Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), announced on Friday that it has received US Food and Drug Administration (FDA) approval for Enspryng (satralizumab-mwge) to treat adults with thyroid eye disease (TED), introducing the first and only at-home subcutaneous treatment option for the condition.

The approval was supported by Phase III SatraGO-1 and SatraGO-2 trials. While SatraGO-1 did not meet its prespecified primary efficacy endpoint at week 24, SatraGO-2 showed improvements in proptosis response, reported in 52.9% of patients receiving Enspryng versus 23.4% on placebo, and diplopia reduction, at 60.7% versus 25.8%, among patients with active TED.

No new safety signals were identified, and Enspryng's safety profile was consistent with its established profile in neuromyelitis optica spectrum disorder (NMOSD).

The treatment can be administered by patients or caregivers following healthcare provider training, with maintenance dosing every four weeks.

This approval marks Enspryng's second indication, following its 2020 approval for neuromyelitis optica spectrum disorder (NMOSD), and comes after the FDA granted priority review for the TED application. The agency has also accepted Enspryng for priority review in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).

TED is a rare autoimmune disease affecting approximately 155 people per 100,000 in the United States. It can cause eye bulging, double vision, disfigurement and vision-threatening complications.