Oculis因治疗视神经炎的Privosegtor获得欧洲药品管理局PRIME称号，加速了三项全球试验的PIONEER注册计划

2026-03-31 16:10

PRIME designation follows recent Breakthrough Therapy designation from the U.S. FDA, underscoring the importance and urgency of addressing optic neuritis, a serious condition that can have negative long-term visual outcomes, significantly affecting function and quality of life
Decision supported by positive Phase 2 ACUITY data showing substantial improvements in vision combined with anatomical and biological neuroprotective benefits in patients treated with Privosegtor
Strong regulatory momentum bolsters the global development strategy, with PIONEER registrational program in optic neuropathies underway, potentially providing Privosegtor with an accelerated regulatory pathway