Oculis Holding AG announced that its neuroprotective candidate Privosegtor has been granted U.S. Food and Drug Administration Breakthrough Therapy Designation for the treatment of optic neuritis, a rare sight‑threatening condition that can lead to permanent vision loss.
The designation is based on Phase 2 ACUITY trial data that showed an average gain of 18 letters in low‑contrast letter acuity at three months—well above the 15‑letter threshold considered clinically meaningful—and preserved retinal and optic nerve structure versus placebo.
Privosegtor is a peptoid small‑molecule engineered to cross both the blood–brain and retinal barriers, giving it a unique pharmacologic profile among neuro‑ophthalmic therapies. The breakthrough status unlocks priority review, rolling submissions, and dedicated FDA guidance, potentially shortening the path to approval by up to 18 months.
CEO Riad Sherif said the designation “underscores Privosegtor’s potential as the first neuroprotective therapy for optic neuritis” and highlighted the company’s commitment to expanding the PIONEER program, which includes three pivotal trials for optic neuritis and non‑arteritic anterior ischemic optic neuropathy.
The announcement has already spurred a positive market reaction, with Oculis shares rising 9% in pre‑market trading, reflecting investor confidence in the accelerated development timeline and the estimated $7 billion U.S. market for optic neuropathies.
With the breakthrough designation, Oculis is positioned to de‑risk its development program, accelerate regulatory engagement, and potentially capture a significant share of the unmet medical need in neuro‑ophthalmology.
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