BASEL, Switzerland, October 16, 2026
Roche (SIX: RO, ROP; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng® (satralizumab) for adults with thyroid eye disease (TED), introducing the first and only at-home subcutaneous treatment option for the condition, according to the company. The therapy can be administered by patients or caregivers after training from a healthcare professional, with dosing every four weeks during the maintenance phase. The approval was supported by data from the Phase III SatraGO-1 and SatraGO-2 studies, which evaluated the efficacy, durability and tolerability of Enspryng in adults with active, moderate-to-severe or chronic TED. Although SatraGO-1 did not meet its prespecified primary efficacy endpoint at Week 24, SatraGO-2 demonstrated significant improvements in eye bulging, known as proptosis, and double vision, or diplopia, among patients with active TED. In SatraGO-2, 52.9% of patients receiving Enspryng achieved a proptosis response, compared with 23.4% receiving placebo, while diplopia reduction was reported in 60.7% and 25.8% of patients, respectively. Roche reported no new safety signals across the trials. The approval expands Enspryng’s use beyond neuromyelitis optica spectrum disorder (NMOSD), for which it was approved in 2020.
Phase III Results Support FDA Approval
The SatraGO clinical programme comprised two identically designed, randomized, placebo-controlled, multicenter Phase III studies: SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828). Together, the studies enrolled 258 patients across 19 countries. Participants were randomized in a 1:1 ratio to receive Enspryng or placebo. The primary endpoint was the proportion of participants with active, moderate-to-severe TED who achieved a reduction of at least 2 mm in proptosis in the study eye from baseline at Week 24. While SatraGO-1 did not meet its prespecified primary efficacy endpoint, SatraGO-2 demonstrated statistically significant and clinically meaningful differences in proptosis response and diplopia reduction in the active TED population. Consistent results were also reported in the overall SatraGO-2 population, which included patients with active and chronic disease. The findings were previously presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery Fall Scientific Symposium in October 2025. Roche stated that the safety profile observed across both studies was consistent with Enspryng’s established profile in NMOSD, with no new safety signals identified. The company said the totality of the clinical data supported the new indication.
At-Home Subcutaneous Administration Expands Treatment Options
Enspryng is a humanized monoclonal antibody developed by Chugai Pharmaceutical, a member of the Roche Group. It binds to both soluble and membrane-bound interleukin-6 receptors (IL-6R), inhibiting IL-6-mediated signaling, a pathway involved in inflammation. The therapy uses Chugai’s proprietary antibody-recycling technology, designed to support repeated target engagement and sustained inhibition of IL-6 signaling. Roche said the at-home subcutaneous option provides flexibility for patients and healthcare professionals, potentially reducing the logistical demands associated with infusion-based treatment. Under the approved approach, patients or caregivers may administer the medicine after receiving appropriate training from a healthcare provider. Roche Chief Medical Officer and Head of Global Product Development Dr. Levi Garraway described the approval as an additional treatment option for people with TED, while clinical investigator Dr. César A. Briceño of the University of Pennsylvania’s Scheie Eye Institute highlighted the potential practical benefits of subcutaneous administration. The availability of this route offers an additional way to manage treatment, although individual treatment decisions will depend on clinical circumstances and prescribing guidance.
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Roche Expands Enspryng’s Autoimmune Disease Programme
Thyroid eye disease, also known as Graves’ ophthalmopathy, is an inflammatory autoimmune condition affecting tissues around the eyes and the eyes themselves. Symptoms can include redness, swelling, eyelid retraction, proptosis, double vision and pain. In severe cases, the disease can cause vision-threatening complications and lasting changes in appearance. Roche estimates that TED affects approximately 155 people per 100,000 in the United States. The condition is frequently associated with hyperthyroidism but can also occur in people with hypothyroidism or normal thyroid function. The new indication represents Enspryng’s second approved use, following its 2020 approval for NMOSD. Roche is also developing the therapy for additional neurological autoimmune and inflammatory diseases. In September 2026, the FDA granted priority review to a supplemental Biologics License Application for Enspryng in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), with a decision expected in January 2027. Other investigational areas include autoimmune encephalitis. Roche continues to develop medicines across ophthalmology, neurology, immunology and other therapeutic areas. The TED approval adds another indication to its portfolio and provides an at-home subcutaneous treatment option for eligible adults with the condition.
Source::: Roche,press release
