Research & Development
Aurion Biotech granted FDA Breakthrough and RMAT designations for AURN001
19 June 2024 -

Aurion Biotech, a clinical-stage biotech company aiming to restore vision to millions of patients with regenerative therapies, announced on Wednesday that AURN001, an allogeneic cell therapy for corneal edema, has secured both Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA).

AURN001 is the first therapy of its kind to achieve this dual designation for the treatment of corneal edema secondary to corneal endothelial disease.

BTD expedites development for treatments with promising clinical data, while RMAT recognizes the potential of regenerative therapies for unmet medical needs. These designations aim to accelerate AURN001's path to market, leveraging positive results from ongoing Phase 1/2 trials.

AURN001 has already received regulatory approval in Japan.