argenx reported positive topline results from the Phase 3 ADAPT OCULUS trial evaluating VYVGART (efgartigimod alfa and hyaluronidase-qvfc) in adults with ocular myasthenia gravis. The randomized, double-blind, placebo-controlled study (n=141) met its primary endpoint, showing a statistically significant improvement versus placebo in MGII patient-reported ocular scores at Week 4 (p=0.012). The company said the trial data will be presented at an upcoming medical meeting and will support a planned supplemental Biologics License Application submission to the FDA to expand the product label into ocular myasthenia gravis.
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