Oculis Holding AG is a global biopharmaceutical company, which engages in sight and improving eye care. The firm's pipeline includes multiple product candidates in development such as, OCS-01, a topical retinal candidate for diabetic macular edema, OCS-02, a topical biologic candidate for dry eye disease, and OCS-05, a disease modifying candidate for acute optic neuritis and other neuro-ophtha disorders such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. The company was founded in 2016 and is headquartered in Zug, Switzerland.
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- The U.S. FDA has granted breakthrough therapy designation to Oculis' neuroprotective candidate Privosegtor for treating optic neuritis, a rare condition that can lead to permanent vision loss. - In the Phase 2 ACUITY trial, patients receiving Privosegtor 3 mg/kg/day plus IV methylprednisolone gained an average of 18 letters on visual acuity tests at three months compared to placebo. - Privosegtor represents the potential first neuroprotective therapy for optic neuropathies, addressing a market opportunity potentially exceeding $7 billion in the U.S. alone. - The company has launched the PIONEER program with three pivotal trials to support registration plans for Privosegtor in optic neuritis and NAION, with PIONEER-1 initiated in Q4 2025.
- Oculis appointed Mark Kupersmith, M.D., as Chief Medical Advisor for Neuro-Ophthalmology following positive Phase 2 ACUITY trial results with Privosegtor (OCS-05) in acute optic neuritis. - Sebastian Wolf, M.D., Ph.D., was named Chief Medical Advisor for Ophthalmology as the company advances its Phase 3 DIAMOND trials of OCS-01 eye drops in diabetic macular edema. - The appointments strengthen Oculis' scientific leadership as the company progresses toward potential regulatory filings, with topline results from Phase 3 trials expected in Q2 2026. - Both advisors bring decades of clinical expertise, with Kupersmith having 40 years in neuro-ophthalmology and Wolf authoring over 400 peer-reviewed publications in retinal diseases.
• Oculis has successfully enrolled over 800 patients across 119 global sites in its DIAMOND Phase 3 trials evaluating OCS-01, the first-ever topical eye drop treatment for diabetic macular edema. • The DIAMOND program represents a potential paradigm shift in DME treatment, offering a non-invasive alternative to current therapies that require intravitreal injections or ocular implants. • Topline data from both Phase 3 trials is expected in Q2 2026, with NDA submission to follow, potentially addressing the needs of millions of patients with this leading cause of vision loss in diabetics.
- Oculis announced the expansion of Privosegtor (OCS-05) development beyond acute optic neuritis to include non-arteritic anterior ischemic optic neuritis (NAION) and acute relapses in multiple sclerosis patients. - The company has completed enrollment of over 800 patients in two Phase 3 DIAMOND trials for OCS-01 eye drops in diabetic macular edema, with topline data anticipated in Q2 2026. - Licaminlimab (OCS-02), a topical anti-TNFα biologic, is advancing with a genotype-based personalized approach for dry eye disease, with Phase 2/3 studies expected to begin in the second half of 2025.
• Oculis' OCS-05 demonstrates significant neuroprotective effects in acute optic neuritis patients, showing preserved retinal ganglion cells and reduced multiple sclerosis relapses in Phase 2 ACUITY trial. • The company's lead candidate OCS-01, utilizing OPTIREACH® technology, progresses in Phase 3 trials for diabetic macular edema, offering potential non-invasive alternative to intravitreal injections. • Oculis develops OCS-02, a TNF inhibitor with biomarker-driven approach for dry eye disease, representing a shift toward precision medicine in ophthalmic treatment.
• Oculis Holding AG's OCS-05 met the primary safety endpoint and achieved statistically significant results in key secondary efficacy endpoints in the ACUITY trial. • The Phase 2 trial evaluated OCS-05 in patients with acute optic neuritis, demonstrating a favorable safety profile compared to placebo. • Treatment with OCS-05 resulted in significant improvements in retinal structure and visual function, suggesting neuroprotective benefits. • The FDA has cleared the IND application for OCS-05, enabling clinical development in the U.S. as part of a global program.
• Oculis reports significant progress in its product pipeline, notably in the OCS-01 Phase 3 DIAMOND program for diabetic macular edema (DME) and the OCS-05 Phase 2 ACUITY trial for acute optic neuritis (AON). • The company anticipates topline results from the OCS-05 Phase 2 ACUITY trial in AON in December 2024, which will provide insights into the safety, tolerability, and neuroprotective potential of OCS-05. • Oculis's leadership team has been strengthened with key appointments, and the company's cash reserves of $125.0 million are expected to fund operations into the second half of 2026. • The company plans to be NDA submission ready in Q1 2025 for OCS-01 for post-operative pain and inflammation, following a pre-NDA meeting with the FDA in August 2024.
• Oculis reports significant progress in its product pipeline, notably in the Phase 3 DIAMOND program for DME with OCS-01 and the Phase 2 ACUITY trial for AON with OCS-05. • The company anticipates topline results from the OCS-05 Phase 2 ACUITY trial in acute optic neuritis in December 2024, offering insights into its neuroprotective potential. • Oculis is preparing for an NDA submission for OCS-01 in post-operative pain and inflammation by Q1 2025, following a pre-NDA meeting with the FDA. • With a strong cash position of $125.0 million, Oculis expects to fund operations into the second half of 2026, supporting its clinical development programs.
• Oculis reports significant progress in its product pipeline, including enrollment in the OCS-01 DIAMOND Phase 3 program for diabetic macular edema (DME). • The company anticipates topline results from the OCS-05 Phase 2 ACUITY trial in acute optic neuritis (AON) in December 2024. • Oculis' cash, cash equivalents, and short-term investments totaled $125.0 million as of September 30, 2024, funding operations into the second half of 2026.
- Oculis Holding AG reports accelerated enrollment in its DIAMOND Phase 3 trials for OCS-01 eye drops to treat diabetic macular edema (DME). - The DIAMOND-1 trial has enrolled approximately 70% of patients, while the DIAMOND-2 trial has reached about 40% enrollment. - Oculis has expanded its DIAMOND program committees, adding globally recognized retina experts to provide strategic oversight. - OCS-01, if approved, could become the first topical eye drop for DME, potentially transforming the current treatment approach.
