Dry Eye Disease
OCS-02 (licaminlimab), an anti-TNFα eye drop candidate specifically designed to treat ocular inflammation, has the potential transform the treatment paradigm of DED with a precision medicine strategy.
Dry Eye Disease (DED) is a multifactorial disease with a dissatisfied and heterogenous patient population1
DED is a multifactorial disease in which ocular surface inflammation plays a central role in sustaining the pathological state2. It usually affects both eyes and patients may experience a stinging, burning or scratchy sensation. Some patients also experience sensitivity to light, eye redness, difficulty wearing contact lenses, difficulty with nighttime driving, and blurred vision which can greatly affect their quality of life.
The DED patient population is heterogenous with various clinical features, often overlapping with one another. According to the DEWS II Management and Treatment report, the heterogeneity that exists in the DED patient population requires a tailored approach to DED management. With currently available treatment options, eye care practitioners often need to adapt their treatment strategies and rely on ‘trial and error’ to find the best approach for each patient.
Oculis is developing OCS-02 (licaminlimab), an innovative anti-TNFα eye drop candidate with dual mechanism of action, anti-inflammatory and anti-apoptosis, to help address some of the remaining unmet medical needs with a precision medicine approach.
People worldwide suffer from DED3.
The risk of developing DED increases with advancing age. Of the about 20 million patients diagnosed with DED in the U.S. alone, about 10 million are considered to have moderate to severe disease3,4.
Current treatments only provide lasting relief for a small portion of DED patients
Similarly, the American Academy of Ophthalmology mentioned that DED is often as a source of frustration for clinicians and patients alike5.
Lack of efficacy (45.1%) and adverse events (26.4%) are cited as the primary reasons for switching therapy and 90% of patients discontinued their treatment altogether within one year with the vast majority discontinuing in the first 6 months6.
OCS-02
is an anti-TNFα eye drop candidate developed with a single chain antibody fragment (scFv) technology specifically developed to treat ocular inflammatory diseases. It is designed to transform the treatment paradigm of DED with a precision medicine strategy.
The dual anti-inflammatory and anti-apoptotic mechanism of action (MoA) 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 used to treat various inflammatory diseases, such as arthritis, psoriasis or Crohn’s disease, with five FDA approved treatments.
As inflammation and apoptosis are directly linked to the pathogenesis of DED, OCS-02 (licaminlimab) has the potential to transform DED with this anti-TNFα dual MoA.
In two prior successful Phase 2 trials in symptoms of DED with over 215 patients, OCS-02 (licaminlimab)* has shown superiority over vehicle in alleviating ocular discomfort in patients while also being well tolerated. A pre-specified analysis in one of the Phase 2a trials in DED symptoms identified a TNFR1 genetic biomarker correlated to improved treatment response to OCS-02 (licaminlimab). In this trial, OCS-02 (licaminlimab) showed a 7-fold increase in the treatment response to improve ocular discomfort in patients with the TNFR1 genetic biomarker.
Most recently, Oculis announced the RELIEF Phase 2b trial results in which a treatment effect in favor of licaminlimab versus vehicle was observed on multiple signs of DED in the full trial population and consistent with the previous Phase 2 symptom trial, the treatment effects were more pronounced in the specific genotype population.
A precision medicine with a simple biomarker to help predict which patients will experience a more pronounced treatment response to OCS-02 (licaminlimab) could be groundbreaking for patients currently not well controlled with existing therapies.
Furthermore, the rapid onset in this subpopulation and high drop comfort level similar to artificial tears could alleviate some of the remaining unmet medical needs.
If approved, OCS-02 (licaminlimab) an anti-TNFα eye drop candidate specifically designed to treat ocular inflammation, has the potential to transform the treatment paradigm of DED with a precision medicine strategy.
OCS-02 is an investigational drug and has not received regulatory approval for commercial use in any country.
The dual anti-inflammatory and anti-apoptotic mechanism of action (MoA) 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 used to treat various inflammatory diseases, such as arthritis, psoriasis or Crohn’s disease, with five FDA approved treatments.
As inflammation and apoptosis are directly linked to the pathogenesis of DED, OCS-02 (licaminlimab) has the potential to transform DED with this anti-TNFα dual MoA.
In two prior successful Phase 2 trials in symptoms of DED with over 215 patients, OCS-02 (licaminlimab)* has shown superiority over vehicle in alleviating ocular discomfort in patients while also being well tolerated. A pre-specified analysis in one of the Phase 2a trials in DED symptoms identified a TNFR1 genetic biomarker correlated to improved treatment response to OCS-02 (licaminlimab). In this trial, OCS-02 (licaminlimab) showed a 7-fold increase in the treatment response to improve ocular discomfort in patients with the TNFR1 genetic biomarker.
Most recently, Oculis announced the RELIEF Phase 2b trial results in which a treatment effect in favor of licaminlimab versus vehicle was observed on multiple signs of DED in the full trial population and consistent with the previous Phase 2 symptom trial, the treatment effects were more pronounced in the specific genotype population.
A precision medicine with a simple biomarker to help predict which patients will experience a more pronounced treatment response to OCS-02 (licaminlimab) could be groundbreaking for patients currently not well controlled with existing therapies.
Furthermore, the rapid onset in this subpopulation and high drop comfort level similar to artificial tears could alleviate some of the remaining unmet medical needs.
If approved, OCS-02 (licaminlimab) an anti-TNFα eye drop candidate specifically designed to treat ocular inflammation, has the potential to transform the treatment paradigm of DED with a precision medicine strategy.
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
Phase 2: Safety and Efficacy of OCS-02 (Licaminlimab) Ophthalmic Suspension for the Treatment of Dry Eye Disease (RELIEF)
Phase 2: OCS-02 (LME636) in the Relief of Persistent Ocular Discomfort in Patients With Severe Dry Eye Disease
Discover Our Ophthalmic Treatment Candidates
Rethinking Ophthalmology to Save Sight and Improve Eye Care
With its anti-inflammatory and anti-necrotic dual mechanism of action, licaminlimab eye drops have shown promising results in previous trials including a significant reduction of ocular discomfort in DED, a rapid onset of action, and a good tolerability profile. Based on how the broader class of systemic TNFα inhibitors have dramatically improved the management of multiple inflammatory diseases in other therapeutic areas, I am eagerly awaiting the completion of the RELIEF trial to learn more about the potential of licaminlimab eye drops to address the unmet medical needs of the millions of patients living with DED.”