Viridian Therapeutics’ Lumvoa is the first FDA-approved treatment for thyroid eye disease that includes data for both active and chronic forms of the illness.
The FDA has signed off on Viridian Therapeutics’ intravenous therapy veligrotug-vvze for the treatment of thyroid eye disease regardless of disease activity. The drug, which will now carry the brand name Lumvoa, is Viridian’s first commercial product.
The approval, announced on Friday evening, “marks the defining inflection for VRDN shares,” Truist Securities told investors on Sunday. “A broad, favorable label anchors the launch,” the analysts added, noting that Lumvoa “is the first approved TED [thyroid eye disease] treatment with labelling that includes data for both active and chronic disease.”
Such a broad label, the firm continued, is backed by “robust” data from the Phase 3 THRIVE program, which also served as the basis for its approval. A December 2024 readout from THRIVE-2, for instance, demonstrated a 48% placebo-adjusted proptosis responder rate (PRR)—a statistically significant effect. Proptosis is a common TED symptom that refers to the abnormal bulging of the eyes.
A few months later, long-term data from a separate study called THRIVE showed that 70% of patients with proptosis response at 15 weeks maintained this through 52 weeks of follow-up.
Taken together, the THRIVE program “underscores a differentiated clinical profile, with a rapid and durable treatment effect” for Lumvoa, Truist said.
Viridian is “hitting the ground running” in terms of Lumvoa’s launch, added the firm, which spoke to the biotech’s management. Indeed, Viridian said in its Friday release that Lumvoa will be available “immediately,” adding that physicians can start prescribing the drug “tomorrow.”
As Lumvoa enters the market, it will compete with Amgen’s Tepezza, approved for TED in 2020. In the fourth quarter of 2025, Tepezza dipped 1% year-on-year to $457 million. To turn the franchise around, Amgen is developing a subcutaneous formulation of the drug, which in April showed a 76.7% PRR at 24 weeks.
“We believe that the availability of the SC option could help the Tepezza franchise return to growth,” William Blair wrote in a note on April 6. Tepezza made $490 million in Q1, up 29% from the same period last year.
Outside of Lumvoa, Viridian is also advancing the anti-IGF1R antibody elegrobart, also for TED. In March, the asset led to significant improvements in proptosis but fell short of investor expectations. Placebo-adjusted PRRs hit 36% in patients treated monthly and 45% in those dosed every eight weeks. These findings fell “below the 51%-73% range that investors were looking for heading into the readout,” William Blair analysts said in a March 30 note.
Viridian is nevertheless pushing elegrobart forward, with a filing planned for the first quarter of 2027, according to the company’s Friday release.
