Medgadget previously reported on a preclinical trial by Pixium Vision, a company based in Paris, France, showing that its visual implants restore sight in rats with retinal degeneration. Pixium Vision is making headlines again with a recent announcement that the UK regulatory authority, Medicines & Healthcare products Regulatory Agency (MHRA), has granted clinical trial approval for Pixium Vision’s 150 Electrode IRIS II bionic vision system. The IRIS II system consists of a bio-inspired camera, which mimics human eye function by continuously acquiring images of a changing visual scene, and an epi-retinal implant made of 150 electrodes that are explantable, thereby facilitating future therapeutic upgrades.
The UK approval of the clinical study marks the initiation of a clinical partnership with Moorfields Eye Hospital, who now join the clinical trial as the first UK site. The clinical trial evaluates the safety and efficacy of IRIS II in patients with retinal dystrophy, including retinitis pigmentosa. Pixium Vision has also applied for CE mark approval, which if granted will allow commercialization activities to begin later this year.
IRIS II clinical trial: Ref: NCT02670980
Source: Pixium Vision