Oculis Receives European Medicines Agency PRIME Designation For Privosegtor In Optic Neuritis, Accelerating PIONEER Registrational Program Across Three Global Trials

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Oculis Holding AG

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  • 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
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