Aurion Biotech has just released the results from their clinical trial called IOTA. This trial was conducted by researchers in Japan and demonstrated that corneal endothelial cell therapy was able to improve corneal thickness as well as visual acuity.

Corneal endothelial cell therapy was first created by Shigeru Kinoshita. He works at the University of Medicine in Japan.

The initial results were published in the New England Journal of Medicine. 

Corneal Edema

Corneal edema occurs when the corneal endothelial cells die or degrade. Unfortunately, these cells are not able to regenerate. This means that if they die, loss of vision is inevitable.

Current solutions to this problem include transplants using DMEK and DSAEK. Unfortunately, these are complex procedures, few doctors hold the expertise, and there is a very limited supply of donor corners.

Corneal Endothelial Cell Therapy 

This new procedure is promising for many reasons. First, corneal endothelial cells are not hard to find. They are very abundant. Just one donor could treat as many as 100 patients. Additionally, the procedure itself is rather easy and not very invasive. Patients are able to recover in just a few hours.

The procedure takes place in three steps. First, the surgeon removes the diseased part of the endothelium. Then, cultured cells are injected into the anterior chamber. Next, the patient is monitored while they recover for around 3 hours.

Kinoshita has now performed this procedure in over 60 patients with very positive outcomes.

IOTA Trial 

This investigation took place in El Salvador. It was the first study of its kind to occur outside of Japan. It demonstrated that corneal endothelial cell therapy was safe, effective, and well-tolerated for patients.

The trial included two parts. In the first part, 16 patients were treated with cells from one donor. The treatment was injected into the eyes with the hope that it would restore vision and reduce corneal edema. This was found to be the case as patients experienced improved corneal thickness and visual acuity.

In the second part of the trial, there were 34 patients treated by the same donor.

All patients will be monitored for a full year to better understand long-term efficacy of the treatment as well as its safety. 

Corneal endothelial patients often face difficulty receiving treatment due to a lack of supply of donor corneas, complex standard of care procedures, and lack of physician expertise. This new treatment is both accessible to surgeons and minimally invasive for the patients.

Aurion Biotech is hopeful that they can receive approval for this therapy across the world, supporting patients globally.

You can read more about this treatment here.