First-in-Human Trial to observe safety of a single intracameral injection of cultured corneal endothelial cells
Latest Information Update: 07 Apr 2023
At a glance
- Drugs Neltependocel (Primary)
- Indications Corneal disorders
- Focus Adverse reactions; First in man
- 07 Apr 2023 New trial record
- 23 Mar 2023 According to Aurion Biotech media release, based on the treatment of 65 subjects across three clinical trials conducted in Japan, including: a First-in-Human Trial (n=38); Endothelial Cell Dose Ranging Trial, (n=15); and a Confirmatory Trial (n=12) the company has received regulatory approval from Japans Pharmaceuticals and Medical Devices Agency (PMDA) for its novel cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea.
- 23 Mar 2023 Results published in the Aurion Biotech Media Release