ZUG, Switzerland, June 10, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced positive topline results from its Phase 2b RELIEF trial with licaminlimab, a novel anti-TNFα biologic eye drop with an established dual anti-inflammatory and anti-apoptotic mechanism of action in patients with dry eye disease (DED)..

瑞士祖格，2024年6月10日（环球通讯社）--Oculis Holding AG（纳斯达克：OCS）（“Oculis”）是一家旨在挽救视力和改善眼部护理的全球生物制药公司，今天宣布其使用利卡米利马（一种新型抗TNFα生物滴眼液）进行的2b期缓解试验的阳性结果，该滴眼液在干眼症（DED）患者中具有既定的双重抗炎和抗凋亡作用机制。。

The Phase 2b RELIEF trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the efficacy and safety of licaminlimab in subjects with signs of DED (NCT05896670). The trial also evaluated the efficacy and safety of licaminlimab in a subpopulation of subjects with a TNFR1-related genotype as prespecified in the protocol.

2b期缓解试验是一项多中心，随机，双盲，媒介物对照试验，评估利卡明单抗在有DED症状的受试者中的疗效和安全性（NCT05896670）。该试验还评估了licaminlimab在方案中预先指定的具有TNFR1相关基因型的受试者亚群中的有效性和安全性。

One hundred and twenty-two (122) patients were randomized 1:1 to either licaminlimab (n=62) or vehicle (n=60) across 4 sites for a 6-week treatment period and a 2-week follow up. A total of 23 patients carried a specific TNFR1-related genotype. Patients were evaluated for efficacy endpoints at baseline, Day 15 and Day 43.

一百二十二（122）名患者以1:1的比例随机分配到4个部位的利卡明单抗（n=62）或载体（n=60），为期6周的治疗期和2周的随访。共有23名患者携带特定的TNFR1相关基因型。在基线，第15天和第43天评估患者的疗效终点。

The prespecified investigational efficacy measures in this trial included multiple signs of DED that are accepted by the FDA as efficacy endpoints..

该试验中预先指定的研究疗效指标包括DED的多种迹象，这些迹象被FDA接受为疗效终点。。

Phase 2b RELIEF trial showed positive effects on multiple signs of DED

2b期缓解试验显示对DED的多种体征有积极影响

For the full trial population (n=122):

对于全部试验人群（n=122）：

Treatment effect favoring licaminlimab was observed in multiple sign endpoints including fluorescein staining in the total cornea, inferior corneal,

在多个体征终点观察到有利于licaminlimab的治疗效果，包括总角膜，下角膜，

central corneal and nasal conjunctival regions, and in the Schirmer’s test.

中央角膜和鼻结膜区域，以及Schirmer测试。

For the subpopulation of patients with the TNFR1 genetic biomarker (n=23):

对于具有TNFR1遗传生物标志物的患者亚群（n=23）：

Treatment effect favoring licaminlimab was observed in multiple sign endpoints including fluorescein staining in the total cornea, inferior corneal, central corneal, nasal conjunctival, total conjunctival and total ocular surface regions, in the Schirmer’s test, and in conjunctival redness.

在Schirmer试验和结膜发红的多个体征终点观察到有利于利卡米利马的治疗效果，包括总角膜，下角膜，中央角膜，鼻结膜，总结膜和总眼表区域的荧光素染色。

Rapid and favorable treatment effect in favor of licaminlimab on corneal inflammation was observed as early as Day 15 that was significant at Day 43, as measured by the difference in mean change from baseline versus vehicle for inferior corneal fluorescein staining score: -0.59 (CI: -1.165, -0.017).

早在第15天就观察到有利于利卡明单抗对角膜炎症的快速和有利的治疗效果，这在第43天是显着的，通过从基线与载体的平均变化的差异来测量角膜荧光素染色评分：-0.59（CI：-1.165，-0.017）。

The treatment effect also increased over time. See Figure below:.

治疗效果也随着时间的推移而增加。参见下图：。

Licaminlimab was well tolerated. The incidence of ocular TEAEs in the study eye was 11.5% in the licaminlimab group and 10.2% in the vehicle group. TEAEs in the fellow eye were similar to the study eye. All ocular TEAEs were mild and transient, and there were no serious ocular adverse events observed with licaminlimab in the study.

利卡米利马耐受性良好。研究眼中TEAE的发生率在licaminlimab组为11.5%，在载体组为10.2%。对侧眼中的TEAE与研究眼相似。所有眼部TEAE均为轻度和短暂性，并且在研究中没有观察到利卡米利马的严重眼部不良事件。

Drop comfort was also evaluated and was similar to artificial tears..

还评估了跌落舒适度，类似于人工泪液。。

Riad Sherif, M.D., Chief Executive Officer of Oculis, commented: “We are pleased that we achieved all of our objectives for the trial, and extremely encouraged to see licaminlimab’s profound results with a precision medicine approach which has the potential to transform the way we develop drugs and treat patients in ophthalmology.

Oculis首席执行官Riad Sherif医学博士评论道：“我们很高兴我们实现了试验的所有目标，并极为鼓舞地看到利卡米利马通过精准医学方法取得了深远的成果，这有可能改变我们在眼科开发药物和治疗患者的方式。

With this and prior positive results on signs and symptoms, we look forward to discussing these encouraging data with the FDA and advancing this program into Phase 3.”.

