Argus II retinal prosthesis system shows continued safety, efficacy 5 years after implantation

Issue: September 10, 2016

The Argus II retinal prosthesis system restored some basic visual function at 5 years after implantation in patients who were blind from retinitis pigmentosa or outer retinal degeneration, according to a study.

Perspective from Andrew P. Schachat, MD

The prospective, multicenter, single-arm clinical trial included 30 patients who were blind from retinitis pigmentosa or outer retinal degeneration and who were implanted with the Argus II (Second Sight Medical Products). Patients were treated at 10 centers throughout the U.S. and Europe.

The primary endpoints of the study were safety, which included the rate, type and severity of adverse events, and visual function, which was measured by three computer-based objective tests.

No eyes were enucleated during the study, and serious adverse events were treatable with standard ophthalmic approaches.

At 5 years, 24 patients still had a functioning device implanted. All patients showed significantly better results in visual function tests and functional vision tasks, a secondary endpoint, when the device was turned on instead of off.

Researchers assessed patients’ visual function by looking at square localization, direction of motion and grating visual acuity. With the Argus II turned on, 80.9% of patients performed better on square localization, 50% of patients performed better on direction of motion, and 38.1% of patients performed better on grating visual acuity.

The study patients will be followed out to 10 years for very long-term safety and efficacy data.

“These new long-term data from the original study continue to demonstrate that this therapy remains an option for patients with [retinitis pigmentosa] and may allow for stable and reliable restoration of some basic visual function,” the study authors said. – by Nhu Te

Disclosure: da Cruz reports he is a consultant for Second Sight Medical Products. See the full study for all other authors’ relevant financial disclosures.

Perspective

Andrew P. Schachat, MD

Those of us who grew up with Star Trek of course anticipated the development of the Argus implant, but it is sure nice to see it come to fruition. The authors report that 24 of 30 subjects maintained a functioning implant at 5 years with only one new serious adverse event since the year 3 report. For carefully selected subjects who have access to the sophisticated low vision services needed to help patients use the device, the implant offers exciting benefits. An important next step will be for the manufacturers to scale up and/or automate the production process to allow lower cost. While I can justify $150,000 to help a completely blind patient have partial vision, it would be spectacular if this could be accomplished at a much lower cost. Cost or not, Mr. Obama was impressed. So am I.

Andrew P. Schachat, MD

Vice chairman for clinical affairs, Cole Eye Institute

Disclosures: Schachat reports he is a full-time employee of the Cleveland Clinic and part-time employee of the state of Ohio. He receives royalties from the American Academy of Ophthalmology and Elsevier. He may receive future income, none to date, from Easton Capital.

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Sources/Disclosures

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Source:

da Cruz L, et al. Ophthalmology. 2016;doi:10.1016/j.ophtha.2016.06.049