Key Takeaways

  • The FDA has approved Lumvoa (veligrotug-vvze) for thyroid eye disease (TED), giving Viridian Therapeutics its first commercial product
  • Approval was based on the phase 3 THRIVE and THRIVE-2 trials, which met all primary and secondary endpoints in active and chronic TED
  • Lumvoa becomes the second FDA-approved pharmacologic treatment for TED
  • Viridian plans an immediate US launch

The FDA has approved Viridian Therapeutics' Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED). The approval of Lumvoa, a new insulin-like growth factor-1 receptor (IGF-1R) antagonist, marks the first FDA-approved therapy for TED with labeling that includes data in both active and chronic disease.

TED is characterized by inflammation and tissue remodeling of the tissues surrounding the eye, which can result in proptosis, diplopia, pain, and vision impairment. According to Viridian, Lumvoa was designed to address the needs of patients across the disease spectrum while reducing treatment burden through a 12-week treatment course.

"With the approval of Lumvoa, we take a significant step forward in providing a meaningful treatment option for people living with thyroid eye disease," said Steve Mahoney, president and CEO of Viridian. "Lumvoa was designed with patient needs at the forefront and is Viridian's first FDA-approved medicine and our first commercial product."

Viridian said it plans to launch Lumvoa immediately, with physicians able to begin prescribing the therapy the day after approval. To support commercialization, the company has established the ViridianCares patient support program, which will provide insurance navigation, benefits verification, patient access support, and financial assistance programs for eligible patients.

The approval was supported by results from the pivotal phase 3 THRIVE and THRIVE-2 clinical trials, which evaluated Lumvoa in patients with active and chronic TED, respectively. According to the company, both studies met their primary and all secondary endpoints, demonstrating statistically significant improvements across key clinical measures at week 15.

Patients in both trials received a five-infusion regimen completed over 12 weeks. Viridian reported that reductions in proptosis were observed as early as 3 weeks after treatment initiation. The company also stated that Lumvoa is the first approved TED therapy to demonstrate statistically significant improvements in both diplopia response and complete diplopia resolution in patients with active and chronic disease.

"The Lumvoa development program was a robust evaluation of the drug across the full spectrum of TED, including both active and chronic disease, showing significant improvements in outcomes that matter to patients and clinicians," said Michael Yen, MD, professor of oculoplastic surgery and ophthalmology at Baylor College of Medicine and an investigator in the THRIVE program. "It's encouraging to see a new treatment for the full spectrum of the disease with data showing rapid onset of proptosis reduction as well as improvements in diplopia."

Christine Gustafson, founder, chief executive officer, and executive director of the TED Community Organization, welcomed the approval, noting that TED can have profound physical and emotional effects on patients and that additional treatment options are needed.

Lumvoa becomes the second FDA-approved pharmacologic treatment for TED. Horizon Therapeutics received FDA approval for Tepezza (teprotumumab) in January 2020. In 2023, Amgen acquired Horizon in 2023 for $27.8 billion, gaining rights to Tepezza.