Safety and Efficacy of Cultivated Allogeneic Corneal Endothelial Cells Attached to a Hydrogel Substrate (Endo-Tek™) as a Treatment for Corneal Endothelial Cell Dysfunction

Primary Objective: • To determine the safety and feasibility of using Endo Tek™ for the treatment of corneal endothelial disease/dysfunction. Secondary Objective: • To investigate the preliminary efficacy of Endo-Tek™ in the treatment of corneal endothelial disease by comparing visual acuity (VA), corneal thickness, and corneal endothelial cell (CEC) density in participants pre-operation (pre-OP) and post-operation (post-OP).

Inclusion Criteria: * Age ≥21 years * Participant or health care agent must understand and sign the informed consent form (ICF) * Participant must be medically suitable, willing to undergo the surgery and study procedures, and able to attend all follow-up visits * Phakic or pseudophakia with Fuchs dystrophy or pseudophakic bullous keratopathy Exclusion Criteria: * Corneal stromal scarring making standard EK surgery unsuitable at Screening Visit * Abnormal cornea or anterior segment of eye other than uncomplicated pseudophakia and corneal edema at Screening Visit