WALTHAM, Mass., June 26, 2026
Viridian Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (TED), making it the first FDA-approved therapy with labeling covering both active and chronic TED. The approval marks a major commercial milestone as Viridian’s first FDA-approved medicine and first commercial product. Supported by positive results from the pivotal Phase 3 THRIVE and THRIVE-2 clinical trials, Lumvoa demonstrated rapid, consistent, and durable improvements in the key signs and symptoms of TED, including proptosis reduction and diplopia improvement. Following approval, Viridian confirmed an immediate U.S. launch, allowing physicians to begin prescribing Lumvoa while supporting patients through the newly established ViridianCares™ patient assistance program.
Phase 3 Trials Demonstrate Strong Efficacy Across Active and Chronic TED
The FDA approval was based on data from the THRIVE study in active thyroid eye disease and THRIVE-2 in chronic thyroid eye disease, with both pivotal Phase 3 trials successfully meeting their primary and all secondary endpoints. Lumvoa, a full insulin-like growth factor-1 receptor (IGF-1R) antagonist, demonstrated clinically meaningful reductions in proptosis as early as three weeks after treatment initiation and maintained improvements through a 12-week treatment course consisting of five intravenous infusions. Importantly, Lumvoa became the first approved TED therapy to demonstrate statistically significant improvements in both diplopia response and complete diplopia resolution across patients with both active and chronic disease. The FDA previously granted Breakthrough Therapy Designation and Priority Review, recognizing the therapy’s potential to address a significant unmet medical need.
Safety Profile and Patient Access Support Immediate Commercial Launch
Clinical studies showed that Lumvoa was generally well tolerated, with the most common adverse events including muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, infusion-related reactions, nausea, dry skin, and hypertension. The prescribing information also highlights important safety considerations involving infusion reactions, inflammatory bowel disease exacerbation, hyperglycemia, and hearing impairment, requiring appropriate monitoring throughout treatment. To ensure rapid patient access, Viridian has introduced ViridianCares™, a comprehensive patient support program offering insurance verification, reimbursement assistance, financial support for eligible patients, and dedicated patient access liaisons, helping physicians and patients navigate treatment from the first prescription.
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Viridian Expands Leadership in Thyroid Eye Disease Pipeline
The FDA approval establishes Viridian Therapeutics as a commercial-stage biotechnology company while strengthening its long-term strategy in autoimmune diseases. Beyond Lumvoa, the company continues advancing elegrobart, an investigational subcutaneous therapy for thyroid eye disease, with a Biologics License Application (BLA) submission planned for the first quarter of 2027. Designed to improve patient convenience through subcutaneous administration, elegrobart represents the next phase of Viridian’s TED franchise. With Lumvoa now commercially available and a late-stage pipeline progressing toward regulatory submission, Viridian aims to expand treatment options for patients living with thyroid eye disease, a rare autoimmune condition that can cause vision impairment, inflammation, eye bulging, pain, and double vision.
Source: Viridian Therapeutics press release
