UK Regulatory Authority Approves Clinical Trial result for Pixium Vision’s Bionic Vision System

Pixium Vision announced that it has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK to initiate a clinical trial for patients who have lost sight due to retinitis pigmentosa (RP) with the IRIS® II bionic vision system. This system being evaluated includes a mini bio-inspired camera and a 150 electrode epi-retinal implant with an explantable design.



Participation of Moorfields Eye Hospital NHS Foundation Trust broadens the clinical study centres of excellence in addition to sites across France, Germany and Austria. Moorfields Eye Hospital is the oldest and largest centre for ophthalmic treatment, teaching and research in Europe. Additional clinical centres across Europe enables broader patient outreach, increased opportunity to participate in the clinical trial, and paves the way for future commercialisation of the bionic vision system.

In parallel, Pixium Vision initiated last December CE mark approval process on the basis of IRIS clinical experience. Subject to CE mark approval timing, commercialisation is expected to start in H2 2016.

More details can be found from Pixium Vision website.