Precise-Bio Vision Endothelial Keratoplasty For Endothelial Decompensation

Precise-Bio Vision Endothelial Keratoplasty (PVEK) is a biofabricated corneal implant comprised of a collagen-based scaffold and high density printed donor-expanded human endothelial cells. The purpose of this study was to report the outcomes of PVEK in rabbit model.

This report describes the outcomes of the PVEK implant in a rabbit model.

Rabbits underwent an 8.25 mm descemetorhexis after which a PVEK implant was placed using an endotamponade with C3F8. Main outcome measures were cornea cloudiness (grade 0-4) and optical coherence tomography derived central corneal thickness at one month. Secondary outcomes were endothelial cell counts.

PVEK implants were found easy to manipulate and transplant by 3 different cornea experts. No device related serious adverse events were noted. Rebubbling was performed when detachments were observed (10/20). The implant remained attached at final follow up in 17/20 (85%) of the cases. At one month the cornea cloudiness was 0.23±0.83 (Scale 0-4 observed by Biomicroscopy). The mean central corneal thickness was 498±243 (Average Rabbit corneal thickness is 340-380µm). Endothelial cell count at one month follow up for PVEK implants was 2303±222.

Precise-Bio demonstrates the ability to produce functional corneal endothelial PVEK implants for replacement of damaged corneal endothelial cells for the treatment of human keratoplasty under a strict quality-controlled process tested for viability, density, identity, potency and sterility. PVEK led to a clear and compact cornea with high postoperative cell counts in a rabbit model. PVEK is a promising technology for corneal endothelial dysfunction. We expect first in human to be perfomed in Q4 of 2024.