Clinical Trials

Date: 2017-05-09

Type of information: Treatment of the first patient

phase: 1-2

Announcement: treatment of the first patient

Company: Eyevensys (France)

Product: EYS606

Action mechanism:

gene therapy. EYS-606 is a soluble TNFa receptor plasmid. This non-viral gene therapy is based on Eyevensys’ EyeCET technology, which uses a proprietary electro-transfection injection system (ETIS) to deliver a plasmid encoding for the production of an anti-TNF? therapeutic protein into the ciliary muscle of the eye. TNF? is a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation in non-infectious uveitis (NIU) patients.
EYS606 has been granted an Orphan designation by the EMA for the treatment of NIU.

Disease: non-infectious uveitis (NIU)

Therapeutic area: Rare diseases - Ophtalmological diseases

Country: France, UK

Trial details:

The phase I/II trial aims to demonstrate the safety and tolerability of the EYS606 treatment when the plasmid component of EYS606 is administered using EyeCET technology by electro-transfer into the ciliary muscle of patients with non-infectious posterior, intermediate or pan uveitis. The treatment procedure, which takes less than 5 minutes, is designed to provide the patient with a local, safe and sustained treatment, obviating the need for monthly injections. This open-label, multicentre dose escalation study will enrol up to 24 patients in France and the UK and the initial trial results are expected in the first half of 2018. (NCT03308045)

Latest news:

• On May 9, 2017, Eyevensys announced that it has successfully treated the first patient in a first-in-human phase I/II trial of its lead candidate EYS606 for Non-Infectious Uveitis (NIU). The patient was treated in Paris, France at the Cochin Institute by Professor Antoine Brézin, the principal investigator of the trial, using the company’s novel EyeCET technology.
• On April 20, 2017, Eyevensys announced it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to advance its technology into clinical development.
• On April 11, 2017, Eyevensys announced it has received approval from the French product security regulatory agency “Agence Nationale de Sécurité du Médicament” (ANSM) to advance its technology into clinical development.