IRIS II, a bionic eye system developed by Pixium Vision, is to be clinically trialled at Moorfields Hospital in the United Kingdom and, subject to CE mark approval, may move into commercialisation within months.
The IRIS II, which is equipped with a bio-inspired camera and a 150 electrode epi-retinal implant with an explantable design, will be implanted in patients who have lost sight due to retinitis pigmentosa (RP).
Participation of Moorfields Eye Hospital NHS Foundation Trust broadens the clinical study which is currently underway in sites across France, Germany and Austria.
The IRIS II epi-retinal system being evaluated incorporates:
- 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.
Speaking of the trial, Dr. Mahi Muqit, 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).”
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. 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.”
Pixium filed for CE mark approval of the IRIS II in Europe at the end of 2015, following which, it plans to initiate commercial operations. An initial roll-out is planned for Europe, leveraging sites participating in the clinical trials. The second phase will be the selective commercial roll-out across other geographies, particularly where CE level certification is equivalent to relevant national ministry of health regulatory requirements, and reimbursement is available.
