Science Corp 的 PRIMA 获 FDA 两项人道主义使用器械认定
PRIMA Has Received Humanitarian Use Device Designations from the US Food and Drug Administration
Science Corp 宣布其 PRIMA 获得 FDA 两项人道主义使用器械（HUD）认定，分别针对晚期地图样萎缩（GA）继发于年龄相关性黄斑变性（AMD）导致的双目失明患者，以及因 Stargardt 病丧失视力的患者。
PRIMA 同时拿到两项 HUD 认定，原文交代了适用人群和后续仍需 HDE 审批的路径，可看清其在美国的上市节奏。
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.
来源：Science Corp · science.xyz