Health & Beauty

Pixium Vision Gets Clinical Trial Approval from Spanish Ministry of Health for 150 Electrode IrisII Bionic Vision System

Pixium Vision has received approval from the Spanish Ministry of Health for clinical trial with the IRISII bionic vision system for patients who have lost sight due to Retinitis Pigmentosa (RP).

According to a release, the IRISII system features include a mini bio-inspired camera and a 150-electrode epi-retinal implant with an explantable design.

Barcelona's Institute of Ocular Microsurgery IMO (Spain) joins the expanding network of centres of excellence in Europe involved in the clinical trial with IRISII. The Institute of Ocular Microsurgery is a ophthalmology center dedicated to the treatment of ocular diseases and the correction of vision. Patients in Spain will have the opportunity to participate in this European clinical trial.

Prof. Borja Corcostegui, Founder and Medical Director of the Institute of Ocular Microsurgery, IMO, a vitroretinal surgeon and the trial's principal investigator in Spain, said: "We are delighted to participate in the clinical trial with IRISII and become the first site in Spain. Patients blind from outer retinal degeneration in Spain can consider participation in assessing the innovative bionic vision system designed to regain a form of visual perception. Participation in clinical trials with innovative treatment options is essential for ophthalmology reference centres such as IMO. The partnership with Pixium Vision to develop solutions for retinal dystrophies, such as RP and, in the near future, Age-related Macular Degeneration (AMD), is consistent with our continuous commitment to offer cutting-edge treatment options to our patients."

Khalid Ishaque, CEO of Pixium Vision, said: "The approval of the clinical trial now in Spain reinforces our confidence in the IRISII, our first bionic vision system. Today, Pixium Vision is the only company developing an epi-retinal implant system for retinitis pigmentosa, and a sub-retinal wireless photovoltaic implant for AMD patients. We are proud to initiate this clinical collaboration in Spain with the internationally renowned Institute of Ocular Microsurgery, IMO."

In July 2016, Pixium Vision also received EU market approval for IRISII. Available under medical prescription, the bionic vision system offers a new treatment option to patients with retinitis pigmentosa. The Company can now also pursue reimbursement with the national healthcare systems. The ongoing prospective multi-centre clinical study protocol being conducted across several European ophthalmology reference centres, further enables building longer term evidence for the system performance.

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  • Alexandra Scarborough
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