Roche has secured US FDA approval for Enspryng (satralizumab) to treat adults with thyroid eye disease (TED), introducing the first and only at-home subcutaneous treatment option for the condition.
The treatment can be self-administered by people living with TED or given by a caregiver after training from a healthcare provider, potentially reducing the need for hospital or clinic visits for infusion-based therapies.
“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, 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.”
The approval was supported by data from Roche’s pivotal Phase III SatraGO programme, comprising the SatraGO-1 and SatraGO-2 trials. While SatraGO-1 failed to meet its pre-specified primary efficacy endpoint at Week 24, SatraGO-2 demonstrated significant and clinically meaningful improvements in eye bulging and double vision among patients with active TED.
In SatraGO-2, 52.9% of patients receiving Enspryng achieved a proptosis response, compared with 23.4% in the placebo group. Reductions in double vision, or diplopia, were recorded in 60.7% of patients receiving Enspryng, against 25.8% of those given placebo.
Consistent results were also observed in the overall SatraGO-2 population, which included patients with both active and chronic disease.
No new safety signals were identified across the trials. Enspryng’s safety profile remained consistent with its established profile in neuromyelitis optica spectrum disorder (NMOSD), the condition for which it was first approved.
“Treating thyroid eye disease requires balancing efficacy, safety, and the practical realities of long-term treatment,” said César A. Briceño, 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."
Thyroid eye disease is an inflammatory condition that can cause the eyes to bulge, impair vision and disrupt everyday activities. Its effects can extend beyond physical symptoms, affecting patients’ confidence, relationships and quality of life.
“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.”
