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Oculis Announces European Medicines Agency PRIME Designation for Privosegtor, Advancing a Potential First‑in‑Class Neuroprotective Candidate for Optic Neuritis
ZUG, Switzerland, March 31, 2026 (GLOBE NEWSWIRE) -- PRIME designation follows recent Breakthrough Therapy designation from the U.S. FDA, underscoring the
About this update from Oculis Holding Ag
[{"type":"text","content":"ZUG, Switzerland, March 31, 2026 (GLOBE NEWSWIRE) -- 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 Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced that its neuroprotective candidate Privosegtor has been granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) for the treatment of optic neuritis (ON), a rare, sight-threatening condition that is often a relapse of multiple sclerosis or its first clinical manifestation. This decision follows the recent granting of Breakthrough Therapy designation for Privosegtor for the treatment of ON, by the U.S. Food and Drug Administration (FDA) announced in January 2026, reinforcing global regulatory support. The EMA grants PRIME designations to only a small, selective number of programs each year. They provide early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or provide benefits to patients without treatment options. These medicines are considered priority medicines by the EMA, which aims to optimize development plans and expedite evaluations so that medicines addressing significant unmet medical needs can reach patients faster. Privosegtor also has Orphan Drug status from both the EMA and the FDA for ON. Privosegtor, a novel peptoid small molecule that crosses both the blood–brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuropathies. These serious conditions carry a significant unmet need, because they can lead to permanent vi...