Bionic eye clinical trial approved by the MHRA
Pixium Vision’s IRIS II bionic vision system will be used in a clinical trial to help patients who have lost their sight due to retinitis pigmentosa (RP)
Pixium Vision, a company developing bionic vision systems has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a clinical 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.
The Moorfields Eye Hospital NHS Foundation Trust will be taking part in the clinical study that is also taking place in sites across France, Germany and Austria.
Pixium Vision also initiated CE mark approval process last December on the basis of IRIS clinical experience. Subject to CE mark approval timing, commercialisation is expected to start in H2 2016.
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. 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.”