FDA approves Roche’s Enspryng as First at-Home Injection for TED

Rare Daily Staff

The U.S. Food and Drug Administration approved Roche’s Enspryng for adults with thyroid eye disease, making it the first treatment for the condition that patients or caregivers can inject under the skin at home after training.

The approval offers a new option for people with a potentially sight-threatening disease, although one of the drug’s two pivotal studies failed to meet its main efficacy goal.

The FDA reviewed the application under its priority review process. Thyroid eye disease is Enspryng’s second approved indication in the United States, following its 2020 approval for neuromyelitis optica spectrum disorder.

Thyroid eye disease is a rare autoimmune condition in which the immune system causes inflammation in and around the eyes. It can cause eye bulging, double vision, pain, redness, swelling and eyelids that pull back, giving the appearance of a stare. Severe cases can threaten sight and alter a person’s appearance. The disease most often occurs in people with an overactive thyroid but can also develop in those with an underactive thyroid or normal thyroid function.

Enspryng is a monoclonal antibody that blocks receptors for interleukin-6, a protein involved in inflammation. Developed by Roche Group member Chugai, the drug uses antibody-recycling technology designed to keep it circulating longer and sustain its effects. Patients receive an injection under the skin every four weeks during the maintenance phase of treatment.

The approval was supported by two identically designed phase 3 studies, SatraGO-1 and SatraGO-2, which enrolled a combined 258 adults across 19 countries. Participants had either active, moderate-to-severe thyroid eye disease or chronic disease and were randomly assigned to receive Enspryng or a placebo. The main measure of effectiveness was the proportion of patients with active disease who achieved at least a 2-millimeter reduction in eye bulging in the study eye at 24 weeks.

SatraGO-1 did not meet its prespecified primary efficacy endpoint. In SatraGO-2, however, 52.9 percent of patients with active disease who received Enspryng achieved the eye-bulging response, compared with 23.4 percent of those given placebo. Double vision improved in 60.7 percent of patients receiving Enspryng, compared with 25.8 percent receiving placebo. Roche said SatraGO-2 also showed consistent results in the broader study population, which included patients with chronic disease.

Roche reported no new safety signals in the studies and said the drug’s safety profile was consistent with its established profile in neuromyelitis optica spectrum disorder, another autoimmune disease for which Enspryng is approved. The company presented the full thyroid eye disease study results at a scientific meeting in October 2025.

“The availability of an effective subcutaneous treatment option could provide greater flexibility for both patients and physicians while reducing the logistical burden associated with infusion-based therapies,” said César Briceño, a study investigator and associate professor of ophthalmology at the University of Pennsylvania’s Scheie Eye Institute.