Recruiting
Phase 3

AURN001

Sponsor:

Aurion Biotech

Code:

NCT07368959

Conditions

Corneal Edema

Corneal Endothelial Dysfunction

Fuchs Endothelial Corneal Dysfunction

Pseudophakic Bullous Keratopathy (PBK)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Combination Product: AURN001 + Y-27632

Placebo

Study Details

Brief summary:

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.

Conditions

Corneal Edema

Corneal Endothelial Dysfunction

Fuchs Endothelial Corneal Dysfunction

Pseudophakic Bullous Keratopathy (PBK)

Study ID

NCT07368959

Start date

Feb 19, 2026

Status verified date

May, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AURN001

Participants will receive single dose of AURN001

placebo comparator: Placebo

Participants will receive single dose of placebo control.

Interventions

Combination Product: AURN001 + Y-27632

AURN001 will be injected to the anterior chamber of the eye.

Placebo

Placebo control will be injected to the anterior chamber of the eye.

Primary outcome measure

  • Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6 [ Time Frame: At Month 6 ]

Central Contacts and Locations

Central contacts

Aurion Study Team

1-857-639-4163ASTRA@aurionbiotech.com

Locations

Investigational Site 2

Recruiting

Mesa, Arizona, United States, 85206

Investigational Site 6

Recruiting

Little Rock, Arkansas, United States, 72205

Investigational Site 9

Recruiting

Fort Collins, Colorado, United States, 80528

Investigational Site 7

Recruiting

Atlanta, Georgia, United States, 30339

Investigational Site 4

Recruiting

Kansas City, Missouri, United States, 64154

Investigational Site 11

Recruiting

Leland, North Carolina, United States, 28451

Investigational Site 5

Recruiting

Winston-Salem, North Carolina, United States, 27157

Investigational Site 3

Recruiting

Cynwyd, Pennsylvania, United States, 19004

Investigational Site 10

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Investigational Site 12

Recruiting

Ladson, South Carolina, United States, 29456

Investigational Site 8

Recruiting

San Antonio, Texas, United States, 78209

Investigational Site 1

Recruiting

Spring, Texas, United States, 77388

More Information

Sponsor

Aurion Biotech

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Best Corrected Visual Acuity
  • Central corneal thickness
  • Human Corneal Endothelial Cells
  • Neltependocel
  • Postsurgical endothelial dysfunction
  • Keratoplasty
  • Pseudophakic Corneal Edema (PCE)
  • Corneal Endothelial Cells
  • Endothelial Cells
  • AURN001
  • Y-27632
  • Endothelial Keratoplasty
  • Corneal Endothelial Cell Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aurion Biotech on 2026-05-22.