PRIMA received two Humanitarian Use Device (HUD) designations from the Food and Drug Administration. The HUD program offers expedited review for medical devices that treat patients with rare diseases or conditions. Once granted a HUD designation, a device must still be reviewed and approved by the FDA via a Humanitarian Device Exemption.
Our first HUD designation is for patients who have gone blind from advanced geographic atrophy (GA) secondary to age-related macular degeneration (AMD). While GA itself is not a rare disease, the very advanced form, leading to blindness in both eyes without vision loss from other eye diseases, is less common and was approved as an “orphan subset” of the more common disease—thereby allowing us to receive HUD designation and expedite market access to help these patients.
The second HUD designation is for patients who have lost vision from Stargardt disease, a rare inherited retinal disease.
Both conditions cause irreversible loss of central vision and have no approved treatment that restores it.
Over two decades of research and clinical work—including nearly 50 patients across four clinical trials worldwide—have led to these two HUD designations, establishing a clear regulatory path for PRIMA to reach patients in the US.
