Thyroid eye disease: US approves first treatment patients can inject at home
The US Food and Drug Administration has approved Roche's Enspryng for adults with thyroid eye disease. Patients can give themselves the injection under the skin every four weeks.
Archive image · Photo: Fred Romero from Paris, France / Wikimedia Commons, CC BY 2.0 (cropped and resized)
The US Food and Drug Administration (FDA) approved Roche's Enspryng (satralizumab) in October 2026 for adults with thyroid eye disease, also known as Graves' ophthalmopathy, the specialist site Pharmacally reported (16.10.2026). According to the report, it is the first treatment for the condition that can be given at home as an injection under the skin. Maintenance doses are given every four weeks by patients or carers after training by a healthcare provider.
Satralizumab is a monoclonal antibody that blocks the receptor for the inflammatory messenger IL-6. It has been approved since 2020 for the rare neurological disorder NMOSD. The new approval is based on two Phase III trials, SatraGO-1 and SatraGO-2, with a combined 258 participants in 19 countries.
The results were mixed. In SatraGO-2, eye bulging fell by at least 2 millimetres in 52.9 per cent of treated patients versus 23.4 per cent on placebo. In SatraGO-1 the difference (49.0 versus 31.2 per cent) was not statistically significant. No new safety signals were seen up to week 24. Roche estimates the condition affects about 155 people per 100,000 in the US. This is general information and no substitute for medical advice.
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