Tech & Innovation in Healthcare

Reader Questions:

FDA Awards Designations for Innovative Eye Treatment

Question: As an ophthalmologist, I encounter patients with varying levels of eye health. However, the ones who have unique conditions always pique my interest and make me wish medical professionals could provide them with the treatment they need to enjoy clear vision.

Have there been recent innovations in the field of eye health?

Georgia Subscriber

Answer: Several innovations are currently being researched for vision-related conditions. Here’s one company that comes to mind.

Aurion Biotech, based in Seattle, Washington, recently received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. Food and Drug Administration (FDA) for its development of cell therapy treatment. The cell therapy is designed to treat a common disease that affects the cornea and results in loss of vision.

Corneal edema secondary to endothelial dysfunction is a condition caused by corneal degeneration due to age or disease. Symptoms of the condition include impaired or hazy vision and eventually blindness.

Aurion Biotech’s cell therapy has been approved for use in Japan, and recently the company enrolled 97 patients in Phase 1 and 2 clinical trials in the U.S. and Canada. The FDA designations listed above help speed up the agency’s review process and are handed out to breakthroughs that aid significant diseases or provide substantial improvements over treatment options that are currently available.