Science Corporation Announces Clinical Trial Update: First Patient With Stargardt Disease Using PRIMA

PRIMA, a wireless brain-computer interface implant, is now commercially available in Europe for patients with vision loss caused by geographic atrophy. In a New England Journal of Medicine study, 84% of 32 patients assessed at 12 months reported being able to read letters, numbers, and words.

The technology is now being trialled for Stargardt disease and retinitis pigmentosa. In the PRIMAlia trial at Sydney Eye Hospital, the first Stargardt patient received the implant in May and read a word during his second rehabilitation session.

The FDA granted PRIMA Humanitarian Use Device designations for advanced geographic atrophy and Stargardt disease. The device must still receive Humanitarian Device Exemption approval before treating patients outside clinical trials in the U.S.

How PRIMA Works.

The PRIMA implant sits beneath the retina, where photoreceptors have degenerated. Photovoltaic pixels convert infrared light from PRIMA glasses into electrical signals, stimulating remaining retinal cells to transmit visual information to the brain.

PRIMA is CE-marked in the EU and registered for supply in the UK but has not received FDA approval. In Australia, it remains an investigational device undergoing clinical trials and is not available commercially.