Argenx Announces Positive Results for Vyvgart in Ocular Myasthenia
Argenx laboratory revealed on Thursday the positive results of its phase 3 ADAPT OCULUS clinical trial evaluating Vyvgart in the treatment of ocular myasthenia in adults. The study met its primary efficacy endpoint with a statistically significant improvement in symptoms.
Detailed Study Results
Argenx announced on Thursday the positive outcomes of the ADAPT OCULUS trial, a phase 3 study evaluating Vyvgart, a combination of efgartigimod alfa and hyaluronidase qvfc, in adult patients with ocular myasthenia. The study achieved its primary efficacy endpoint with a p-value of 0.012. Patients treated with Vyvgart showed an average improvement of 4.04 points at week 4 on the MGII Patient Reported Outcome scale for ocular symptoms, compared to 1.99 points for the placebo group. Patients in the Vyvgart group also recorded a significant reduction in two key symptoms: diplopia, or double vision, and ptosis, which is the drooping of the upper eyelids. The drug demonstrated a favorable tolerance profile, with no new safety issues identified compared to previous studies.
Trial Design and Scope
The ADAPT OCULUS trial is described as the first registration trial specifically designed to evaluate a targeted therapy for ocular myasthenia. The study was conducted as a double-blind, placebo-controlled trial involving 141 adults with class I MGFA ocular myasthenia, recruited across North America, Europe, and Asia-Pacific. Participants received four weekly injections of efgartigimod or placebo in Part A, followed by a four-week follow-up. Part B offered an open-label extension with two four-week cycles of efgartigimod injections. The study included both seropositive and seronegative patients for AChR antibodies. Participants were on a stable regimen of acetylcholinesterase inhibitors, corticosteroids, or non-steroidal immunosuppressive drugs.
Understanding Ocular Myasthenia
Ocular myasthenia is a rare and chronic disease characterized by muscle weakness limited to the muscles controlling the eyes and eyelids. Approximately 80% of patients with myasthenia gravis initially present with ocular symptoms, and up to 92% experience them during their disease. In 15 to 25% of patients, the weakness remains confined to the ocular muscles. Currently, no targeted therapy is specifically approved for ocular myasthenia, with therapeutic approaches relying on symptomatic treatments and general immunosuppression. Argenx plans to present the data from the ADAPT OCULUS trial at an upcoming medical conference. The group expects to submit a supplemental application to US authorities before the end of the third quarter of 2026.
