Improving Outcomes in Corneal Endothelial Disease With Cell Therapy

This content originally appeared on our sister site, Ophthalmology Times.

Ophthalmology Times spoke with Greg Kunst, chief executive officer, Aurion Biotech, at the 2021 American Academy of Ophthalmology annual meeting to learn more about the company's plans to initiate clinical trials of cell therapy for the potential treatment of corneal endothelial disease.

Aurion's lead cell therapy candidate is Vyznova, which has demonstrated safety, efficacy and tolerability in corneal endothelial disease in clinical trials in Japan. The company is preparing a new drug application for the cell therapy in Japan and will soon initiate clinical trials in the US.

Transcript:

Greg Kunst: We presented on what could be a potential to be a major game change in the way that we treat corneal endothelial disease here in the United States around the world. We're doing this with cell therapy. Cell therapy could cure blindness and restore vision to potentially 16 million people in the US, Europe and Japan affected by corneal endothelial disease. It's a potential game changer for 4 simple reasons.

One, it's an injection of cells, and therefore can be used by a broad spectrum of ophthalmologists around the world, dramatically increasing the number of treaters available for corneal endothelial disease.

Two, it uses natural human endothelial cells, because of that, the safety profile is quite pristine, potentially allowing us to move this treatment earlier in the treatment paradigm.

Third, it's already been proven. We've done this drug now, in over 100 patients with some of those patients with 5 more years of experience in 4 different trials in Japan and in El Salvador. We know the drug works.

Fourth and most importantly, it scales. Unlike today, where we need a donor for every person treated for corneal endothelial disease, with every donor with a part in cell therapy, we get 100 treatments today. In the future, you know, 1 to 1,000, maybe 1 to 10,000. This all has all the hallmarks to be the really the next great innovation in ophthalmology.

We know there are about 13 million people around the world that are corneally blind. And usually one of the primary reasons that we see corneal blindness is the lack of available corneal tissue around the world. Even in the United States, we reserve corneal surgical transplant really for the worst patients. And because of this, we believe that we can reach many more patients with corneal endothelial disease, including Fuchs dystrophy or post keratopathy.

Certainly, it's an area where lots of people are untreated. In the future, pending approval, we'll have a way to treat patients earlier in their disease.

So our next stage is to enter trials in the United States. Obviously the clinical trial process takes time. This is a rare technology because of the prior clinical data, generated in Japan and El Salvador, we know it works. Now it's the test of time of clinical trials, and at the end of these trials, we are hopeful, optimistic, that we'll be able to get approval from the FDA and many other regulators around the world.

Content has been edited for clarity.