ESCRS - FP22.09 - Initial Experience With First-In-Human Bioengineered Corneal Endothelial Implantation (Pvek)

Initial Experience With First-In-Human Bioengineered Corneal Endothelial Implantation (Pvek)

Published 2026 - 44th Congress of the ESCRS

Reference: FP22.09 | Type: Free paper | DOI: 10.82333/ah9y-fh98

Authors: Prof. Michael Mimouni* 1 , A/Prof. Eitan Livny 2 , Mr Yishay Hayardeni 3 , Mr Amos Eitan 3 , Mrs Lior Rosenberg Belmaker 3 , A/Prof. David Zadok 4

1Ophthalmology,Rambam Health Care Campus,Haifa,Israel, 2Ophthalmology,Rabin Medical Center,Petah Tikva,Israel, 3Precise Bio LTD,Modiin Maccabim Reut,Israel, 4Ophthalmology,Shaare Zedek Medical Center,Jerusalem,Israel

Purpose

To describe our initial experience with first-in-human transplantation of the bioengineered Precise Vision Endothelial Keratoplasty (PVEK) implant for the treatment of corneal edema due to endothelial dysfunction.

Setting

Tertiary Medical Center

Methods

In this prospective study, consecutive patients with corneal edema secondary to endothelial cell loss underwent PVEK implantation using a Descemet Membrane Endothelial Keratoplasty (DMEK)-like surgical technique. The PVEK implant consists of a collagen-based scaffold seeded with allogeneic human corneal endothelial cells. Using this method 300-500 PVEK grafts may be produced from a single deceased donor. Postoperative assessment included slit-lamp biomicroscopy, corneal thickness measurements, visual acuity, intraocular pressure, and monitoring for adverse events.

Results

Three eyes underwent PVEK implantation with follow-up ranging from 3 weeks to 3 months. In the first patient (3-month follow-up), central graft attachment was maintained following rebubbling, with normalization of central corneal thickness (≈475–485 µm) and improvement in best-corrected visual acuity to 0.5–0.6 (decimal). Two additional patients were recently transplanted, are currently in close follow up. For all three patients no serious adverse events, uncontrolled intraocular pressure, or primary graft failures were observed to date.

Conclusions

First-in-human PVEK implantation appears surgically feasible and capable of achieving sustained central graft attachment and corneal deturgescence at 3 months. To date, no serious adverse events or primary graft failures were observed. Further follow-up and additional cases are needed to evaluate long-term endothelial function, safety, and reproducibility