Dry Eye Disease
Licaminlimab, an anti-TNFα eye drop candidate specifically designed to treat ocular inflammation, has the potential to transform the treatment paradigm of dry eye disease (DED). Licaminlimab is the first DED candidate with a genotype-based development to drive a precision medicine approach.
Dry eye disease is a multifactorial disease with a dissatisfied and heterogenous patient population1
Dry eye disease (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 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.
Unmet medical needs remain for novel anti-inflammatory treatments which are efficacious, fast-acting and well-tolerated as well as developing targeted therapeutics for specific patient subtypes to improve treatment outcomes for this heterogeneous patient population7.
Licaminlimab
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. It is the first product candidate in ophthalmology with genotype-based development to drive a precision medicine approach.
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, 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, 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 Licaminlimab. In this trial, Licaminlimab showed a 7-fold increase in the treatment response to improve ocular discomfort in patients with the TNFR1 genetic biomarker.
In 2024, 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.
In the RELIEF trial, the most frequently reported (>2%) ocular treatment-emergent adverse events (TEAEs) were all reported as mild and transient and included:
- Instillation site irritation: 5 (8.2%) with licaminlimab versus 1 (1.7%) with vehicle
- Instillation site pruritus: 2 (3.3%) with licaminlimab versus 0 (zero) with vehicle
No TEAE related to burning or blurred vision were reported, similar to the previous symptoms study.
A precision medicine approach with a simple biomarker to help predict which patients will experience a more pronounced treatment response to 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, 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.
Licaminlimab is an investigational drug and its safety or efficacy has not been established and it 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, 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, 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 Licaminlimab. In this trial, Licaminlimab showed a 7-fold increase in the treatment response to improve ocular discomfort in patients with the TNFR1 genetic biomarker.
In 2024, 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.
In the RELIEF trial, the most frequently reported (>2%) ocular treatment-emergent adverse events (TEAEs) were all reported as mild and transient and included:
- Instillation site irritation: 5 (8.2%) with licaminlimab versus 1 (1.7%) with vehicle
- Instillation site pruritus: 2 (3.3%) with licaminlimab versus 0 (zero) with vehicle
No TEAE related to burning or blurred vision were reported, similar to the previous symptoms study.
A precision medicine approach with a simple biomarker to help predict which patients will experience a more pronounced treatment response to 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, 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.
Licaminlimab is an investigational drug and its safety or efficacy has not been established and it has not received regulatory approval for commercial use in any country.
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I am very excited to see that Licaminlimab, with its dual anti-inflammatory and anti-apoptotic mechanism of action, targets the origin of DED and has the potential to be truly disease modifying as shown by improvements in several clinical signs of DED, including corneal staining.”