Aurion Biotech has dosed the first participant in its Phase I / II clinical trial of cell therapy AURN001 to treat patients with corneal oedema secondary to corneal endothelial dysfunction in the US.
The randomised, multicentre, parallel-arm, double masked, dose-ranging ABA-1, CLARA trial will evaluate the tolerability, safety, and efficacy of AURN001.
It will assess three varying doses of AURN001 in nearly 100 subjects at trial sites in the US.
The percentage of participants who attain three lines of vision at six months is the primary endpoint of the trial.
A combination cell therapy product, AURN001 includes allogeneic human corneal endothelial cells (CECs), neltependocel, and Y-27632.
The cell therapy should be delivered to the eye as a single intracameral injection.
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Aurion Biotech president and chief medical officer Michael Goldstein said: “On the heels of our recent approval in Japan, we are very pleased to have begun dosing subjects in this trial in the US.
“The start of this trial is another important milestone in our goal of bringing this corneal endothelial cell therapy to millions of patients in need throughout the world.
“We believe that cell therapy has the potential to revolutionise the treatment of corneal patients.”
A sight-threatening condition, corneal oedema secondary to endothelial dysfunction is caused by the loss of corneal endothelial cells that leads to oedema and vision loss.
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