Second Sight Expands Treatment Reach in Europe

Second Sight Medical Products Inc. is expanding the reach of its Argus II Retinal Prosthesis System in Europe. The Sylmar, Calif.-based firm reported that the first commercial implants of the system have been performed in Austria and Turkey, and in Spain through a distribution agreement with IMEX, the largest distributor of ophthalmic products in Spain.

In Vienna, Austria, the device was implanted in a 54-year-old patient who was previously completely blind for over 25 years from retinitis pigmentosa (RP). In Austria, there are an estimated 3,100 people living with RP. In Turkey, the Argus II was implanted in a 44-year-old patient. It is estimated that of Turkey’s 76 million people, approximately 28,000 people are living with RP.

“We are pleased to see the expanded availability of the Argus II in Austria and Turkey and look forward to the next steps of working with the respective governments on national reimbursement,” said Robert Greenberg, M.D., CEO of Second Sight. “The availability of the Argus II in these additional countries will provide patients with RP the chance to lead more independent lives, which can be life changing for these individuals.”

The recent implant in Spain, under a distribution agreement with IMEX, was performed at the Arruzafa Clinic in Cordoba, Spain. To accommodate demand for the Argus II, IMEX plans to increase staffing and provide dedicated clinical support.

“Our exclusive distribution agreement with IMEX allows us to provide access to the Argus II to the estimated 17,000 individuals in Spain with RP. We look forward to leveraging IMEX’s unmatched reach within the ophthalmology communities on the Iberian Peninsula to reach individuals with outer retinal degeneration,” said Greenberg.

RP is an inherited disease that causes degeneration of the photoreceptor cells, which are critical for discerning visual stimuli. Patients with RP initially experience a loss of peripheral vision and the ability to see in dimly lit situations. Over time, vision becomes increasingly impaired, leading to an experience of “tunnel vision” before progressing to complete blindness in most cases.

The Argus II implant system, the first approved retinal implant in the world, has been implanted in more than 130 individuals worldwide. The system induces visual perception in blind individuals by providing electrical pulses to stimulate the retina’s remaining cells, which is intended to result in a perception of light patterns in the brain. The Argus II has the potential to offer life-changing visual capabilities to those with little or no remaining functional vision. The Argus II implant can positively impact a blind person’s ability to conduct routine daily activities, such as recognizing shapes or large objects, locating people, identifying the location of doorways, and following lines or edges. Ultimately, this is meant to allow Argus II users to live their daily lives with more confidence.

The Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound retinitis pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells, resulting in the perception of patterns of light in the brain. The patient then learns to interpret these visual patterns, thereby regaining some visual function. The Argus II is the first artificial retina to receive widespread approval, and is offered at approved centers in Austria, Canada, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland, Turkey, United Kingdom and the United States.

Enrollment is underway in a trial to test the safety and utility of the Argus II in individuals with dry age-related macular degeneration. Second Sight is also developing the Orion I Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than preventable or treatable conditions.