Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction

APANECA: A Prospective, Parallel-arm, Multi-Surgeon Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (2024-E002-C)

The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to endothelial dysfunction.

Inclusion Criteria:

• Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
• BCVA no worse than 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent).

Exclusion Criteria:

• Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye
• Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments