Pixium Sees A Bright Future In Europe

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Includes: EYES
by: EP Vantage

Pixium Vision is a distant second to market with its Iris II retinal implant for retinitis pigmentosa: Second Sight’s (NASDAQ:EYES) Argus II has been available in Europe since 2011. But with more than twice as many electrodes the Iris II could permit patients better vision than the competing device.

Reimbursement is the next challenge for Pixium, and with a price point of around €95,000 and a fragmented European landscape this will be tricky. Pixium’s chief executive Khalid Ishaque describes the uptake of Second Sight’s rival product as “frankly disappointing” – but can Pixium do any better?

Like its rival, the Iris II system consists of a pair of goggles containing a camera, which transmits data wirelessly to a retinal implant. The implant contains an electrode array which stimulates the optic nerve and generates images. It is a second-generation device: the company set aside its initial project, the Iris I, when it became clear that patients expected better.

Light out of darkness

Iris II was CE marked based on data on Iris I and interim six-month findings from an ongoing 10-patient European trial, Iris 2, which is not due to report fully until 2022 according to clinicaltrials.gov.

The retinitis pigmentosa (RP) patients Pixium aims to treat have no vision at all. “After a year or 18 months they are able to identify shapes, objects, obstacles,” Mr Ishaque says. “We’re creating a pattern which they learn to recognise.”

The Iris II system does appear to be a technological level above the Argus II. With 150 electrodes to Argus II’s 60 and a more advanced camera – based on technology used to capture the Higgs boson at the Large Hadron Collider – for a similar price.

It also has another advantage: it can be surgically removed and therefore in theory could in future be upgraded with newer technology. This could be a big selling point as RP tends to manifest when patients are in their 30s and vision can deteriorate very quickly. Relatively young patients will find a device that can be improved over time very appealing.

Payers, of course, are another matter. But RP is a rare disease with no effective therapies, so Pixium may be able to make an argument that expensive treatments ought to be permitted. And profoundly blind patients come with a cost already: Mr Ishaque says each patient costs the healthcare system around €30,000-40,000 per year.

Second comes right after first

Second Sight’s Argus II is already on sale in the US as well as Europe and Pixium has five years of catching up to do. Second Sight reported that 75 Argus IIs – its only product – were implanted in 2015 and 29 the year before. Its total 2015 revenue was $8.9m.

Pixum is still some years from the US market. The group intends to seek FDA permission to begin a US study by the end of this year. But it has a strategic decision to make.

The company now has a new product that might be a better bet for the US market. Called Prima, it is designed to address a different condition: the much more common age-related macular degeneration.

“We have in parallel a subretinal, even further miniaturized, implant which is targeting AMD,” Mr Ishaque says. He says it could enter a first feasibility study in Europe by the end of this year. According to analysts from Jefferies, there is an addressable market of four million AMD patients in the US and Europe.

If Pixium goes after RP, however, the Jefferies analysts suggest that a 3% share of eligible blind RP patients implies worldwide sales of $100m. Considering that Second Sight’s device has been on sale in Europe for five years and in the US for three without managing a tenth of that, $100m might be optimistic.

But Pixium is hopeful that when full data from Iris II’s current clinical trial are in it may be able to claim superiority to the Argus II. This claim would certainly help it reach that $100m milestone; without it, it could have difficulty catching up with Second Sight.

Trial name

Trial ID

Iris 2

NCT02670980