The Company is planning to conduct an end-of-Phase 2 meeting with the
FDA to discuss the registrational path for licaminlimab in DED and finalize the Phase 3 development plan.
Analyst and investor call
The Oculis management team will host an analyst and investor call today at 8:30 am US Eastern Time, to review the trial results.
Interested parties may participate in the call via the following webcast here.
A replay of the webcast and accompanying slides will be available for 90 days following the event through the Events and Presentations page
of the Investors and Media section of the companys website.
About Dry Eye Disease (DED)
DED is a common condition estimated to impact nearly 40 million people in 2023 in the US alone1. It
is a multifactorial disease in which ocular surface inflammation plays a central role in sustaining the pathological state2,3. It usually affects both eyes and patients may experience a stinging,
burning or scratchy sensation. In addition, some patients 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.
Of the approximately 20 million patients who are diagnosed with DED in the U.S., about half or 10 million are considered to have
moderate to severe disease1. However, only 13% receive prescription treatment, primarily with an anti-inflammatory medications1. Despite
currently available treatments, with 87% of chronic patients still unsatisfied4 highlighting the tremendous unmet need remaining in this underserved patient population. Furthermore, given the
heterogenicity of the DED patient population, there is a need for more personalized treatment approaches to improve outcomes for patients.
About
licaminlimab (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-necrotic 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. In multiple Phase 2 trials, licaminlimab has shown positive effects on treating both the signs and symptoms of DED and has been well tolerated. In addition, a genetic biomarker was identified which showed a clear
correlation between this variant in the TNFR1 gene and improved response to licaminlimab.
Licaminlimab is an investigational drug and has not received
regulatory approval for commercial use in any country. For more information, please visit: www.oculis.com
-ENDS-
About Oculis
Oculis is a global biopharmaceutical
company (Nasdaq: OCS; XICE: OCS) purposefully driven to save sight and improve eye care. Oculis highly differentiated pipeline comprises multiple innovative product candidates in development. It includes
OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; licaminlimab (OCS-02), a
topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05,
a neuroprotective candidate for acute optic neuritis (AON). Headquartered in Switzerland and with operations in the U.S. and Iceland, Oculis goal is to improve the health and quality of life of patients worldwide. The company is led by an
experienced management team with a successful track record and is supported by leading international healthcare investors.