French retinal implant maker Pixium Vision said today it won U.K. Medicines & Healthcare products Regulatory Agency approval to initiate a clinical trial of its Iris II bionic vision system designed to restore sight to patients with retinitis pigmentosa.
The Iris system is comprised of a retinal implant and a pair of camera-mounted glasses connected to a “pocket computer.” The computer processes images captured by the glasses and transmits the data into a signal that’s transferred back and projected onto the intraocular implant, where it stimulates the optic nerve and generates images that the brain learns to interpret as visual signals.
“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,” study principal investigator Mahi Muqit of the U.K.’s Moorfields Eye Hospital said in a press release.
The French company said that it initiated the CE Mark approval process in December based on previous Iris clinical trials, and expects to commercialize the device in the 2nd half of 2016, if approval is achieved.
“The UK approval for the clinical study further reinforces our confidence in the IRISII 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,” CEO Khalid Ishaque said in a prepared statement.
In February, Pixium announced the 1st implantation and successful activation of its Iris II epi-retinal implant designed for patients with vision loss as a result of retinitis pigmentosa.
The 1st implant took place in January and was performed by Michel Weber of France’s University Hospital of Nantes, the company said. Up to 10 patients are slated to be included in a clinical trial of the device, according to Pixium Vision.