• FDA approval based on Phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating a significant reduction in eye bulging (proptosis) and improvement in diplopia (double vision), with a favourable safety profile, regardless of TED activity or duration^1,2  
• Enspryng (satralizumab) represents an important advance for people with TED, offering the first at-home SC treatment option every four weeks during maintenance phase, allowing for greater flexibility in how treatment is administered¹
• Enspryng is an anti-IL-6R mAb using novel recycling antibody technology designed to inhibit IL-6 signalling upstream of autoantibody-driven pathology^2,3
• TED is a rare autoimmune disease affecting approximately 155 out of every 100,000 people in the US that can lead to facial disfigurement and vision-threatening complications if left untreated^3-7

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng® (satralizumab) for the treatment of adults with thyroid eye disease (TED), providing patients with the first and only at-home subcutaneous treatment option. Enspryng can be administered by a person living with TED or a caregiver following training from a healthcare provider.¹

“Today’s FDA approval of Enspryng provides an important new option for people with thyroid eye disease, who have long faced limited treatment choices,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “As the first subcutaneous treatment for this condition, Enspryng offers a positive safety and efficacy profile and the potential for at-home administration.”

"Treating thyroid eye disease requires balancing efficacy, safety, and the practical realities of long-term treatment,” said César A. Briceño, MD, Clinical Trial Investigator and Associate Professor of Ophthalmology at the Scheie Eye Institute, University of Pennsylvania. “As a clinical trial investigator, I have seen firsthand the potential of targeted therapies such as Enspryng. 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. Enspryng has the potential to meaningfully expand our therapeutic options for patients with thyroid eye disease."

The totality of data from the pivotal Phase III SatraGO programme (SatraGO-1 and SatraGO-2) provided clinically meaningful improvements in patients with TED.^1,2 While SatraGO-1 did not meet its pre-specified primary efficacy endpoint at Week 24, SatraGO-2 achieved significant and clinically meaningful difference in proptosis response (52.9% in the Enspryng group compared to 23.4% in the placebo group) and in diplopia reduction (60.7% in the Enspryng group compared to 25.8% in the placebo group) in the active TED population.^1,2 Consistent results were achieved in the overall population (including both active and chronic patients) in SatraGO-2.^1,2 No new safety signals were identified in the SatraGO trials, with Enspryng’s safety profile consistent with its known profile in neuromyelitis optica spectrum disorder (NMOSD).^1,2 Full results were shared at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium in October 2025.²

“Thyroid eye disease not only affects a person’s eyes through bulging and vision problems, but it also takes a profound emotional toll on confidence, identity, relationships and daily life,” said Christine Gustafson, Chief Executive Officer of the TED Community Organization. “Until now, our community has had very limited choices. The approval of Enspryng represents a critical turning point through a convenient, targeted option.”

The approval in TED, following a priority review designation, marks the second indication for Enspryng, following an approval in neuromyelitis optica spectrum disorder (NMOSD) in 2020.^1,8,9 This follows a recent acceptance by the FDA for priority review in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).¹⁰ Enspryng is also being studied in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling.