UPFRONT

Making It So

Peter K. Kaiser, MD

The 2013 Invention of the Year in Popular Science and the Cleveland Clinic’s Innovation of the Year in 2014 was the Argus II retinal prosthesis system (Second Sight Medical Products, Sylmar, CA). Mark Humayun, MD, and his team of engineers developed this biomedical engineering tour de force over the past quarter century with more than $100 million in funding. This incredible technological achievement essentially restores roughly 60-pixel vision to blind patients. It’s not ultra-HD, but for the patients who need it, it’s life changing

Argus II is the first FDA-approved “bionic eye,” and I am sure many of your patients with age-related macular degeneration are asking you daily about getting one. However, it is only approved for patients with advanced retinitis pigmentosa with bare light perception vision or worse (hand motions or worse in the EU).

My patients’ eyes usually gloss over when I explain to them that it is approved as a humanitarian-use device (HUD) only in this orphan indication. A HUD requires the company to provide evidence to the FDA, showing that the probable benefits of Argus II outweigh its risks and that no comparable device is available. It does not require any proof of efficacy.

The inevitable next question is why can’t they get an Argus II to restore their vision loss due to AMD and where can they make out their check. If only it were so easy. An AMD approval would require a significantly larger trial(s) than the very small, international trial required for a HUD. Now, one could attempt to obtain an orphan-subset indication that may work in patients with severe AMD, but proving and defining such an indication would be incredibly difficult.

The other important consideration concerns improvements in the technology that inevitably occur. My patients don’t understand that the upgrade cycle for the device is not like our trusty mobile phones, with which better cameras are expected every year with higher resolutions and features.

Undoubtedly, there are better versions of the Argus being tested in Dr. Humayun’s lab. But it’s not as simple as upgrading the camera or videoprocessing unit in patients who already have the device because this would require a whole new FDA approval process. Moreover, who would pay for the upgrade? Insurance? The patient?

In this issue, we explore the long-term results of patients implanted with the Argus II in clinical practice. The device is being placed in increasing numbers of patients, with 15 patients being implanted in the last quarter of 2014, the most of any quarter.

It is important to remember that the Argus II is not the only “bionic eye.” Numerous other companies throughout the world are exploring visual prostheses. It is an exciting time in retina. In 2339, when young Geordi, who was born blind, receives his first visor, it might have started with this.