FDA Approves Satralizumab as At-Home Subcutaneous Treatment for Thyroid Eye Disease
The US FDA has approved satralizumab (Enspryng), developed by Roche, as the first and only at-home subcutaneous treatment option for adults with thyroid eye disease (TED). The first-in-class humanized monoclonal antibody targets soluble and membrane-bound interleukin-6 (IL-6) receptors, inhibiting IL-6-mediated signaling, a key pathway involved in inflammation.
“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. Consistent results were achieved in the overall population (including both active and chronic patients) in SatraGO-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). Full results were shared at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium in October 2025.
“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). Enspryng is also being studied in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling.
