Aurion Biotech is a clinical-stage biotech developing a cell therapy for corneal endothelial disease, a condition where the innermost layer of the cornea degrades, eventually causing blindness. The standard of care today is corneal transplant surgery, which is complex, supply-constrained, and underutilized — only about 11% of diagnosed patients in the U.S. receive treatment. Aurion's lead product, AURN001, is an injection of allogeneic corneal endothelial cells combined with a ROCK inhibitor (a compound that promotes cell survival and adhesion) directly into the eye. The cells then re-form the endothelial layer on the back of the cornea. Compared to transplant surgery, the procedure is simpler and requires only about three hours of face-down recovery versus multiple days. Aurion's first-generation product, Vyznova, launched commercially in Japan in September 2024, and is, by Aurion's account, the only approved pharmacological therapy for this disease anywhere in the world. AURN001 is an improved formulation with better manufacturing scalability and longer shelf life, and currently carries FDA Breakthrough Therapy and RMAT designations. It is in a Phase 1/2 U.S. trial, with 12-month data expected in the second half of 2025. The business model is a per-dose drug sale, with Aurion claiming the ability to produce over 1,000 doses from a single donor cornea — a key manufacturing advantage over the one-donor-per-patient requirement of transplant surgery. Aurion sells Vyznova in Japan through a distributor and plans to build a direct U.S. sales force targeting corneal specialists, cataract surgeons, and glaucoma specialists.