AURN001 receives breakthrough therapy, regenerative medicine advanced therapy designations
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Key takeaways:
- AURN001 is an allogeneic cell therapy candidate for the treatment of corneal edema secondary to corneal endothelial disease.
- The designations should expedite development of the cell therapy.
The FDA granted breakthrough therapy and regenerative medicine advanced therapy designations for AURN001 for the treatment of corneal edema secondary to corneal endothelial disease, according to a press release from Aurion Biotech.
“Breakthrough therapy and regenerative medicine advanced therapy designations are an important win for the millions of people suffering from corneal endothelial disease,” Greg Kunst, CEO of Aurion Biotech, told Healio. “These designations enable Aurion to work more closely with the FDA on our clinical development plans, which, we believe, should help us to accelerate our progress.”
The FDA granted the designations based on AURN001’s potential to address unmet medical need in patients with corneal endothelial disease and a review of clinical data from the AURN001 program, including multiple clinical trials with subjects having at least 12 months of follow-up.
As Healio previously reported, Aurion completed enrollment and dosing in its phase 1/2 CLARA trial in the U.S. and Canada to investigate safety, tolerability and efficacy of AURN001 for corneal edema secondary to corneal endothelial dysfunction.
AURN001 previously received regulatory approval in Japan.
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