A new treatment called veligrotug has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) after participants in clinical trials saw significant improvements to thyroid eye disease (TED) symptoms. This designation may help fast-track its review and approval process to make the drug available as early as next year.

Veligrotug is a biologic that targets a protein called IGF-1R. This protein plays a role in the inflammation and tissue changes that cause TED symptoms like eye bulging and double vision. By blocking this protein, veligrotug helps reduce swelling and pressure behind the eyes. It’s given as an IV infusion through a vein, typically in the arm.

Veligrotug Helps Ease Symptoms in Hard-To-Treat TED

In two large clinical trials, veligrotug showed meaningful improvements in symptoms for people with both active and chronic forms of thyroid eye disease.

In a trial for people with active TED, 70 percent of participants who received veligrotug had reduced eye bulging compared to 5 percent of those who took a placebo (inactive treatment). More than half of the participants (54 percent) had complete resolution of double vision, compared to 12 percent of those who took a placebo.

In a separate trial for people with chronic TED — which has fewer treatment options — veligrotug again showed significant results. After five infusions over 15 weeks, 56 percent of participants had reduced eye bulging, compared to 8 percent who received a placebo. Additionally, 32 percent experienced complete resolution of double vision, compared to 14 percent on placebo.

Across both studies, side effects were mostly mild. Hearing issues occurred in a small percentage of participants, but serious side effects were rare.

A New TED Treatment on the Horizon?

TED can cause symptoms that interfere with vision and daily life, including eye pain, swelling, and double vision. There are several options for treating the condition, including corticosteroids, immunosuppressants, eye drops, and selenium tablets. However, there’s currently only one drug approved by the FDA for treating TED, a biologic called teprotumumab (Tepezza).

Teprotumumab works similarly to veligrotug. It’s also given as an IV infusion and targets the IGF-1R protein to relieve inflammation and reduce TED symptoms.

Now that veligrotug has secured breakthrough therapy designation, Viridian Therapeutics, the drug’s developer, plans to submit it to the FDA for approval later this year. It could be available as early as 2026.

If you’re living with TED and aren’t finding relief from your current treatment plan, speak with your doctor about what options are available. Together, you can develop a plan that meets your goals.

Learn about 11 treatment options available for TED.

Find Your Team

On TEDhealthteam, the social network for people living with thyroid eye disease and their loved ones, members come together to ask questions, give advice, and share their stories with others who understand life with TED.

Have you experienced double vision with TED? What has helped you manage your symptoms? Share your tips and experiences in a comment below, start a conversation on your Activities page, or connect with like-minded members in Groups.