Findings from the phase 3 ADAPT OCULUS trial support the efficacy of efgartigimod alfa and hyaluronidase-qvfc (Vyvgart) in patients with ocular myasthenia gravis (MG), argenx announced in a recent press release.
Patients receiving the drug experienced significant improvements in double vision and eyelid drooping compared with participants taking a placebo.
“ADAPT OCULUS is the first registrational study specifically designed to evaluate a targeted therapy for ocular myasthenia gravis,” said Dr. Luc Truyen, chief medical officer at argenx. “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.”
The study included 141 adults with ocular MG across North America, Europe and Asia. In the first portion, individuals were randomized to receive efgartigimod or a placebo as a once-weekly injection for four weeks. In the second portion, all participants were offered efgartigimod for two four-week cycles, with a four-week break between cycles.
Read more about MG therapies
At Week 4 of the study, individuals in the treatment group had an 4.04-point improvement, on average, in MG Impairment Index ocular subscore from baseline. Participants in the placebo group, on the other hand, experienced a mean improvement of 1.99 points. In addition, participants tolerated the drug well, and the authors did not observe any new side effects.
Argenx will present more data from the ADAPT OCULUS trial at an upcoming medical conference. The company plans to use these results in a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA). If approved, ocular MG would be added to the list of indications for the treatment.
The FDA approved efgartigimod in 2021 for adults with generalized MG who are anti-acetylcholine receptor (AChR) antibody-positive.
Sign up here to get the latest news, perspectives, and information about MG sent directly to your inbox. Registration is free and only takes a minute.
