Early Clinical Outcomes of Cultured Human Corneal Endothelial Cell Injection (Vyznova) for Bullous Keratopathy: Initial Clinical Experience.

Abstract

Purpose: To report early clinical outcomes of cultured human corneal endothelial cell (cHCEC) injection therapy (Vyznova) for bullous keratopathy (BK). To our knowledge, this is the first study reporting use of an initial commercial lot of Vyznova implemented at 3 independent institutions specializing in corneal transplantation in Japan.

Methods: This retrospective case series included 4 eyes of 4 patients (mean age, 76.8 years, 1 man, 3 women) with BK owing to Fuchs endothelial corneal dystrophy (n = 2), pseudophakic bullous keratopathy (n = 1), or primary angle-closure disease (n = 1), treated between August 2024 and October 2024. All patients received an intracameral injection of 1.0 × 106 cHCECs (Vyznova). Best-corrected visual acuity (BCVA), central corneal thickness (CCT), and endothelial cell density (ECD) were assessed preoperatively and 6 months postoperatively. Complications were also recorded.

Results: In the 3 uncomplicated cases, corneal clarity was restored by 6 months, and BCVA improved from a mean of 0.20 to 0.55. Mean CCT reduced from 729 μm to 586 μm, and ECD reached 2483 cells/mm2 mean (unmeasurable preoperatively). Corneal clarity was also achieved in 1 case with intraoperative and postoperative Descemet membrane detachment. However, BCVA remained unchanged at 0.5, CCT increased from 646 μm to 689 μm, and ECD was 660 cells/mm2.

Conclusions: Vyznova therapy seems to be effective in restoring corneal clarity in patients with BK. This real-world experience underscores the feasibility of implementing cHCEC injections in institutions beyond the developer sites. Careful intraoperative management is necessary to avoid complications, such as detachment of Descemet membrane.