The US Food and Drug Administration has approved veligrotug-vvze (Lumvoa) for the treatment of thyroid eye disease, according to a press release from Viridian Therapeutics. The indication includes patients regardless of disease activity or duration.
Thyroid eye disease (TED) is an autoimmune disease characterized by inflammation and tissue remodeling around and behind the eyes that can result in proptosis, diplopia, pain, and vision impairment. Viridian said the treatment will be available immediately following approval and announced ViridianCares, a patient support program that provides patient access liaisons, insurance support, benefit verification, and financial assistance for eligible patients.
The approval was supported by the phase 3 THRIVE trial in patients with active TED and the phase 3 THRIVE-2 trial in patients with chronic TED. According to the company, both trials met their primary and secondary endpoints at week 15. Patients received 5 intravenous infusions administered every 3 weeks over a 12-week treatment course. Viridian reported reductions in proptosis as early as 3 weeks following treatment initiation. Viridian also stated that Lumvoa showed statistically significant effects on diplopia response and complete resolution of diplopia in the phase 3 trials.
Michael Yen, MD, of Baylor College of Medicine and an investigator in the THRIVE program, said, “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."
According to safety information included in the release, Lumvoa carries warnings for infusion reactions, inflammatory bowel disease exacerbation, hyperglycemia, and hearing impairment, including hearing loss that may be permanent. Infusion reactions occurred in approximately 9% of treated patients, and hyperglycemia occurred in 12%. Approximately one-half of those patients had preexisting diabetes or impaired glucose tolerance. The most common adverse reactions were muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reactions, nausea, nasopharyngitis, increased blood creatine phosphokinase, dry skin, and hypertension. Females of reproductive potential should use effective contraception before treatment, during treatment, and for 6 months following the final dose.
Viridian also said subcutaneous elegrobart, an investigational therapy for TED, remains on track for a biologics license application submission in the first quarter of 2027.
Source: Viridian Therapeutics
