Uveitis

OCS-02 (licaminlimab), an anti-TNFα eye drop candidate specifically designed to treat ocular inflammation, has the potential to address the unmet medical need in anterior uveitis for novel anti-inflammatory therapies

Uveitis is an inflammation of eye tissues that can lead to vision loss

Uveitis is a term describing a group of inflammatory diseases that produces swelling and destroys eye tissue which can lead to severe vision loss. Uveitis often affects a part of the eye called the uvea. It can also manifest itself in other areas of the eye, such as the lens, retina, optic nerve, and the vitreous.

PREVALENCE
121/
100K

Non-infectious uveitis affects approximately 121 per 100,000 people1.

It primarily affects people between the age of 20 and 60. Anterior uveitis is the most prevalent type accounting for 81% of uveitis patients1, and about half of the cases are either recurring or chronic.

Unmet medical need remains in anterior uveitis especially for novel anti-inflammatory therapies

There is a clear medical need for novel anti-inflammatory therapies for anterior uveitis, particularly for patients who require longer-term anti-inflammatory treatment. About 50% of patients who suffer from chronic or recurring uveitis are not optimally treated due to the associated side effect profiles of currently available treatments2.
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OCS-02

a novel TNFα inhibitor licaminlimab eye drop formulation has the potential to address the unmet medical needs in anterior uveitis for novel anti-inflammatory treatments.

OCS-02 (licaminlimab) is an anti-TNFα eye drop candidate developed with a single chain antibody fragment (scFv) technology specifically designed to treat ocular inflammatory diseases.

The dual anti-inflammatory and anti-apoptotic mechanism of action of TNF-α inhibition has been well established in inflammatory disorders where the systemic use of TNF-α inhibitors has led to marked improvements in the disease management and treatment outcomes.

Systemic TNFα inhibitors have been widely and effectively used to treat various inflammatory diseases such as arthritis, psoriasis or Crohn’s disease, with five FDA approved treatments. While a systemic treatment option is available for non-infectious intermediate, posterior and pan-uveitis, none are approved for non-infectious anterior uveitis which represents 85-90% of the uveitis cases.

OCS-02 (licaminlimab) has shown positive data in a Phase 2 proof-of-concept (PoC) trial in acute anterior uveitis, where it demonstrated a 56% responder rate at Day 15 with no significant ocular and non-ocular safety findings.

A topical anti-TNFα eye drop offers significant hope for the management of anterior uveitis and other inflammatory eye diseases. If approved, OCS-02 (licaminlimab) has the potential to become the first topical anti-TNFα for the treatment of non-infectious anterior uveitis, helping to address the significant medical need for novel anti-inflammatory treatments particularly for patients suffering from chronic or recurring disease who require longer-term treatment.

OCS-02 is an investigational drug and has not received regulatory approval for commercial use in any country.

Explore OCS-02 Clinical Trials in Dry Eye Disease

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COMPLETED

Phase 2: Proof of Concept Study to Evaluate Safety and Efficacy of OCS-02 (LME636) in the Treatment of Acute Anterior Uveitis

CLINICALTRIALS.GOV

Rethinking Ophthalmology to Save Sight and Improve Eye Care

The positive Phase 2a clinical trial results of OCS-02 (licaminlimab) in acute anterior uveitis demonstrated the potential of licaminlimab as a topical anti-TNFα therapy for anterior uveitis. These results have been crucial to inform further clinical trials for OCS-02 (licaminlimab) as a steroid-sparing treatment for patients with recurring or chronic anterior uveitis, where its unique profile may offer the greatest benefit to patients.”

Anat Galor, M.D.
Professor of Ophthalmology at the University of Miami Health System

Rethinking Ophthalmology