (endobrushing) or Descemet membrane stripping. High-resolution retroillumination images of the central cornea were captured at pre-injection (baseline), 3 months, and 6 months post-treatment. Corneal guttae were meticulously quantified by two independent, masked graders using a standardized protocol involving a 7-zone concentric circular grid overlaid on the images. Inter-grader reliability was assessed. Results Four participants who met the inclusion criteria were analyzed. A significant reduction in central corneal guttae was observed. The mean percentage decrease in guttae count compared to pre-injection in the central analytical zones was 53% ± 28% (standard deviation) at 3 months, progressing to 70% ± 16% at 6 months. The reduction was most pronounced in the central and paracentral zones, corresponding to the primary targeted delivery area of the magnetically guided cells, with a diminishing effect towards the periphery. Conclusions This study provides the first quantitative evidence of visible guttae reduction per retroillumination photography in FECD following endothelial cell therapy, without endo-polishing, Descemet membrane stripping or surgical manipulation. Our findings suggest that magnetically guided allogeneic CEC therapy may alter the Descemet membrane-endothelial complex in FECD.