First human trial confirmed for sub-retinal implant

The first of its kind human trials will involve five patients who have lost their sight due to atrophic advanced dry-AMD using the company’s miniaturised wireless sub-retinal implant. The study will evaluate the tolerance of PRIMA and measure the evoked central visual perception of the patients, with an interim evaluation at six months, followed by a long-term follow-up at 36 months.{{quote-a:r-w:400-I:2-Q:“The approval of the clinical study is a significant advance for the PRIMA syst, our next generation wireless sub-retinal implant syst, as well as for Pixium Vision,”-WHO: Khalid Ishaque, Pixium Vision CEO}}“The approval of the clinical study is a significant advance for the PRIMA syst, our next generation wireless sub-retinal implant syst, as well as for Pixium Vision,” CEO Mr Khalid Ishaque said.“PRIMA enters an exciting phase of its development, with a first patient expected to be implanted before year end. With ageing population dynamics, advanced dry-AMD is a leading cause of irreversible vision loss with currently estimated over four million people without an approved treatment option making it a significant unmet medical need, Ishaque added.The trials will be conducted by ophthalmologist and vitreoretinal surgeon Dr. Yannick Le Mer of the Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in Paris, France.The PRIMA wireless sub-retinal implant bionic vision syst is a next-generation miniature wireless micro photovoltaic chip, measuring two millimetres wide and three microns thick. It is equipped with 378 electrodes and implantable via a less-invasive surgical operation.The implant converts pulsed near infra-red invisible light signal received from the external glasses with an integrated mini-camera into electrical signals transmitted to the brain via the optic nerve.Pixium Vision is currently in negotiation with the US Food and Drug Administration for possible trials of PRIMA in the US.