argenx Pursues FDA Label Expansion after VYVGART’s 4.04-Point Improvement in Phase 3 oMG Trial
argenx reported positive Phase 3 ADAPT OCULUS results showing VYVGART improved MGII PRO ocular scores by 4.04 points versus 1.99 for placebo (p=0.012) at Week 4 in patients with ocular myasthenia gravis. These data support a planned supplemental BLA submission to the FDA to expand VYVGART’s label into oMG as the first targeted treatment for this indication.
1. Trial Design and Objectives
The ADAPT OCULUS study is a Phase 3, randomized, double-blind, placebo-controlled trial enrolling 141 adult patients with ocular myasthenia gravis across North America, Europe and Asia-Pacific. Participants in Part A received four once-weekly subcutaneous injections of VYVGART or placebo, with efficacy assessed by the change from baseline in the Myasthenia Gravis Impairment Index (MGII) ocular patient-reported outcome at Week 4.
2. Efficacy Results
VYVGART met the primary endpoint with a statistically significant improvement in MGII PRO ocular scores (mean change 4.04 points) versus 1.99 points for placebo (p=0.012). Patients experienced marked reductions in key ocular symptoms, including diplopia and ptosis, demonstrating the therapy’s targeted efficacy in oMG.
3. Safety Profile and Next Steps
VYVGART was well tolerated with no new safety signals identified, maintaining a safety profile consistent with prior studies. Argenx plans to submit a supplemental BLA to the FDA to secure label expansion into ocular myasthenia gravis, positioning VYVGART as the first registrational therapy for this under-served indication.