Pixium Vision, a company developing innovative bionic vision systems to allow patients who have lost their sight to lead more independent lives, 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.
Mahi Muqit, PhD FRCOphth, Consultant Ophthalmologist and Vitreoretinal Surgeon at Moorfields Eye Hospital, study Principal Investigator (UK) said, "We are excited to participate in the clinical trial of IRIS®II and be the first site in the UK. Patients with RP can now benefit from a new choice of retinal implant that may potentially further improve visual outcomes.
"This new clinical trial is key for ophthalmic reference centres like Moorfields to evaluate the latest technologies, and provide patients with a retinal implant that is differentiated and allows retinal implant exchanges in the future. We are delighted to work with Pixium Vision to develop solutions for retinal dystrophies like RP and age-related macular degeneration (AMD)ý."
Commenting on the announcement, Khalid Ishaque, CEO of Pixium Vision said, "The UK approval for the clinical study further reinforces our confidence in the IRIS®II platform, our first innovative bionic vision system." Khalid Ishaque added.
"Currently as the only company developing an epi-retinal system for RP patients and a sub-retinal wireless photovoltaic implant for AMD patients, we are delighted to initiate this clinical partnership with the world renowned Moorfields Eye Hospital in the UK."
IRIS® II epi-retinal system incorporates innovative features being evaluated, including:
A bio-inspired camera that is intended to mimic the functioning of the human eye: the imaging sensor does not take sequence of video frames with redundant information, but continuously captures the changes in a visual scene with its time independent pixels;
An epi-retinal implant with 150 electrodes, almost three times more electrodes than available previously;
An explantable design: the electrode array is secured on the retinal surface by a patented support system that allows to explant, minimising risk of retinal damage and permitting potential for upgrade to newer therapy options.
The IRIS® II clinical trial is a multi-centric, open label, non-randomized prospective European study to assess safety and performance of the IRIS® II bionic vision system as treatment to compensate for blindness, providing a form of perception for blind persons and enabling them greater autonomy and quality of living.
Up to 10 patients suffering from retinitis pigmentosa, Usher Syndrome, Cone-Rod dystrophy, choroideremia will be included and followed for a minimum of 18 months, with additional 18 months follow-up, subject to patient consent.