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AURN001 (neltependocel + Y-27632)

Corneal Endothelial Disease

Phase 3BTD/RMAT designations granted; U.S. Phase 3 planned Q1 2026

Key Facts

Indication
Corneal Endothelial Disease
Phase
Phase 3
Status
BTD/RMAT designations granted; U.S. Phase 3 planned Q1 2026
Company

About Aurion Biotech

Aurion Biotech is a clinical and commercial-stage biotech focused on eliminating blindness through regenerative cell therapies for ophthalmic diseases. The company's core platform, Corneal Endothelial Cell Therapy (CECT), uses cultivated human donor cells to restore vision, with its lead candidate AURN001 advancing toward a U.S. Phase 3 trial in 2026 and its first product, Vyznova, already approved and sold in Japan. With prestigious designations from the FDA, a strategic majority investment from Alcon, and a leadership team rich in ophthalmology and cell therapy expertise, Aurion is positioned to address a significant global unmet need for millions of patients suffering from corneal endothelial disease.

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Other Corneal Endothelial Disease Drugs

DrugCompanyPhase
Cryopreserved AURN001Aurion BiotechClinical Stage