licaminlimab (OCS-02) / Novartis, Oculis - LARVOL DELTA

Oculis Hosts R&D Event Today to Showcase Progress on All Three Pipeline Assets (GlobeNewswire) - "The event will feature several world-renowned key opinion leaders (KOLs), and the presentations will cover: An update on the execution of the two Phase 3 DIAMOND trials of OCS-01 eye drops in diabetic macular edema (DME), with enrollment for both studies completed (>800 patients) and topline data anticipated in Q2 2026; The genotype-based development plan to drive a personalized approach in dry eye disease (DED) and Phase 2/3 study design for Licaminlimab (OCS-02) is anticipated to start in 2H 2025; An expanded data analysis from the ACUITY Phase 2 trial and future development plans for Privosegtor (OCS-05) in acute optic neuritis (AON). Two new programs will be announced utilizing Privosegtor as a neuroprotective treatment for an orphan condition, non-arteritic anterior ischemic optic neuritis (NAION), and for the acute treatment of relapses in multiple sclerosis (MS) patients."

Clinical data • Clinical protocol • Pipeline update • Diabetic Macular Edema • Dry Eye Disease • Multiple Sclerosis • Optic Neuritis

Licaminlimab in the treatment of dry eye disease (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Dry Eye Disease • Ophthalmology • TNFRSF1A

RELIEF: Safety and Efficacy of Licaminlimab Ophthalmic Solution for the Treatment of Dry Eye Disease (clinicaltrials.gov) - P2 | N=122 | Completed | Sponsor: Oculis | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Mar 2024

Trial completion • Trial completion date • Dry Eye Disease • Ophthalmology

Quintessence of currently approved and upcoming treatments for dry eye disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED...Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • ICAM1

Pharmacogenomic Analysis of Response to Topical Tumor Necrosis Factor α Antagonist Licaminlimab (OCS-02) in Dry Eye Disease: Retraction. (PubMed, Cornea) - No abstract available

Biomarker • Journal • Dry Eye Disease • Oncology • Ophthalmology

Oculis Announces Positive Topline Results of Phase 2b RELIEF Trial with Licaminlimab, Designed to Transform the Treatment Paradigm of Dry Eye Disease with a Precision Medicine Strategy (GlobeNewswire) - P2 | N=120 | RELIEF (NCT05896670) | Sponsor: Oculis | "Oculis Holding AG...announced positive topline results from its Phase 2b RELIEF trial with licaminlimab, a novel anti-TNFα biologic eye drop with an established dual anti-inflammatory and anti-apoptotic mechanism of action in patients with dry eye disease (DED)....Treatment effect favoring licaminlimab was observed in multiple sign endpoints including fluorescein staining in the total cornea, inferior corneal, central corneal and nasal conjunctival regions, and in the Schirmer’s test....Rapid and favorable treatment effect in favor of licaminlimab on corneal inflammation was observed as early as Day 15 that was significant at Day 43, as measured by the difference in mean change from baseline versus vehicle for inferior corneal fluorescein staining score: -0.59 (CI: -1.165, -0.017). The treatment effect also increased over time."

P2b data • Dry Eye Disease • Ophthalmology

Pharmacogenomic Analysis of Response to Topical Tumor Necrosis Factor α Antagonist Licaminlimab (OCS-02) in Dry Eye Disease. (PubMed, Cornea) - "The CC genotype of rs1800693, relatively common in patients with DED, was strongly associated with response to licaminlimab and decreased inflammatory cytokine gene expression in ocular surface cells during treatment. This study is one of the first to our knowledge to investigate pharmacogenomics in the treatment of DED."

Biomarker • Journal • Dry Eye Disease • Eye Cancer • Immunology • Ocular Inflammation • Ocular Melanoma • Oncology • Ophthalmology • Sjogren's Syndrome • CXCL8 • IL1B • TNFRSF1A

RELIEF: Safety and Efficacy of Licaminlimab Ophthalmic Suspension for the Treatment of Dry Eye Disease (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Oculis | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

RELIEF: Safety and Efficacy of Licaminlimab Ophthalmic Suspension for the Treatment of Dry Eye Disease (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Oculis | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

Safety and Efficacy of Licaminlimab Ophthalmic Suspension for the Treatment of Dry Eye Disease (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Oculis | Initiation date: Aug 2023 ➔ Dec 2023

Trial initiation date • Dry Eye Disease • Ophthalmology

Safety and Efficacy of Licaminlimab Ophthalmic Suspension for the Treatment of Signs and Symptoms of Dry Eye Disease (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Oculis

New P2 trial • Dry Eye Disease • Ophthalmology

Topical Anti-TNFα Agent Licaminlimab (OCS-02) Relieves Persistent Ocular Discomfort in Severe Dry Eye Disease: A Randomized Phase II Study. (PubMed, Clin Ophthalmol) - "Serum licaminlimab was undetectable in most patients; the maximum concentration observed was 8.47 ng/mL. Topical ocular licaminlimab demonstrated statistically significant improvement in global ocular discomfort score compared to Vehicle in patients with severe DED, with good tolerability, no increase in IOP, and minimal systemic drug exposure."

Clinical • P2 data • Diabetic Retinopathy • Dry Eye Disease • Oncology • Ophthalmology • Retinal Disorders