Viridian Therapeutics Announces Positive Topline Results from Elegrobart Phase 3 REVEAL-1 Clinical Trial in Active Thyroid Eye Disease

Elegrobart Q4W and Q8W achieved clinically meaningful 54% and 63% proptosis responder rate versus 18% placebo at week 24

Mar. 31, 2026 at 1:18am

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Viridian Therapeutics announced positive topline data from the elegrobart REVEAL-1 phase 3 clinical trial in patients with active thyroid eye disease (TED). REVEAL-1 evaluated two dosing regimens of elegrobart, every four weeks (Q4W) and every eight weeks (Q8W), compared with placebo. The trial met its primary endpoint with high statistical significance, with elegrobart treatment driving robust proptosis responses in a convenient dosing regimen.

Why it matters

Elegrobart has the potential to be the first subcutaneous autoinjector treatment for TED, providing a more convenient and accessible option compared to the only currently marketed treatment which requires eight intravenous infusions. Positive results from REVEAL-1 suggest elegrobart could expand the TED treatment market and provide patients with an attractive new therapy.

The details

REVEAL-1 enrolled 132 patients and randomized them 1:1:1 to elegrobart Q4W, elegrobart Q8W, and placebo. The trial met its primary endpoint of Q4W proptosis responder rate with high statistical significance. Elegrobart Q4W and Q8W achieved clinically meaningful 54% and 63% proptosis responder rates versus 18% placebo at week 24. The trial also showed clinically meaningful improvements in diplopia, with 51% of patients in the Q4W arm achieving complete resolution versus 16% placebo.

  • REVEAL-1 topline data was reported on March 30, 2026.
  • REVEAL-2, a phase 3 trial evaluating elegrobart in chronic TED, is on track for topline readout in Q2 2026.
  • Viridian anticipates submitting a Biologics License Application (BLA) to the FDA for elegrobart in Q1 2027.

The players

Viridian Therapeutics

A biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases.

Prem Subramanian, MD, PhD

Professor of ophthalmology at Colorado University Anschutz and chief of neuro-ophthalmology at the Sue Anschutz-Rodgers Eye Center.

Steve Mahoney

President and Chief Executive Officer of Viridian Therapeutics.

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What they’re saying

“We are excited to report these results from REVEAL-1, the largest pivotal clinical trial conducted in active TED to date, which position elegrobart as potentially the first ever subcutaneous autoinjector treatment for TED.”

— Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics

“Subcutaneous elegrobart showed rapid and clinically meaningful reductions in proptosis and diplopia in REVEAL-1 with a highly convenient, well-tolerated dosing profile. Patients are seeking more treatment choices for TED, and there remains a clear need for a more conveniently administered therapy. I am very encouraged to see the data for elegrobart and believe it has the potential to reach more TED patients than an intravenous therapy and to provide them with an attractive treatment option.”

— Prem Subramanian, MD, PhD, Professor of ophthalmology at Colorado University Anschutz and chief of neuro-ophthalmology at the Sue Anschutz-Rodgers Eye Center

What’s next

REVEAL-2, a phase 3 clinical trial evaluating elegrobart in patients with chronic TED, is on track for topline readout in Q2 2026. Viridian anticipates submitting a Biologics License Application (BLA) to the U.S. FDA for elegrobart in Q1 2027.

The takeaway

The positive results from the REVEAL-1 trial position elegrobart as a potentially transformative treatment option for patients with active thyroid eye disease. If approved, elegrobart's convenient subcutaneous dosing and strong efficacy profile could significantly expand access to TED therapy and provide an attractive alternative to the current standard of care.