Argenx announces ADAPT OCULUS Phase 3 met primary endpoint

Argenx reported that the Phase 3 ADAPT OCULUS study of Vyvgart met its primary endpoint in ocular myasthenia gravis, and the company plans to use the results to support a supplemental Biologics License Application to the U.S. Food and Drug Administration.

Argenx announced new data presented at the 2026 American Academy of Neurology meeting in Chicago. The company reported that the Phase 3 ADAPT OCULUS study of Vyvgart met its primary endpoint in patients with ocular myasthenia gravis. Argenx also presented broader neuromuscular program updates and said it plans to use the OCULUS results to support a supplemental Biologics License Application to the U.S. Food and Drug Administration. Key facts: - The article reports ADAPT OCULUS met its primary endpoint, with treated patients reported to show improvement in ocular symptoms such as double vision and eyelid droop. - The company plans to use the OCULUS results in a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration to seek an expanded label for Vyvgart in ocular myasthenia gravis. - Presentations at the AAN meeting also included updates on other Phase 3 programs and adolescent trial results, as reported. Summary: The reported OCULUS result adds to Argenx's neuromuscular clinical program and is identified as the basis for a planned regulatory filing. The next stated procedural step is the planned submission of a supplemental BLA to the U.S. FDA.