Waltham, Mass. — Viridian Therapeutics Inc. announced that the U.S. Food and Drug Administration has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease, making it the biotechnology company’s first FDA-approved and commercial product.
Thyroid eye disease, or TED, is a rare autoimmune disorder characterized by inflammation and tissue remodeling around and behind the eyes. The condition can cause eye bulging, double vision, pain and impaired vision.
Viridian plans to launch Lumvoa immediately, with physicians able to begin prescribing the treatment Tuesday.
“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 Chief Executive Officer of Viridian. “Lumvoa was designed with patient needs at the forefront and is Viridian’s first FDA-approved medicine and our first commercial product. This marks an important milestone for us and reflects years of focused execution by the Viridian cross-functional teams. Our commercial and medical affairs teams have been preparing for this moment for a long time, and in particular since receiving Breakthrough Therapy Designation last year. We are ready to support patients and physicians from day one.”
The FDA approval was granted under Priority Review and was supported by the pivotal Phase 3 THRIVE and THRIVE-2 clinical trials, which evaluated Lumvoa in patients with active and chronic TED, respectively.
Both trials met their primary and all secondary endpoints, demonstrating statistically significant and clinically meaningful improvements at week 15 across key signs and symptoms of the disease.
Patients in both studies received a 12-week course of Lumvoa. Reductions in proptosis, or eye bulging, were observed as early as three weeks.
Lumvoa is a full antagonist of insulin-like growth factor-1 receptor, or IGF-1R, and is the first approved TED treatment with labeling that includes clinical data for both active and chronic forms of the disease. It is also the first approved TED product to demonstrate a statistically significant effect on both diplopia response and the complete resolution of double vision in active and chronic disease, according to Viridian.
“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, M.D., 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. This is an exciting new option for physicians to offer their TED patients.”
“The TED community is pleased to see this important advancement in the treatment of TED. TED can be physically painful and emotionally exhausting, and patients experience the disease as highly disruptive to their daily lives,” said Christine Gustafson, Founder, Chief Executive Officer, and Executive Director, TED Community Organization. “Having a new treatment available could be very important for the many patients who are seeking help for thyroid eye disease.”
Viridian has established ViridianCares, a patient support program offering access liaisons, insurance coverage assistance, benefit verification and financial assistance for eligible patients. The company said it has worked with insurers, healthcare providers and patient advocates to support access to Lumvoa.
The approval marks a major commercial milestone for Viridian as it continues developing subcutaneous elegrobart for TED. The company expects to submit a biologics license application for that treatment in the first quarter of 2027.
