Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

Area of Science:

• Ophthalmology
• Biomedical Engineering
• Neuroscience

Background:

• Retinitis pigmentosa (RP) causes progressive vision loss, leading to blindness in many individuals.
• Current treatments for end-stage RP are limited, creating a need for innovative solutions.
• The Argus II Retinal Prosthesis System was developed to provide artificial vision for RP patients.

Purpose of the Study:

• To evaluate the long-term safety and efficacy of the Argus II Retinal Prosthesis System.
• To assess visual function and functional vision performance in patients with RP.
• To determine the durability and benefit of the Argus II System over a 5-year period.

Main Methods:

• A prospective, multicenter, single-arm clinical trial involving 30 participants with end-stage RP.
• Implantation of the Argus II System in the worse-seeing eye.
• Comparison of visual function with and without the Argus II System, using objective tests and real-world tasks.

Main Results:

• Twenty-four out of 30 patients maintained a functioning Argus II implant at 5 years.
• A low rate of serious adverse events was observed, with only one additional event after 3 years.
• Patients demonstrated statistically significant improvements in visual function and real-world task performance with the Argus II activated.

Conclusions:

• The Argus II Retinal Prosthesis System demonstrates a favorable long-term safety profile and provides significant benefits for patients with RP-related blindness.
• The Argus II System is the first and only retinal implant approved in major markets including the EEA, US, and Canada.
• These findings support the Argus II as a viable option for vision restoration in individuals with severe retinal degeneration.