Global biotech innovator argenx has announced that its Phase 3 ADAPT OCULUS study delivered positive topline results for VYVGART (efgartigimod alfa and hyaluronidase-qvfc) in adults with ocular myasthenia gravis (oMG).

 

The trial met its primary endpoint, showing statistically significant improvements in Myasthenia Impairment Index (MGII) Patient-Reported Outcome (PRO) ocular scores at Week 4. Patients receiving VYVGART experienced a mean 4.04-point improvement, compared with 1.99 points for those on placebo.

 

“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, 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.”

 

VYVGART was well tolerated, with a safety profile consistent with prior studies and no new safety concerns identified.

 

“ADAPT OCULUS is the first registrational study specifically designed to evaluate a targeted therapy for ocular myasthenia gravis,” said Luc Truyen, Chief Medical Officer of argenx. 

 

“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.”