Viridian Therapeutics launched Lumvoa after FDA approval for thyroid eye disease. The drug enters a market dominated by Amgen's Tepezza. First sales data due early 2026.
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Viridian Therapeutics (VRDN) launched its first commercial product over the weekend, hours after the U.S. Food and Drug Administration approved Lumvoa for thyroid eye disease. The intravenous therapy targets a condition with only one other approved drug, Amgen's Tepezza.
Thyroid eye disease is an autoimmune disorder that can cause bulging eyes, double vision, and vision loss. It affects women at five times the rate of men and is most common in people with Graves' disease. Smoking is a major risk factor.
Tepezza, approved in 2020, became the standard of care and generated billions in sales. Amgen acquired Horizon Therapeutics, Tepezza's original owner, for $28 billion in 2023. The label includes warnings about hearing impairment and other side effects.
Lumvoa uses a different antibody targeting the same IGF-1 receptor as Tepezza. Viridian has said it may have a better safety profile. The company has not released head-to-head data.
The FDA approved Lumvoa based on a Phase 3 trial that showed it reduced proptosis, or eye bulging, compared with placebo. Viridian reported those results in 2024 and received priority review status. The decision arrived ahead of the target action date, a positive sign for the company.
Viridian built a sales force and plans to target the same specialists who prescribe Tepezza: ophthalmologists and endocrinologists. The company needs to secure insurance coverage and negotiate pricing. Tepezza's list price is roughly $30,000 per infusion. Viridian has not disclosed Lumvoa's price.
Amgen's Tepezza sales have declined from their peak. Several other companies are developing thyroid eye disease therapies, including subcutaneous formulations that could compete with Lumvoa's intravenous-only positioning. Viridian itself has an early-stage subcutaneous version.
The fourth-quarter earnings report, due in early 2026, will show the first Lumvoa revenue numbers.
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