Oculis announces first patient first visit in Phase 2b RELIEF Trial of Topical Anti-TNFα licaminlimab in dry eye disease

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Oculis Holding AG announced the first patient first visit (FPFV) in its Phase 2b RELIEF trial evaluating the potential of licaminlimab (OCS-02), the company’s anti-TNFα biologic eye drop, for the treatment of dry eye disease (DED).

According to a news release,¹ 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.

Moreover, according to the company, 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-2024.¹

Riad Sherif, MD, CEO of Oculis, said the company was pleased to have achieved First Patient First Visit (FPFV) in the RELIEF trial as planned.

“The initiation of this trial represents a key milestone as we advance the development of OCS-02, a promising, differentiated candidate in Dry Eye,” Sherif said in the news release.

The achievement, according to Sherif, builds on the company’s earlier successes this year with positive Phase 3 results from its other lead asset, OCS-01, in diabetic macular edema and post-ocular surgery.

“DED remains an area of unmet medical need with only 13% of patients achieving lasting relief after 12 months of treatment in a large and growing market affecting approximately 40 million patients in the US,” he added. “We are confident that licaminlimab, given its proven mechanism of action and its prior clinical trials results, will have transformative potential in DED. We look forward to sharing the topline results in mid-2024.”

Eric Donnenfeld, MD, clinical professor of ophthalmology at New York University and a co-chairman of the Oculis Scientific Advisory Board, said the therapeutic is showing promise.

“Licaminlimab is a promising topical candidate, which has already shown strong data in two prior trials with over 215 patients, where it demonstrated superiority over vehicle in alleviating ocular discomfort in patients with severe DED while also being well tolerated,” he said in the news release. “Another unique finding from a prior Phase 2a trial was the discovery of a genetic biomarker that may help identify high responders to licaminlimab, which we look forward to exploring in the RELIEF trial.”

Christophe Baudouin, MD, PhD, professor of ophthalmology and chairman of Ophthalmology III at Quinze-vingts National Ophthalmology Hospital, Paris, and member of Oculis Scientific Advisory Board, pointed out in the news release that patients with DED, especially in its severe form, experience considerable impact on their quality of life due to the significant pain and discomfort it causes, among other signs and symptoms.

“Unfortunately, currently available treatments only provide lasting relief for a small portion of the patient population, and as a result, new treatment approaches are needed,” Baudouin said in the news release. “Licaminlimab leverages the already proven mechanism of action (MOA) of anti-TNFα which could be very beneficial given the central role of ocular surface inflammation in DED.

Baudouin added that it has been demonstrated that tears from DED patients contain increased concentrations of inflammatory cytokines, such as TNFα, that are correlated to disease severity.

“I believe that the anti-inflammatory and anti-apoptotic effects of blocking TNFα could potentially revolutionize the treatment of several inflammatory eye conditions, similarly to what anti-TNFα treatments have shown in other therapeutic areas,” he concluded.

DED is estimated to impact nearly 40 million people in 2023 in the US alone.² It is known as a multifactorial disease in which ocular surface inflammation plays a central role in sustaining the pathological state.^3,4 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 US, about half, or 10 million are considered to have moderate to severe disease; however, only 9% receive prescription treatment, primarily with anti-inflammatory medications.² Despite currently available treatments, only 13% of chronic patients said that they experienced lasting relief⁵ 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.

References:

1. AG OH. Oculis Announces First Patient First Visit in Phase 2b RELIEF Trial of Topical Anti-TNFα Licaminlimab (OCS-02) in Dry Eye Disease. GlobeNewswire News Room. Published December 7, 2023. Accessed December 7, 2023. https://www.globenewswire.com/news-release/2023/12/07/2792357/0/en/Oculis-Announces-First-Patient-First-Visit-in-Phase-2b-RELIEF-Trial-of-Topical-Anti-TNF

2. DRG (part of Clarivate) – Dry Eye Disease Landscape and Forecast report 2020

3. TFOS DEWS II The Ocular Surface 15 (2017) 
   Baudouin C. Dry Eye Disease, the complex interactions of vicious cycles.

4. EuDES European Dry Eye Society
    https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles

5. Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops