PARIS – Pixium Vision SA is preparing to launch a European multicenter trial for Prima, its miniature wireless subretinal photovoltaic implant, for patients who have lost their sight as a result of dry age-related macular degeneration (AMD).
This pivotal trial will recruit 50 patients from 10 major eye hospitals in France, the U.K., Germany, Italy and Spain. "Our Prima device, [which restores] visual function to the area of the macula with no residual sight, opens up valuable prospective treatment for patients with dry AMD," Khalid Ishaque, CEO of Paris-based Pixium Vision, told BioWorld MedTech.
AMD is the primary cause of severe sight loss in people 65 years of age and older in both Europe and the U.S. According to a systematic review and meta-analysis in Lancet Global Health, it affects 196 million people globally. This figure continues to rise due to an aging population. According to Ishaque, "more than 5 million people are affected by the dry form of the condition, which causes geographic atrophy at the center of the retina. There is currently no treatment for this most common form of AMD."
Pixium Vision was formed in 2011 by Bernard Gilly on the back of a commercial partnership between a group of scientists from various research institutes. The med-tech firm has devoted more than five years of preclinical research into developing the system invented by French and American eye specialists. Pixium Vision also has invested $84 million in R&D.
Prima: a machine-brain interface
The Prima system includes a wireless subretinal implant, a pair of glasses fitted with a camera, a projector and a pocket computer. The photovoltaic retina implant measures 2 millimeters by 2 millimeters and is 30 micrometers thick. This microchip holds 378 electrodes. Implanted directly under the retina where the photoreceptors have degenerated, it converts a near-infrared signal from a digital projector weighing 200 grams, mounted on a pair of glasses fitted with a minicamera, into an electrical signal transmitted to the brain via the optic nerve.
Between 2015 and 2017, the company tested its Prima implant on rats, pigs, cats and apes. Last year, Pixium Vision started human feasibility trials. The French trial, conducted on five patients with dry AMD and visual acuity of 20/400 or worse and no foveal vision, assessed the safety, tolerance and visual perception from electrical stimulation of the Prima implant. It took place at the Rothschild Foundation Hospital in Paris.
This early feasibility trial has shown that the implant, placed during surgery that lasts less than two hours, is well tolerated without any serious adverse incidents. It also preserves a patient's residual peripheral visual acuity and restores the lost part of central vision. All patients can see light at the center of their field of vision. Their visual acuity is improving, allowing them to identify patterns, objects and complex signals, such as letters and sequences of letters.
A similar feasibility trial involving five patients is underway in the U.S. at the University of Pittsburgh Medical Center. According to Ishaque, "The next European multicenter pivotal trial will enable us to plan for CE-marking approval in 2022, and premarket notification for the U.S. two years later."
The company, which employs 30, does have competition. For example, Second Sight Medical Products Inc., of Los Angeles, supplies the Argus II implant for retinitis pigmentosa. Bionic Vision Technologies Pty. Ltd., of Victoria, Australia, carried out a clinical trial of three patients with retinitis pigmentosa as a proof of concept for its retinal implant with 24 electrodes, but no camera was connected to the device. Finally, Nano Retina, of Herzliya, Israel, is in the early stages of development for its ultra-compact artificial retina NR600, indicated for retinitis pigmentosa. "Pixum Vision is the sole med tech developing a wireless implant placed into patients with dry AMD," said Ishaque.
The now-shuttered Retina Implant AG, of Reutlingen, Germany, was developing the Alpha AMS implant; however, it ceased trading March 19.
A further funding round this year for $22M
Pixium Vision counts among its past shareholders three French investment funds – Bpifrance, Omnes Capital SAS and Seventure Partners – and a British investment firm, Abingworth LLP. The three investment funds together hold 51.6% of Pixium Vision's capital. The company is valued at $39 million on Euronext Paris and currently has $18 million in cash reserves. This will just about fund development of its technology and clinical trials for the current year. "That is why I am going to launch a $22 million funding round this year, to finance a pivotal European clinical trial and to get ready to commercialize the Prima platform," said Ishaque.