Aurion Biotech
Aurion Biotech is a clinical-stage biotech company dedicated to restoring vision to millions of patients through innovative, accessible, and effective advanced therapies. Their first candidate is a patented cell therapy treatment for corneal endothelial disease, with a mission to develop life-changing regenerative therapies. The company has received regulatory approval in Japan for their treatment VyznovaTM and is advancing clinical trials in the US and Canada. Backed by leading investors, Aurion Biotech aims to revolutionize the treatment of corneal diseases with their innovative cell therapy platform. With offices in Seattle, Boston, and Tokyo, they are committed to developing life-changing regenerative therapies for eye diseases.
Industries
Nr. of Employees
small (1-50)
Aurion Biotech
701 Pike Street, Suite 2225, Seattle, WA 98101
Products
Commercial allogeneic corneal endothelial cell therapy (approved in Japan)
An off-the-shelf allogeneic corneal endothelial cell therapy manufactured from donor corneas using a multi-step culture process and intended for intracameral administration to treat corneal endothelial dysfunction.
Investigational combination corneal endothelial cell therapy with rho-kinase inhibitor
Investigational combination product comprising allogeneic corneal endothelial cells and a rho-kinase inhibitor intended for intracameral administration; evaluated in Phase 1/2 randomized, dose-ranging trials.
Cryopreserved corneal endothelial cell formulation (developmental)
Pilot clinical evaluation of a cryopreserved formulation of corneal endothelial cells to support alternate storage and distribution strategies.
Commercial allogeneic corneal endothelial cell therapy (approved in Japan)
An off-the-shelf allogeneic corneal endothelial cell therapy manufactured from donor corneas using a multi-step culture process and intended for intracameral administration to treat corneal endothelial dysfunction.
Investigational combination corneal endothelial cell therapy with rho-kinase inhibitor
Investigational combination product comprising allogeneic corneal endothelial cells and a rho-kinase inhibitor intended for intracameral administration; evaluated in Phase 1/2 randomized, dose-ranging trials.
Cryopreserved corneal endothelial cell formulation (developmental)
Pilot clinical evaluation of a cryopreserved formulation of corneal endothelial cells to support alternate storage and distribution strategies.
Services
Design and conduct of multi-center, randomized, double-masked dose-ranging clinical trials with on-site coordination, specialized ophthalmic procedures and multi-regional investigator engagement.
Process development, analytical method development, formulation (including cryopreserved formats) and GMP manufacturing services for corneal endothelial cell therapies provided through internal capabilities and partnerships.
Design and conduct of multi-center, randomized, double-masked dose-ranging clinical trials with on-site coordination, specialized ophthalmic procedures and multi-regional investigator engagement.
Process development, analytical method development, formulation (including cryopreserved formats) and GMP manufacturing services for corneal endothelial cell therapies provided through internal capabilities and partnerships.
Expertise Areas
- Clinical trial management
- Ophthalmic cell therapy development
- CMC and GMP manufacturing scale-up
- Regulatory strategy and multijurisdictional submissions
Key Technologies
- Allogeneic adherent cell culture and expansion
- Intracameral delivery of cell therapies
- Cryopreservation of cell therapy formulations
- Combination biologic and small-molecule product development
News & Updates
Key leadership appointment to accelerate clinical development of AURN001.
Recognition for their innovative cell therapy platform.
First-ever regulatory approval in the world for an allogeneic cell therapy for corneal endothelial disease.
Topline data shows statistically significant improvement in vision and corneal thickness with high-dose AURN001.
Prix Galien Award for Best Start-Up in Biotech
Received in 2022 for their innovative cell therapy platform.
Awarded to CEO Greg Kunst for leadership and innovation.
Key leadership appointment to accelerate clinical development of AURN001.
Recognition for their innovative cell therapy platform.
First-ever regulatory approval in the world for an allogeneic cell therapy for corneal endothelial disease.
Topline data shows statistically significant improvement in vision and corneal thickness with high-dose AURN001.
Prix Galien Award for Best Start-Up in Biotech
Received in 2022 for their innovative cell therapy platform.
Awarded to CEO Greg Kunst for leadership and innovation.