Translation Landscape of Corneal Endothelial Tissue Engineering: A Scoping Review

Background Corneal endothelial dysfunction is a leading cause of global blindness. The main treatment is full keratoplasty, for which access is limited due to the worldwide shortage of tissue donors. Corneal tissue engineering has shown significant progress, yet there are still challenges in the path of its clinical adoption. Objective To map the translational landscape of corneal endothelial tissue engineering by integrating evidence on scientific development, intellectual property activity, commercialization signals, health-economic considerations, and clinician perspectives. Methods A scoping review was conducted using a translational framework that combined bibliometric mapping, patent activity, identification of companies and technology development status, an exploratory scenario-based cost-utility model comparing a biosynthetic corneal endothelial construct (BCET) with donor Descemet membrane endothelial keratoplasty (DMEK), and a survey of Latin American corneal surgeons assessing perceived barriers and adoption readiness. Results A total of 614 publications met the inclusion criteria, with a sustained scientific output over the last decade. Research activity was dominated by corneal endothelial tissue engineering and cell-based replacement strategies. Patent analysis identified 26 registers, while 10 companies appeared among the papers’ affiliations. The exploratory cost-utility scenario suggested that a BCET could represent a net gain of 1.04 QALYs per patient over the 10-year time horizon. Survey responses from 30 Latin American corneal surgeons revealed high interest in adopting engineered endothelial therapies. However, manufacturing capacity, regulatory approval, reimbursement, and long-term clinical evidence were consistently identified as the principal barriers to implementation. Conclusions Corneal endothelium engineering has achieved significant scientific maturity but has seen little translational progress. Further analysis to deepen understanding of regulatory bottlenecks, along with academic approaches that support the clinical adoption of new technologies through a translational-by-design approach, could shed light on better ways for early adoption and efficient clinical translation.