Development of a 3D corneal epithelial model for early biocompatibility screening of topical ophthalmic formulations

Abstract

In the development of topical ophthalmic formulations, an important aspect of characterization is the study of the effect of the formulation on the corneal epithelium. The most extensively characterized human cell line used in corneal biocompatibility studies is the immortalized human corneal epithelial cell line (HCE-T) (Juretić et al., 2017). Most in vitro biocompatibility studies are currently performed with cells cultured in a twodimensional (2D) environment (Fitzgerald et al., 2015), which does not accurately reflect the structure of the corneal epithelium in vivo. The use of such inappropriate experimental tools may lead to misleading conclusions about the biocompatibility of investigated formulations. The objective of this research was to develop a threedimensional (3D) HCE-T cell model grown on 96-well insert plates. Such model simulates 3D structure of corneal epithelium and would enable an improved in vitro biocompatibility screening in terms of throughput and robustness in the development of topical ophthalmic formulations.