Waltham, Mass.– Viridian Therapeutics has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its lead drug candidate veligrotug (“veli”) for the treatment of Thyroid Eye Disease (TED), marking a major milestone in the company’s effort to bring a novel therapy to patients with both active and chronic forms of the condition.
The designation follows strong results from Viridian’s pivotal Phase 3 trials—THRIVE and THRIVE-2—which showed veligrotug achieved statistically significant improvements across all primary and secondary endpoints. In chronic TED, the drug demonstrated the first clinically meaningful and statistically significant resolution of diplopia (double vision) in a global Phase 3 trial. It also showed a rapid proptosis response, with measurable improvement as early as three weeks after a single infusion.
“This designation affirms the transformative potential of veli and its promise to become a treatment-of-choice for TED,” said Steve Mahoney, president and CEO of Viridian. “It’s the only therapy to show such compelling and consistent results for diplopia in both active and chronic TED, and we believe it fills a critical gap left by current treatment options.”
Breakthrough Therapy Designation is intended to expedite the development and review of drugs that may offer substantial improvement over existing treatments for serious or life-threatening diseases. The designation also opens the door for potential Priority Review, which could accelerate veligrotug’s path to market.
Viridian plans to submit a Biologics License Application (BLA) for veligrotug in the second half of 2025, with a potential U.S. launch in 2026, pending FDA approval.
The THRIVE and THRIVE-2 trials represent the largest clinical program to date for TED. Veligrotug was generally well-tolerated across both studies, further supporting its promise as a new therapeutic option for patients living with this debilitating autoimmune condition.
