EP Vantage interview – Pixium Vision sets its sights on approval

Interviews

There is little more dramatic in medicine than the idea of bringing sight to the blind. This is perhaps what has spurred the €15m ($20.3m) funding round Pixium Vision has just completed. The French company intends to spend the cash on clinical trials of its IRIS1 retinal implant, designed to treat retinal degradation patients, with the aim of obtaining CE mark next year.

The company is simultaneously working on second and third-generation versions of the implant, which could be necessary to compete effectively with its main rival, Sylmar, California-based Second Sight. But Pixium’s chief executive, Bernard Gilly, says that results with its IRIS1 and follow-on products are “absolutely” better than anything Second Sight can muster.

Breakthrough

Pixium’s IRIS system is intended to treat patients who have lost their sight entirely through degenerative conditions of the eye, such as retinitis pigmentosa and macular degeneration. It consists of an intraocular implant attached to the surface of the retina. The patient wears a pair of goggles containing a camera, which transmits data wirelessly, via a pocket computer, to the implant. In turn, the implant stimulates the optic nerve and generates images.

Patients must undertake a rehabilitation programme to learn to interpret the signals they receives from the implant. But Mr Gilly tells EP Vantage that this is an advantage in that it allows the software used in the device to be tailored to each individual patient.

“It’s a learning process. The patient is able to have more precise perception much more rapidly than with the Second Sight device,” he says. “In the five patients implanted so far in our trial, a few minutes after the device has been switched on, they can do tasks that would take several weeks with the Second Sight device.”

Second Sight is, despite its name, first: the Argus II was CE marked in 2011 and the company swung US approval for the product under a humanitarian device exemption in February (US approvals of innovative devices halve, July 29, 2013).

The 12-patient clinical trial of Pixium’s first iteration, IRIS1, began in April. Data from the first patients to receive the implant are expected in 2014 and will form the basis of a CE mark application.

That will lead in to the second generation product, called IRIS2, Mr Gilly says. “IRIS1 will be CE marked in 2014 and we are developing a new one with 150 electrodes – three times as many as the Second Sight product. IRIS2 will use the CE mark of IRIS1 as it’s really very much the same technology – we’ve discussed this with the notified body we are working with, and they say that because it’s very similar, they will not require additional trials.”

A third-generation implant is also under development, that Pixium claims has much greater potential for restoring sight.

It is the IRIS2 version that the company is aiming at the US market, Mr Gilly says. “We are going to approach the FDA for IRIS2, to find out what they want to see with clinical trials – number of patients and duration of implantation – and plan to go for a PMA or a 510(k).”

He says that Pixium is eschewing the HDE route as the company will be able to show better clinical results than its rival.

If it can indeed prove more effective, there will be an argument for pricing IRIS2 at a premium to Argus II. Second Sight’s product is reimbursed at €80,000 in Germany and $144,000 in the US.

Public?

The €15m series A extension round that will fund this exciting future was led by Sofinnova Partners, now Pixium’s largest investor. Bpifrance and the InnoBio fund also participated, along with previous investors Omnes Capital and Abingworth.

Speaking to EP Vantage in October, Tim Haines, a partner at Abingworth, called Pixium’s system “a really huge dramatic breakthrough technology that we’re very excited with.” He added that the company “could be an IPO candidate in the French market inside the next year or so.”

Mr Gilly played this idea down. “We will not IPO without strong data that will demonstrate that our system works better than rival systems. But yes, if the market is bullish about medtech, we will probably take this company public. There are still conditions to be met. But one day.”

To contact the writer of this story email Elizabeth Cairns in London at elizabethc@epvantage.com or follow @LizEPVantage on Twitter

Share This Article