The FDA has announced the approval of the first treatment for thyroid eye disease (TED) with labelling that includes data for both active and chronic TED, with the approval of veligrotug-vvze (Lumvoa; Viridian).
According to an article in the American Journal of Managed Care (AJMC), the treatment can be used to address the autoimmune disease that causes inflammation and tissue remodeling.
TED is a rare disorder that primarily affects tissues around the eyes. Symptoms can include dry eyes, bulging eyes, light sensitivity, difficulty moving your eyes, and double vision.
More severe cases can lead to vision loss.
The AJMC said the approval of veligrotug could help in addressing the condition before symptoms progress.
It is based off results from the phase 3 THRIVE and THRIVE-2 trials, which evaluated patients with active and chronic TED, respectively.
In the THRIVE trial, patients received either the 10 mg/kg veligrotug or placebo doses, involving five intravenous (IV) infusions every three weeks for 5 intravenous (IV) infusions.
Improvements were seen as early as week three, and week 15 saw significantly greater response.
The THRIVE-2 trial evaluated patients with chronic TED; they too received either the 10 mg/kg dose of veligrotug or placebo.
This trial saw similar results as THRIVE, and treatment-related adverse events were mild, with muscle spasms and menstrual disorders being the most reported by participants.
“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,” said Dr Michael Yen, an investigator in the THRIVE program.
Viridian Therapeutics said it aimed to make veligrotug available as soon as possible as the first commercial product for TED that the company has released.
