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The FDA on June 26, 2026 approved Lumvoa (veligrotug-vvze), Viridian Therapeutics' intravenous antibody, for adults with thyroid eye disease, without restricting its use by disease activity or duration.
Veligrotug is a humanized IgG1 antibody against IGF-1R that blocks ligand-induced receptor autophosphorylation. The label is careful to state that its mechanism in thyroid eye disease has not been fully characterized.
Two trials read out at week 15. In active disease, 70% of 75 patients on Lumvoa met the proptosis responder definition against 5% of 38 on placebo, with average proptosis falling 2.9 mm against 0.5 mm. In chronic disease, responder rates were 57% of 125 patients against 8% of 63. Diplopia resolved in 49% of patients against 12% in the active trial and 32% against 14% in the chronic one.
Hearing impairment sits among the reactions reported in 5% or more of patients.
Teprotumumab, also an IGF-1R antibody, was approved for thyroid eye disease in 2020. The Lumvoa label sets no limit by disease activity or duration. Response was measured at week 15 in the labeled population.
Sources: FDA prescribing information; Drugs@FDA, BLA 761530; Viridian Therapeutics press release; Ophthalmology Times
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