FDA grants PRIMA Humanitarian Use Device designations for advanced geographic atrophy and Stargardt disease

Science Corporation/PRIMA retinal implant

The FDA granted Science Corporation's PRIMA retinal implant two Humanitarian Use Device designations: one for blind patients with advanced geographic atrophy, recognised as a rare subset of age-related macular degeneration, and one for Stargardt disease, an inherited retinal disease. The designations open a faster US route to market for rare conditions. PRIMA still needs FDA approval through a Humanitarian Device Exemption before it can be sold in the US.

• A Humanitarian Device Exemption requires proof of safety and probable benefit rather than full efficacy trials, and it is meant for small patient populations.
• Both conditions destroy central vision irreversibly and have no approved treatment that restores it.
• The evidence base: nearly 50 patients across four clinical trials over two decades of development.