AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction

ASTRA: A Phase 3 Multi-center, Randomized, Double-Masked, Prospective Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-3)

The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.

Key Ocular Inclusion Criteria:

(All ocular criteria apply to the study eye unless noted otherwise)

• Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
• BCVA between 65 ETDRS letters (approximate 20/50 Snellen equivalent) and 5 ETDRS letters (approximate 20/800 Snellen equivalent)
• Be pseudophakic with PCIOL

Key Ocular Exclusion Criteria:

(All ocular criteria apply to the study eye unless noted otherwise)

• Have progressive corneal dystrophies or degenerations
• Have visually significant corneal or other ocular pathologies

Other inclusion/exclusion criteria may apply.