FDA approves Roche's Enspryng for thyroid eye disease after one of its two trials missed
In the trial that worked, 52.9% of patients with active disease saw eye bulging drop by 2 mm or more, against 23.4% on placebo. Its twin trial came in at 49.0% against 31.2% and fell short. Patients can inject it at home.
The Food and Drug Administration approved Enspryng (satralizumab) for adults with thyroid eye disease, Genentech said on Oct 15. Roche, Genentech’s parent, announced it the next day from Basel.
Patients or caregivers can give the shot at home after training. Roche calls it the first thyroid eye disease treatment given under the skin.
What thyroid eye disease is
Thyroid eye disease is an autoimmune disease that swells the tissue around the eyes. It causes bulging eyes, double vision, redness and pain, and it can threaten sight, Roche says.
It affects about 155 of every 100,000 people, per Roche. About half of people with an overactive thyroid get at least a mild form.
The label covers adults whether the disease is active or long standing, per the Enspryng prescribing information.
Two trials, one miss
FDA based the approval on SatraGO 1 and SatraGO 2, two phase 3 trials with the same design. They enrolled 258 patients in 19 countries, and 131 got Enspryng, per the label.
The main goal was the share of patients with active disease whose eye bulging dropped by 2 mm or more at week 24. In SatraGO 2, that was 52.9% on Enspryng against 23.4% on placebo, per the label.
SatraGO 1 missed. There, 49.0% responded on Enspryng against 31.2% on placebo, a gap that fell short of statistical significance (p = 0.07), the label shows.
What else SatraGO 2 showed
Across all patients in SatraGO 2, active and inactive, 46.9% responded against 22.2% on placebo, per the label.
Among patients with double vision at the start, 60.7% improved on Enspryng against 25.8% on placebo. Eye bulging fell by 1.97 mm on average, against 0.96 mm on placebo.
The trials excluded patients who had prior surgery or a biologic drug for the disease, the label says.
Dosing and safety
Patients up to 100 kilograms take 120 mg at weeks 0, 2 and 4, then every 4 weeks. Heavier patients take 180 mg on the same schedule, per the label.
Before the first dose, doctors must screen for hepatitis B, tuberculosis and liver enzyme levels. The label warns of serious infections, raised liver enzymes and low white blood cell counts.
In the trials, upper respiratory infections hit 5.3% of Enspryng patients against 2.4% on placebo. A rise in the liver enzyme ALT hit 5.3% against 0.8%, per the label.
Price and the competition
Genentech lists the 120 mg syringe at $18,905.57, per its price disclosure for Colorado prescribers dated July 1, 2026. The trials gave 7 doses through week 20, which comes to $132,339 at list price for a patient up to 100 kilograms, by our math. The 180 mg price is MISSING.
The main rival is Amgen’s Tepezza, which Amgen calls the first FDA approved treatment for the disease. Tepezza is given by IV infusion, per Amgen’s provider site.
Enspryng was first approved in 2020 for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the optic nerve and spinal cord. An FDA decision on a third use, MOGAD, is due in January 2027, Roche says.
Why it matters
Patients now have a shot they can take at home in place of IV infusions. Doctors weigh that against a trial record of one win and one miss.
FDA
