About the ASTRA Clinical Study

Evaluating the safety and potential effectiveness of an investigational therapy for corneal swelling.

Why This Study Is Being Conducted


The ASTRA study is evaluating AURN001, an investigational cell therapy made from human cultured donor endothelial cells mixed with a medication that helps the cells attach and survive. The study is designed to learn whether AURN001 may:
  • Replace diseased endothelial cells
  • Reduce corneal swelling
  • Restore normal fluid balance
  • Improve clarity and vision
Because AURN001 is investigational, results are still being studied and cannot be guaranteed.

How the Study Works

This is a randomized, double-masked study. Participants are placed into one of two groups by chance (like flipping a coin):

AURN001 Group

Receives the investigational therapy

Control Group

Receives the control solution
Neither participants nor the study doctors evaluating the eye will know which group each person is in. Only one eye is treated; the other eye is monitored.

What The Study Procedure Involves

All participants have the same study procedure. The procedure is done as an outpatient and includes:
  • Numbing eye drops
  • A small opening is made in the side of the front of the eye (1-2 millimeters)
  • Removal of the damaged endothelial cells
  • Injection of the study treatment (AURN001 or control solution)
  • A short face-down positioning period (about 3 hours)
The procedure is performed in an outpatient setting and typically takes about 30 minutes.

Rescue Treatment

Your study eye will be closely monitored throughout the study. If your eye gets worse or does not improve as expected, the study doctor will evaluate you and discuss next steps. You may be recommended to transition to standard of care treatment and exit the study early.
Standard of care treatment is not part of the study and is not covered by the study. It may include a corneal transplant, such as penetrating keratoplasty or endothelial keratoplasty. In the context of this study, this is referred to as rescue treatment. Any rescue treatment and subsequent evaluation after exiting the study will be provided as part of your standard medical care.

Study Duration and Visits

The ASTRA study lasts about 12 months and includes approximately 10–11 follow-up visits for eye health checks, vision tests, and monitoring.

About Aurion Biotech



Aurion Biotech develops innovative therapies for corneal diseases and aims to broaden global access to sight-restoring options.
AURN001 is investigational and not approved by the FDA.

Find a Study Doctor

AURN001 is investigational and not approved by the FDA. Participation is voluntary, and you may leave the study at any time. Declining to participate will not affect your standard medical care.