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Tech

First human trials for sub-retinal implant

23/11/2017
Human trials have been approved for a bionic implant designed to restore vision for those affected by retinal dystrophies.

The first of its kind human trials will see five patients, who have lost their sight due to atrophic advanced dry age-related macular degeneration (AMD), use the PRIMA implant from French biotech company Pixium Vision.


"The approval of the clinical study is a significant advance for the PRIMA system."
Khalid Ishaque, CEO of Pixium Vision

The study will evaluate the tolerance of the miniaturised wireless sub-retinal implant 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.

“The approval of the clinical study is a significant advance for the PRIMA system, our next generation wireless sub-retinal implant system, 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.

PRIMA wireless sub-retinal implant bionic vision system
PRIMA wireless sub-retinal implant bionic vision system

Ophthalmologist and vitreoretinal surgeon Dr Yannick Le Mer of the Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in Paris will conduct the trial.

The PRIMA wireless sub-retinal implant bionic vision system 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 infrared invisible light signals 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.

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