Trial Profile

A Confirmatory Trial assessing single intracameral injection of cultured corneal endothelial cells

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 07 Apr 2023

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At a glance

Drugs Neltependocel (Primary)
Indications Corneal disorders
Focus Therapeutic Use

Most Recent Events

07 Apr 2023 New trial record
23 Mar 2023 Results published in the Aurion Biotech Media Release
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.

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