Mind-Machine

FDA grants PRIMA two Humanitarian Use Device designations, covering advanced geographic atrophy and Stargardt disease

Science Corporation disclosed on 22 July 2026 that its PRIMA implant has received two Humanitarian Use Device (HUD) designations from the US Food and Drug Administration. The first covers patients blinded by advanced geographic atrophy secondary to age-related macular degeneration; because geographic atrophy itself is not a rare disease, the FDA approved the advanced bilateral-blindness form as an 'orphan subset' of the broader condition. The second covers patients who have lost vision to Stargardt disease, a rare inherited retinal disease. The company notes the HUD programme offers expedited review, but that a device must still be reviewed and approved by the FDA via a Humanitarian Device Exemption before it can be marketed - so this establishes a regulatory path rather than authorising US sales. The disclosure states that over two decades of research and clinical work, including nearly 50 patients across four clinical trials worldwide, led to the designations. The post is authored by Frank Brodie, Medical Director for Vision and PRIMA at Science. PRIMA had previously received FDA Breakthrough Device designation.