- Licaminlimab is a novel anti-TNFα biologic eye drop with an established dual mechanism of action, anti-inflammatory and anti-apoptotic, and a potential transformative impact on the treatment of inflammatory eye diseases
- RELIEF Phase 2b trial will evaluate the efficacy and safety of licaminlimab in moderate-to-severe Dry Eye Disease, and further explore the potential of a genetic biomarker
- Trial was initiated as planned with topline results expected in mid-2024
The Phase 2b RELIEF trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the safety and efficacy of licaminlimab for the treatment of signs and symptoms in moderate- to-severe DED. Furthermore, the trial will evaluate if patients with a specific genetic biomarker identified in a prior trial respond better to licaminlimab. The trial was designed after several trials with licaminlimab in DED and Uveitis demonstrated positive findings. 120 patients are planned to be randomized to either licaminlimab or vehicle for a 6-week treatment and a 2-week follow up period. Topline results are anticipated in mid-2024.
About Dry Eye Disease
DED is a common condition estimated to impact nearly 40 million people in 2023 in the US alone1. It is known as 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
About Oculis
Oculis is a global biopharmaceutical company (Nasdaq: 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 retinal candidate for diabetic macular edema (DME); OCS-02, a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED); and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. Headquartered in
For more information, please visit: www.oculis.com
Oculis Contacts
Ms.
sylvia.cheung@oculis.com
Investor & Media Relations
cdavis@lifesciadvisors.com
1-212-915-2577
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements and information. For example, statements regarding the potential of licaminlimab or OCS-02 in the treatment of inflammatory eye diseases or DED, the potential of a genetic biomarker; expected future milestones and catalysts; the initiation, timing, progress and results of Oculis’ clinical trials; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; and Oculis’ ability to advance product candidates into, and successfully complete, clinical trials, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the
1 DRG (part of Clarivate) – Dry Eye Disease Landscape and Forecast report 2020
2 TFOS DEWS II The Ocular Surface 15 (2017)
3 Baudouin C. Dry Eye Disease, the complex interactions of vicious cycles.
https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles
4 Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops
Source:
2023 GlobeNewswire, Inc., source