Just as well that Second Sight’s retinal prosthesis Argus II is already on sale in Western markets as a therapy for blindness. The first human data on its follow-up system, Orion, designed to widen the treatable population, are somewhat lukewarm.
This is an early cut of the results, which might improve with time. But an adverse safety signal is more of a concern, and sent the company’s shares down 9% yesterday. Meanwhile the group’s main competitor, France’s Pixium Vision, is gearing up to start a pivotal trial with its retinal technology, and analysts see this company as the long-term winner.
The Orion device converts video images captured by a camera into electrical stimulation patterns delivered via electrodes implanted in the brain to induce visual perception. Because Orion, unlike Argus II, bypasses the eyes altogether, Second Sight reckons the former could be used in any patient with an undamaged visual cortex; Argus II can only treat blindness due to retinitis pigmentosa.
The Orion Early Feasibility Study saw the device implanted in six patients with various causes of blindness, including eye trauma and glaucoma. Of the five patients who had reached the six-month time point, three were significantly better able to locate a target with the system switched on than with it off, as measured by square localisation. This is a method of assessing blindness severity in which subjects must touch a white square on a black computer screen.
Two of the five patients were significantly better able to determine the direction of motion of a target with Orion on than with it off. This harder test involves subjects watching a white bar move across the screen in different directions and drawing its movements on the screen.
All five subjects were rated by mobility specialists as having received positive or mildly positive benefit from Orion in terms of functional vision and wellbeing.
All of this is vaguely encouraging for such an early project. The feasibility trial is intended to reassess patients periodically out to five years, and it would be reasonable to expect Orion's performance to improve.
The real worry is the serious device or procedure-related adverse event, a seizure, seen in one patient. Four non-serious adverse events have also occurred.
The other cloud on the horizon is Second Sight’s main rival, Pixium Vision. Pixium’s Iris II epiretinal implant, which works similarly to Second Sight’s Argus II, is CE marked, but was subsequently found not to last as long as the company had hoped. Implants of this device have ceased.
Instead Pixium is focusing on another system, Prima, a wireless sub-retinal implant for patients with dry age-related macular degeneration. This is scheduled to enter a US feasibility study by summer, and an EU pivotal study soon afterwards.
Second Sight can comfort itself with the thought that Prima is still a single-indication product and would have a more limited patient pool than Orion. But a look at the consensus sales forecasts compiled by EvaluateMedTech shows that the sellside ultimately sees Pixium coming out the winner, with 2024 sales of $156m versus Second Sight’s $134m.
|Second Sight vs Pixium Vision|
|Annual sales ($m)|
|Second Sight Medical Products||8||13||23||35||54||86||134||+61%*|
|*CAGR 2018-24; **CAGR 2022-24. Source: EvaluateMedTech.|