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Pixium retinal implant approved for human trial

24 Oct 2017

French regulatory authority allows feasibility study for treatment of advanced dry age-related macular degeneration.

Paris-based Pixium Vision has received clearance from health authorities in France for a trial of its potentially sight-restoring new retinal implant, known as “PRIMA”.

The company, which raised €15 million in venture finance in 2013 before completing a €34.5 million initial public offering (IPO) on the Euronext stock exchange the following year, says that the wireless device will be tested on patients suffering from advanced dry age-related macular degeneration (AMD).

AMD is the leading cause of blindness in the developed world, and impacts the central area of vision by damaging the area of the retina – the macula – that has the highest concentration of cone cells and is responsible for high-resolution, color vision.

Other bionic retinal implants, for example the “Argus II” device developed by US-based Second Sight, have also been tested in clinical trials.

378 electrodes
Pixium describes the PRIMA device as its “next-generation miniaturized sub-retinal implant”, and says that the approach it uses was first conceived at Stanford University in the US.

Just 2 mm across and 30 µm thick, the photovoltaic PRIMA implant features 378 electrodes. Implanted under the retina, it converts pulsed near-infrared light received via external glasses fitted with an integrated mini-camera into electrical signals transmitted to the brain via the optic nerve.

Khalid Ishaque, Pixium’s CEO, said in a company release: “PRIMA enters an exciting phase of its development, with a first patient expected to be implanted before year-end.”

Entitled “feasibility study of compensation for blindness with the PRIMA system in patients with dry-AMD”, the study is designed to evaluate the tolerance of PRIMA and to demonstrate a level of central visual perception among patients who have lost their sight due to atrophic advanced dry-AMD.

The plan is to recruit five patients, with interim evaluation at a six-month follow-up before a fuller evaluation after three years. The study will be conducted at Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in Paris, with vitreoretinal surgeon and ophthalmologist Yannick Le Mer as principal investigator.

Pixium says that it is also in discussions with the US Food and Drug Administration (FDA) about a similar feasibility study with PRIMA in the country.

Coincidentally, Second Sight recently received conditional approval from the FDA to test its new “Orion” implant on up to ten patients at US hospitals in Los Angeles and Houston. Like Pixium, the Sylmar, California, company is hopeful of implanting the first patient with its Orion prosthesis before the end of this year.

Equity line agreed
Meanwhile, Pixium said last month that a six-month follow-up study of patients who have had the company’s “IRIS II” device implanted to treat retinitis pigmentosa showed that the prosthesis had a shorter life span than expected.

Although one patient had received a replacement, Pixium said that it had “temporarily halted” new implantations, and was looking at the possibility of using a different surgical method.

The ageing global population means that the more than 4 million people thought to be suffering from AMD currently - and without an effective, approved treatment option - is a number set to grow significantly.

The potential for sub-retinal implants to solve that major unmet clinical need has attracted a handful of venture capitalists and other investors to the emerging field – although they will need to tolerate significant losses during the extensive period of clinical trials before enjoying any financial return.

Pixium, which posted a net loss of €6.4 million on revenues of only €1.3 million in the first half of 2017, says that it has just established a new line of equity financing with investor Kepler Chevreux.

The deal could see an additional €6.2 million invested in Pixium over the next two years, with CEO Ishaque saying that the agreement “secures the company’s medium-term financial requirements under flexible conditions”.

As of June 30 this year, Pixium held €14.9 million in cash and equivalents.

AVANTES BVSynopsys, Optical Solutions GroupRoithner Lasertechnik GmbHSpectrum Scientific Inc. -  SSI OpticsSchaefter und Kirchhoff GmbHEaling UGAltechna
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