Argenx SE (NASDAQ:ARGX) on Thursday announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART in adults with ocular myasthenia gravis (oMG).
It is an autoimmune disorder where antibodies disrupt nerve-muscle communication, causing variable, fatiguing weakness of eye muscles and eyelids (ptosis) and double vision (diplopia).
The study met its primary endpoint, demonstrating statistically significant improvement in patient-reported outcomes.
Argenx Says Vyvgart Improves Double Vision
The ADAPT OCULUS study showed that patients treated with Vyvgart experienced a mean improvement of 4.04 points in Myasthenia Impairment Index scores compared to a 1.99 point improvement in the placebo group, with a p-value of 0.012.
This trial is particularly significant as it is the first registrational study designed to evaluate a targeted therapy for ocular myasthenia gravis, addressing a substantial unmet need in the treatment landscape.
The safety profile of Vyvgart was consistent with prior studies, with no new safety concerns identified.
Patients treated with Vyvgart experienced a marked reduction of key ocular symptoms: diplopia (double vision) and ptosis (drooping …