FDA grants Priority Review to Roche’s Enspryng, a potential first at-home subcutaneous treatment for thyroid eye disease

Roche has recently confirmed that the US Food and Drug Administration has accepted and granted Priority Review to a supplemental Biologics License Application for Enspryng for the treatment of thyroid eye disease. The acceptance rests on findings from two randomised, placebo-controlled global Phase III SatraGO studies evaluating the safety and efficacy of Enspryng in patients with moderate to severe thyroid eye disease, data from which were presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery in October 2025. A regulatory decision from the FDA is anticipated by 15 October 2026.

“The FDA’s decision to grant priority review to Enspryng is an important step toward expanding treatment options for people living with thyroid eye disease,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “By targeting the underlying disease biology with a novel mechanism of action, this subcutaneous therapy has the potential to introduce a new treatment approach that combines clinical efficacy and a favourable safety profile with the convenience of at-home administration.”

Taken together, the pivotal Phase III SatraGO programme demonstrated that Enspryng delivered consistent and clinically meaningful gains across the key signs and symptoms of thyroid eye disease, with a safety profile that compared favourably against currently available treatments. Turning to the primary endpoint of proptosis response at week 24, 53% of patients receiving Enspryng in SatraGO-2 achieved a reduction in eye bulging compared to 23% of those on placebo, reaching statistical significance. In SatraGO-1, 49% of patients treated with Enspryng achieved a proptosis response against 31% in the placebo arm, a meaningful numerical improvement that narrowly fell short of statistical significance, though the findings still add confirmatory weight to the overall picture of satralizumab’s potential in this setting. Across both studies, Enspryng also drove notable gains in secondary measures, with reductions in clinical activity score recorded in 78% to 90% of patients with active thyroid eye disease, and improvements in double vision observed in 44% to 61% of patients with active disease across SatraGO-1 and SatraGO-2 respectively.

---

---

Related Topics and Keywords

ENSPRYNG, Roche, thyroid, thyroid eye disease