Subcutaneous Efgartigimod Improved Symptoms of Ocular Myasthenia Gravis in Phase 3 Study

For adults with ocular myasthenia gravis (oMG), treatment with Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc; Argenx, Amsterdam, Netherlands) demonstrated statistically significant improvement in patient-reported ocular symptoms compared with placebo at week 4, meeting the primary end point of the phase 3 ADAPT OCULUS clinical trial (NCT06558279). According to a statement from Argenx, the results are expected to support a planned supplemental Biologics License Application (BLA) submission to the Food and Drug Administration (FDA) to expand the drug’s label into oMG. Vyvgart Hytrulo is currently approved for the treatment of adults with anti-acetylcholine receptor antibody positive (AChR+) generalized myasthenia gravis (gMG) or chronic inflammatory demyelinating polyneuropathy (CIDP).

ADAPT OCULUS was a randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that included 141 adults with Myasthenia Gravis Foundation of America (MGFA) Class I oMG across North America, Europe, and Asia-Pacific. During the double-blind phase, participants were randomized 1:1 to receive 4 once-weekly subcutaneous injections of Vyvgart Hytrulo or placebo via prefilled syringe, followed by 4-weeks of follow-up. The primary end point was change in the Myasthenia Gravis Impairment Index (MGII) patient-reported outcome (PRO) ocular score from baseline to week 4, evaluating the severity of diplopia and ptosis.

Key findings include the following:

• Mean change from baseline in MGII PRO ocular score at week 4 was -4.04 points with Vyvgart Hytrulo vs -1.99 points with placebo (between-group difference, -2.05 points; P=.012).
• Treatment was associated with reductions in key ocular symptoms, including diplopia and ptosis.
• Vyvgart Hytrulo was well tolerated, with a safety profile consistent with prior studies and no new safety concerns identified.

Source: Argenx. Argenx announces positive topline results from phase 3 ADAPT OCULUS trial of Vyvgart in oracular myasthenia gravis. Argenx Newsroom. Published 26 February, 2026. Accessed 26 February, 2026. https://argenx.com/news/2026/press-release-3245183.html