Retinal implant for retinitis pigmentosa gets green light

Following UK and German trials, the Alpha AMS retinal implant is approved for use in Europe

X-ray of retinal implant

A new sub-retinal electronic implant available in Europe should spark the interest of retinitis pigmentosa (RP) patients.

The Alpha AMS, developed by German company Retina Implant AG, has received its CE mark, allowing it to be marketed in Europe for patients with severe sight loss from RP.

The microchip, which has 1600 pixels, detects light entering the eye. The system allows the patient to utilise their eye movements to view the world around them.

It then transfers the received light signals to the remaining optic nerve cells in the RP patient’s eye to send the information to the brain, to be interpreted as sight.

The device was developed by German university researchers, and has been tested in clinical trials at the University of Oxford, alongside a number in Germany.

University of Oxford ophthalmologist, Professor Robert MacLaren, found that both patients receiving the implant experienced some restoration of functional vision.

The Alpha AMS is wirelessly powered and is expected to last several years in the eye.

Retina Implant AG chief executive, Dr Walter-Gerhard Wrobel, told OT that the implant cost €95,000 (£76,000), including training for the patient by engineers.

“Hospital care adds another €20,000–30,000 (£16,000–£24,000). The German public health care system reimburses this operation under certain conditions … [but] in the UK, there is no reimbursement yet. Retinal prostheses are considered to be experimental treatments,” he explained.

The NHS specialised ophthalmology services clinical reference group was currently evaluating the funding of retinal implants.

Dr Wrobel said that the patients enrolled in the clinical trial have been critical to the success of the device to date.

“We look forward to making our technology commercially available to the patient community across Europe,” he emphasised.

The AMS’s predecessor, the Alpha IMS, received its CE mark in 2013.

Image credit: University of Oxford