Corneal oedema resulting from endothelial dysfunction is a serious condition that threatens vision and affects millions of people globally. Credit: 4 PM production / Shutterstock.com.

Aurion Biotech has dosed the first Canadian subject in the Phase I/II ABA-1, CLARA clinical trial of AURN001, a new cell therapy aimed at treating corneal oedema due to corneal endothelial dysfunction.

The therapy combines neltependocel, allogeneic human corneal endothelial cells (CECs) with Rho-associated, coiled-coil containing protein kinase (ROCK) inhibitor, Y-27632.

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The treatment involves a one-time, intracameral injection directly into the eye.

ABA-1, CLARA is designed to evaluate the tolerability, safety, and efficacy of AURN001 to treat patients with corneal oedema secondary to corneal endothelial dysfunction.

The prospective, multicentre, double-masked, randomised, parallel-arm cell dose-ranging study will analyse three varying doses of neltependocel used in combination with Y-27632 in approximately 100 subjects.

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Trial subjects will be randomised to receive the treatment across various sites in Canada and the US.

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The percentage of participants who experience a three-line gain in vision after six months is the trial’s primary endpoint.

Corneal oedema resulting from endothelial dysfunction is a serious condition that threatens vision and affects millions of people globally.

Aurion Biotech president and chief medical officer Michael Goldstein said: “We are very pleased to have begun dosing subjects in this trial in Canada.

“Treating subjects in both the US and Canada in our CLARA trial is an important milestone in our clinical development programme. We believe that our cell therapy has the potential to revolutionise the treatment of corneal patients throughout the world.”

The company had received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its Vyznova cell therapy to treat bullous keratopathy of the cornea, in March last year.

In April 2022, Aurion Biotech raised $120m in a funding round from various biotech and ophthalmology investors to advance the development of its cell therapy programme for corneal oedema secondary to endothelial dysfunction.