France’s Pixium Vision announced Jan. 13 that 10 patients have been implanted with its Iris II retinal prosthesis as part of an ongoing study.
The epiretinal 150-electrode implant is intended to compensate for blindness in patients with retinitis pigmentosa. It received CE marking in July 2016.
The IRIS II clinical trial, initiated in January 2016, is a multicenter, open-label, non-randomized prospective European study to assess effectiveness of the IRIS II as a treatment to compensate for blindness by providing a form of perception for blind individuals.
The trial is being conducted in ophthalmology centers in France, the UK, Spain, Austria, and Germany.
The company plans to provide interim updates later in 2017.
Pixium is seeking reimbursement approval for the Iris II and is currently working with public reimbursement authorities in France and Germany.
Pixium is also seeking US regulatory approval and has scheduled discussions with the FDA to define a US clinical study timeline, the company said in November.
