argenx expands VYVGART into ocular MG as profitability signals franchise maturity

The company reported that its Phase 3 ADAPT OCULUS trial met its primary endpoint. The study evaluated VYVGART® (efgartigimod alfa and hyaluronidase-qvfc) in adults living with ocular myasthenia gravis.

Ocular myasthenia gravis is a rare autoimmune condition in which muscle weakness affects only the eyes and eyelids. While most patients with myasthenia gravis initially present with ocular symptoms, 15–25% remain restricted to ocular disease. Despite its impact on daily functioning, there are currently no approved targeted therapies specifically for oMG.

In practical terms, the data indicate that argenx’s lead product can reduce eye-related symptoms in patients whose disease is limited to ocular muscles, a group for which no targeted therapies are currently approved. By meeting its primary endpoint in a dedicated Phase 3 study, argenx lays the regulatory groundwork for expanding VYVGART into this segment of the myasthenia gravis market.

In the trial, patients receiving VYVGART showed a statistically significant improvement in ocular symptoms compared with placebo at Week 4. On the Myasthenia Gravis Impairment Index (MGII) ocular patient-reported score, the treatment group improved by 4.04 points on average, compared with a 1.99-point improvement in the placebo group. According to the company, this translated into a marked reduction in key symptoms such as double vision (diplopia) and drooping eyelids (ptosis). No new safety concerns were identified, and the safety profile was consistent with previous studies.

Addressing an unmet need

“Ocular myasthenia gravis significantly impacts patients’ daily lives, affecting vision, independence and the ability to do routine tasks, such as work or drive a car. Yet today, there are no approved targeted medicines for this disease,” said Carolina Barnett-Tapia, M.D., Ph.D., Associate Professor of Medicine (Neurology) at the University of Toronto. “The improvements observed with VYVGART in the OCULUS trial offer hope to the thousands of myasthenia gravis patients with ocular involvement.”

Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx, added: “ADAPT OCULUS is the first registrational study specifically designed to evaluate a targeted therapy for ocular myasthenia gravis. Ocular MG has been historically under-studied and represents a significant unmet need in the MG community. These positive results deliver on our patient-centered approach to drug development and bring us one step closer to our vision of delivering a targeted, transformative treatment option to as many MG patients as possible and ensuring no patient is left behind.”

argenx said the results support a planned supplemental Biologics License Application submission to the U.S. Food and Drug Administration to expand the VYVGART label into ocular MG.

First year of operating profitability

The clinical update was released alongside the company’s full-year 2025 financial results. argenx reported $1.3 billion in global product net sales in the fourth quarter and $4.2 billion for the full year, representing 90% year-over-year growth. The company delivered $1.1 billion in operating income in 2025, marking its first year of operating profitability.

“argenx delivered another standout year of execution in 2025,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We reached 19,000 patients globally with VYVGART, expanded our impact across gMG and CIDP through the successful launch of the pre-filled syringe, and made substantial progress across our development programs.”

“2026 is another year of expansion for argenx,” he continued. “Positive data in ocular MG and the priority review of our seronegative gMG filing bring us closer to reaching even more MG patients with the broadest possible label, reinforcing our leadership in shaping the MG market. Momentum across our FcRn portfolio, including expansion into rheumatology, together with continued progress across our broader pipeline with empasiprubart, adimanebart and new first-in-class candidates from our Immunology Innovation Program, supports our next horizon of growth toward Vision 2030 and beyond.”

Expanding the MG franchise

argenx is awaiting a regulatory decision in anti-acetylcholine receptor antibody-negative (seronegative) generalized myasthenia gravis, with a PDUFA target action date of May 10, 2026.

Beyond myasthenia gravis, the company continues to advance additional development programs. Topline results in primary immune thrombocytopenia are expected in the fourth quarter of 2026. Registrational studies are ongoing in rheumatology indications, with further data expected over the coming years. A registrational study in Graves’ disease is expected to initiate in 2026.

Under its “Vision 2030” strategy, argenx aims to treat 50,000 patients globally, secure ten labeled indications across approved medicines, and progress five pipeline candidates into Phase 3 development by 2030.

With positive Phase 3 data in ocular MG and its first profitable year, argenx is broadening the reach of VYVGART while reinforcing its evolution into a commercially sustainable immunology franchise.