FDA Approves Enspryng for Thyroid Eye Disease, the First At-Home Subcutaneous Treatment
The U.S. Food and Drug Administration (FDA) has approved Genentech's Enspryng (satralizumab-mwge) for the treatment of adults with thyroid eye disease (TED), the company announced on October 15 at its South San Francisco headquarters. Genentech, a member of the Roche Group, said Enspryng is the first and only at-home subcutaneous treatment option for the disease, and can be administered by the patient or a caregiver after training from a healthcare provider.
Thyroid eye disease, also known as Graves' ophthalmopathy, is an autoimmune inflammatory disorder of the eye and surrounding tissues. Common symptoms include bulging eyes (proptosis), double vision, eyelid retraction, redness, swelling and pain, and the disease can threaten vision. Genentech said TED affects approximately 155 out of every 100,000 people in the United States and occurs most commonly in people with hyperthyroidism.
The approval, granted following a priority review, was based on two Phase III studies, SatraGO-1 and SatraGO-2, which enrolled a total of 258 patients from 19 countries. In SatraGO-2, 52.9% of patients with active TED receiving Enspryng achieved the proptosis response endpoint at week 24, compared with 23.4% on placebo, and 60.7% achieved a reduction in double vision, compared with 25.8% on placebo. No new safety signals were identified. Genentech noted that SatraGO-1 did not meet its pre-specified primary efficacy endpoint, and that the approval rested on the totality of the data.
This is the second U.S. indication for Enspryng, following its 2020 approval for neuromyelitis optica spectrum disorder (NMOSD). Dr. César A. Briceño, a clinical trial investigator and associate professor of ophthalmology at the Scheie Eye Institute of the University of Pennsylvania, said a subcutaneous option could offer greater flexibility for patients and physicians while reducing the logistical burden of infusion-based therapies. Dr. Levi Garraway, Genentech's chief medical officer, said the approval provides an important new option for people with TED, who have long faced limited treatment choices.
Source: GSM · USA (original Chinese edition)
Photo: 甲状腺眼病（格雷夫斯眼病）患者眼球突出与眼睑退缩临床照片（资料图）。照片：Jonathan Trobe 医学博士／密歇根大学 Kellogg 眼科中心，CC BY 3.0，经 Wikimedia Commons
- 2026-10-16FDA Approves Enspryng for Thyroid Eye Disease, the First At-Home Subcutaneous TreatmentThis story
- 2026-10-17FDA Approves Enspryng for Thyroid Eye Disease, the First At-Home Subcutaneous Treatment for the Condition
