October 14, 2025 | Zug, Switzerland — Oculis Holding AG (Nasdaq: OCS), a global biopharmaceutical company advancing therapies for ophthalmic and neuro-ophthalmic diseases, announced it will present key updates on its transformative late-stage pipeline at the Eyecelerator and American Academy of Ophthalmology (AAO) 2025 meetings. The presentations will cover Privosegtor, a novel neuroprotective agent for optic nerve diseases, OCS-01, a non-invasive treatment for diabetic macular edema, and Licaminlimab, a genotype-based therapy for dry eye disease.
Science Significance
Oculis’ late-stage portfolio underscores innovation in neuroprotection and ocular drug delivery. Privosegtor, a first-in-class peptoid small molecule, has shown neuroprotective activity in preclinical and Phase 2 studies for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy (NAION). It preserves retinal ganglion cells and supports functional recovery after inflammation. Meanwhile, OCS-01 eye drops, formulated with proprietary OPTIREACH® technology, deliver high-concentration dexamethasone to the retina, aiming to replace invasive intravitreal injections. Licaminlimab, a topical anti-TNFα therapy, integrates a genotype-based personalized medicine approach, advancing precision treatment for dry eye disease.
Regulatory Significance
Oculis has achieved critical regulatory milestones, including Orphan Drug Designations for Privosegtor from both the FDA and EMA, and positive FDA feedback advancing it into registrational trials. The OCS-01 Phase 3 DIAMOND program is underway, with topline data expected in mid-2026, while Licaminlimab’s PREDICT-1 trial will begin in late 2025. These studies position Oculis at the forefront of ophthalmic regulatory engagement and align with global standards for clinical efficacy and patient safety under ICH-GCP frameworks.
Business Significance
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This pipeline update strengthens Oculis’ strategic market positioning as a leader in ophthalmic drug innovation. Advancing three differentiated programs across distinct ocular conditions enhances its asset diversification and investor appeal. The company’s participation at AAO 2025 also provides visibility among clinicians and partners, supporting future commercial partnerships, funding rounds, and licensing deals. With late-stage assets nearing commercialization, Oculis demonstrates robust R&D maturity and strategic alignment for future market entry.
Patients’ Significance
Patients suffering from optic neuropathies, diabetic macular edema, and dry eye disease face chronic disability and limited effective therapies. Oculis’ non-invasive and neuroprotective approaches could reduce treatment burden, eliminate repeated injections, and preserve vision and quality of life. By addressing multiple unmet needs through novel mechanisms and delivery technologies, Oculis directly supports the global fight against preventable blindness.
Policy Significance
Oculis’ pipeline progress aligns with policy priorities in vision health and chronic disease management. The company’s innovations may inform future guidelines for neuroprotective drug development, especially in diseases with no approved treatments. Furthermore, its advancements in non-invasive ophthalmic formulations support public health strategies emphasizing accessibility, affordability, and patient adherence.
Oculis’ presence at AAO 2025 marks a pivotal moment in ophthalmic innovation. By progressing three late-stage programs — Privosegtor, OCS-01, and Licaminlimab — the company continues to lead in neuroprotection, ocular drug delivery, and precision eye care. With regulatory momentum and clinical readiness, Oculis is poised to redefine the treatment landscape for sight-threatening eye diseases.
Source: Oculis press release
