FDA approves Enspryng as first at-home shot for thyroid eye disease
The FDA approved Enspryng as the first at-home shot for adults with thyroid eye disease, according to Ophthalmology Times. Patients get a shot every two weeks for three doses, then once every four weeks. In one of two trials, about 53% saw less eye bulging, versus 23% on a placebo.
The Food and Drug Administration has approved Enspryng, from Roche's Genentech, to treat adults with thyroid eye disease, according to Ophthalmology Times and the company's announcement. It is the first treatment for the condition that patients can inject under the skin at home.
Thyroid eye disease is a rare immune condition that inflames the tissue around the eyes, WebMD reported. It can cause swelling, pain, double vision and bulging eyes. Enspryng, known generically as satralizumab, blocks a protein called interleukin-6 that drives the swelling. It is the first drug of its kind approved for the disease, Ophthalmology Times reported.
Patients or caregivers can give the shot in the belly or thigh after training, WebMD reported. The first three doses come every two weeks, then one dose every four weeks.
The approval was based on two trials, SatraGO-1 and SatraGO-2, with 258 patients from 19 countries, Ophthalmology Times reported. The results were mixed. SatraGO-2 met its main goal: 52.9% of patients on Enspryng had a meaningful drop in eye bulging at 24 weeks, compared with 23.4% on a placebo. About 61% saw their double vision improve, compared with 26% on placebo, WebMD reported. SatraGO-1 did not meet its main goal at 24 weeks, but the studies taken together showed meaningful benefits, according to WebMD.
The most common side effects were upper respiratory infections and higher liver enzymes, and no serious infections were reported in the Enspryng group, WebMD reported.
"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, Ophthalmology Times reported.
The FDA gave Genentech's supplemental application priority review, with an Oct. 15 target date, Ophthalmology Times reported. Neither outlet reported its price.
What we know: Enspryng is now approved as an at-home shot for adults with thyroid eye disease.
What we don't: What the treatment will cost and how insurers will cover it. Only Ophthalmology Times has reported this independently so far; NewsHabit hasn't seen independent confirmation.
Where outlets agree Genentech's approval announcement and Ophthalmology Times both state that the FDA approved Enspryng as the first at-home shot for thyroid eye disease, based on two trials with 258 patients.
Where they differ Ophthalmology Times reports the approval as Roche describes it, and no one cited here disputes it, though one of the two trials missed its main goal.