FDA Clears Viridian’s Lumvoa as Second Approved Therapy for Thyroid Eye Disease

Viridian Therapeutics has received FDA approval for its thyroid eye disease therapy, becoming only the second approved treatment for this inflammatory condition and introducing a competitor with notable advantages over the existing Amgen product.

The therapy, Viridian’s inaugural commercial product, will be launched promptly, the Waltham, Massachusetts‑based biotech announced following Friday’s market close. Developed under the code name veligrotug (commonly called veli), the intravenous treatment will be sold under the brand name Lumvoa.

Thyroid eye disease (TED) is an autoimmune disorder characterized by inflammation of the tissues surrounding and behind the eyes, causing eye pain, redness, and vision impairment. The defining feature of TED is proptosis, the outward bulging of the eyes.

TED progresses through an active inflammatory phase, which can last months to years, and a subsequent stable or chronic phase where symptoms remain. The condition is driven by excess insulin‑like growth factor‑1 (IGF‑1), a hormone that promotes inflammation. Lumvoa is a monoclonal antibody that targets the IGF‑1 receptor, thereby inhibiting its signaling pathway.

Viridian’s regulatory filing for Lumvoa was supported by two randomized, placebo‑controlled Phase 3 trials—one evaluating patients in the active inflammatory stage and another in the chronic stable stage. Both studies demonstrated statistically and clinically significant improvements in TED signs and symptoms at week 15, with a reduction in proptosis evident as early as three weeks after treatment initiation.

The most frequently reported adverse events included muscle spasms, headaches, and potential permanent hearing loss. During the trials, 17 % of patients receiving Lumvoa experienced hearing impairment versus 6 % of placebo recipients. The product labeling requires clinicians to perform hearing assessments prior to, during, and following therapy.

Corticosteroids have traditionally been used off‑label to mitigate TED inflammation. Until Lumvoa’s approval, Amgen’s Tepezza was the sole FDA‑approved therapy for TED, also a monoclonal antibody targeting the IGF‑1 receptor. Both agents share a comparable safety profile, notably a risk of hearing loss. Lumvoa differentiates itself with a condensed dosing schedule: infusions last 30–45 minutes and are given five times at three‑week intervals, whereas Tepezza requires eight infusions of 60–90 minutes each over the same interval.

Approved in 2022, Tepezza became Horizon Therapeutics’ flagship product. Amgen’s $28 billion acquisition of Horizon in 2023 added Tepezza to its portfolio. In 2025, Tepezza generated $1.9 billion in sales for Amgen, reflecting a modest 3 % year‑over‑year increase.

Following the approval, Leerink Partners analyst Thomas Smith told investors that Lumvoa’s key advantages over Tepezza include a faster onset of action, prolonged durability, and reduced dosing frequency. Viridian is also advancing a subcutaneous candidate, elegrobart. Preliminary data from a Phase 3 study released last month showed that elegrobart achieved its primary endpoint, with comparable efficacy to the IV formulation at both four‑week and eight‑week dosing schedules. The company intends to submit a biologics license application for elegrobart in Q1 2027, with plans to deliver the therapy via an autoinjection device for home use.

“Overall, we view Viridian as well‑positioned to compete in the multi‑billion‑dollar thyroid eye disease market, as veli’s profile appears differentiated from Tepezza across efficacy, safety, and convenience, while elegrobart shows a promising competitive outlook for both active and chronic disease forms,” Smith commented.

Amgen is not alone in the pipeline; an ongoing Phase 1/2 trial is evaluating a subcutaneously administered antibody that targets the IGF‑1 receptor, aiming to provide stronger binding and blockade along with an extended half‑life.

Viridian has set an 8 a.m. Monday conference call to address the Lumvoa approval and its go‑to‑market strategy. Analyst Thomas Smith indicated that the call is expected to cover pricing details, anticipating that Lumvoa will be priced similarly to Tepezza, which lists at more than $18,000 per vial.

Photo: Karen Bleier /AFP, via Getty Images

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