Second Sight's Argus II Retinal Prosthesis System selected for Forfait Innovation reimbursement

The Argus(R) II ‘bionic eye’ restores some functional vision to blind patients living with the rare disease retinitis pigmentosa

Second Sight Medical Products Inc. (Second Sight) announces today that the Argus II Retinal Prosthesis System, the world’s first approved device intended to restore some functional vision for people suffering from blindness due to outer retinal degenerations, has become the first recipient of the French Government national healthcare reimbursement program entitled ‘Forfait Innovation’.

The French Minister of Social Affairs and Health, Marisol Touraine, and her cabinet selected the Argus II for the ‘Forfait Innovation’ Award, a new funding mechanism launched by the Ministry of Social Affairs and Health to fast track the provision of innovative healthcare technologies to French patients. Argus II represents the first ever medical device to benefit from dedicated support through this program. 

The Forfait Innovation funding covers the costs of implantation of Argus II and includes patients’ hospital fees. With funding for this innovative technology now in place, a long-awaited official program to treat advanced retinitis pigmentosa (RP) is commencing in France. Up to 30 RP patients per year in France now stand to benefit from this life-changing technology. 

Significantly, the FDA-approved and CE-marked Argus II is the first medical device to receive funding through the ‘Forfait Innovation’ in the five years since the funding was announced. 

Marisol Touraine has confirmed that the 'Forfait Innovation' means that French patients with advanced RP will gain ‘early access’ to the innovative Argus II treatment.

Professor Jose-Alain Sahel, professor of Ophtalmology, University Pierre et Marie Curie, head of department, Quinze-Vingts Hospital, director of the Vision Institute (UPMC/INSERM/CNRS), said of this decision: “We have been involved in the development of this product for more than five years. This announcement is hugely significant for us and for French patients blinded by retinal diseases. These patients face a great unmet medical need, as there are no current solutions to improve their vision. Additionally, the announcement provides encouragement for other solutions currently under development at Vision Institute in Paris, to further ameliorate conditions resulting in blindness.”

Gregoire Cosendai, Second Sight’s vice president, Europe, said: “We salute the decision of Marisol Touraine, Minister of Social Affairs and Health following a thorough health technology assessment conducted by the team at the Haute Autorite de Sante who determined that this innovative solution for restoring vision was worthy of reimbursement in France. It is tremendous news for several patients in France who have been blind for some time and are awaiting a treatment to improve their vision and quality of life. It’s also a great tribute to the excellence of the Quinze-Vingts Hospital who participated in the multicenter clinical trial that lead to the first market approval of the Argus II retinal prosthesis in Europe and the USA.”

With this decision, France joins a number of other countries in Europe that fund the Argus II device, while in the UK, the National Health Service is currently considering reimbursement for the device. After commercial launch in Europe in 2011, Second Sight announced in January of this year (2014) that the first US patients have been implanted following FDA approval last year (2013).

The Argus II System works by converting video images captured by a miniature camera housed in the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns, thereby regaining some visual function. 

According to a study published in the British Journal of Ophthalmology (BJO)[1] the majority of blind subjects fitted with the Argus II consistently identify letters and words using the retinal implant, indicating reproducible spatial resolution. This, in combination with the proven, stable, long-term function of the device, represents significant progress in the evolution of artificial sight.