Aurion Biotech, a Seattle-based company recently announced that it has been granted special designations by the US Food and Drug Administration (FDA) to expedite the development of its treatment for corneal edema, a prevalent condition that can result in vision loss. Aurion's cell therapy treatment was conferred regenerative medicine advanced therapy designation and breakthrough therapy designation by the FDA. Endothelial dysfunction is the consequence of corneal edema, which is induced by the cornea's degeneration as a result of age or disease. This condition, which is defined by impaired and hazy vision, impacts millions of individuals worldwide, with approximately 4% of individuals over the age of 40 in the US being affected. A Phase 1/2 clinical trial that is being conducted in the US and Canada was recently concluded by Aurion, with the enrollment of 97 patients. It should be noted that the cell therapy has already been approved for use in Japan.
Current remedies for corneal edema include corneal transplants, which, although effective, are constrained by a scarcity of available tissue and a rigorous postoperative recovery period. In order to guarantee appropriate corneal adherence, patients are obligated to remain in a flat position on their backs for a maximum of three days. Aurion announced a $120 million Series C round of financing in 2022, which was a testament to the strong confidence of investors in its innovative approach. Aurion Biotech is in a favorable position to advance its promising cell therapy treatment, which has the potential to provide a more accessible and less burdensome option for those suffering from corneal edema, as a result of the FDA's fast-track designations.