有了这一点以及之前对体征和症状的积极结果，我们期待着与FDA讨论这些令人鼓舞的数据，并将该计划推进到第三阶段。”。

Eric Donnenfeld, M.D., Clinical Professor of Ophthalmology at New York University and Chair of Oculis’ Cornea Scientific Advisory Board, added: “The precision medicine approach with licaminlimab could be a groundbreaking paradigm shift in ophthalmology and the treatment of DED. The current approach of ‘trial and error’ and our inability to predict response for this highly heterogenous population leads to a low level of patient satisfaction.

纽约大学眼科临床教授、Oculis角膜科学咨询委员会主席Eric Donnenfeld医学博士补充道：“利卡米利马的精准医学方法可能是眼科学和DED治疗的突破性范式转变。目前的‘试错’方法以及我们无法预测对这种高度异质人群的反应，导致患者满意度低。

To my knowledge, Licaminlimab is the first dry eye disease medication to demonstrate in a clinical trial a predictive treatment effect in patients with a common genetic biomarker to potentially solve this problem.”.

据我所知，Licaminlimab是第一种在临床试验中证明对具有常见遗传生物标志物的患者具有预测性治疗效果的干眼病药物，可以潜在地解决这个问题。”。

Christophe Baudouin, M.D., Ph.D., Professor of Ophthalmology and Chairman of Ophthalmology III at Quinze-vingts National Ophthalmology Hospital, Paris, and member of Oculis Scientific Advisory Board, added: “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.”.

克里斯托弗·博杜因（ChristopheBaudouin），医学博士，眼科教授，巴黎Quinze-vingts国家眼科医院眼科III主席，Oculis科学咨询委员会成员，补充道：“我很高兴看到利卡米利马具有双重抗炎和抗凋亡作用机制，靶向DED的起源，并有可能真正改善疾病，如DED的几种临床症状（包括角膜染色）的改善所示。”。

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.

该公司计划与FDA举行第二阶段会议，讨论利卡米利马在DED的注册路径，并最终确定第三阶段的发展计划。

Analyst and investor call

分析师和投资者电话

The Oculis management team will host an analyst and investor call today at 8:30 am US Eastern Time, to review the trial results.

Oculis管理团队将于美国东部时间今天上午8:30主持分析师和投资者电话会议，以审查试验结果。

Interested parties may participate in the call via the following webcast here.

感兴趣的各方可以通过以下网络广播参与此次通话。

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 company’s website.

在活动结束后的90天内，将通过公司网站“投资者和媒体”部分的“活动和演示”页面提供网络广播和随附幻灯片的重播。

About Dry Eye Disease (DED)

关于干眼病（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.

DED是一种常见病，估计2023年仅在美国就将影响近4000万人1。它是一种多因素疾病，其中眼表炎症在维持病理状态中起着核心作用2,3。它通常会影响眼睛，患者可能会感到刺痛，灼热或刺痛。

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..

此外，一些患者对光线敏感，眼睛发红，戴隐形眼镜困难，夜间驾驶困难以及视力模糊，这些都会极大地影响他们的生活质量。。

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.

在美国约2000万被诊断患有DED的患者中，约有一半或1000万被认为患有中度至重度疾病1。然而，只有13%接受处方治疗，主要是抗炎药物1。尽管目前有可用的治疗方法，但仍有87%的慢性病患者不满意4，这突出表明在这个服务不足的患者群体中仍然存在巨大的未满足需求。

Furthermore, given the heterogenicity of the DED patient population, there is a need for more personalized treatment approaches to improve outcomes for patients..

此外，鉴于DED患者人群的异质性，需要更个性化的治疗方法来改善患者的预后。。

About licaminlimab (OCS-02)

关于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.

Licaminlimab是一种抗TNFα滴眼剂候选药物，采用单链抗体片段（scFv）技术开发，专门用于治疗眼部炎症性疾病。TNF-α抑制的双重抗炎和抗坏死作用机制已在炎症性疾病中得到确立，其中TNF-α抑制剂的全身使用已导致疾病管理和治疗结果的显着改善。

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..

在多项2期临床试验中，利卡米利马对治疗DED的体征和症状均显示出积极作用，并且耐受性良好。此外，鉴定出一种遗传生物标志物，该标志物显示TNFR1基因中的这种变异与对利卡米利马的反应改善之间存在明显的相关性。。

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

利卡米利马是一种研究药物，尚未在任何国家获得商业用途的监管批准。有关更多信息，请访问：www.oculis.com

About Oculis

Empty关于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).

Oculis是一家全球性生物制药公司（Nasdaq:OCS；XICE:OCS），旨在挽救视力和改善眼部护理。Oculis高度分化的产品线包括多个正在开发的创新产品候选产品。它包括OCS-01，一种用于糖尿病性黄斑水肿（DME）和白内障手术后炎症和疼痛治疗的局部滴眼剂候选药物；licaminlimab（OCS-02），一种局部生物抗TNFα滴眼液，用于干眼症（DED）和非感染性前葡萄膜炎；和OCS-05，一种急性视神经炎（AON）的神经保护候选物。

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..

Oculis总部位于瑞士，在美国和冰岛开展业务，其目标是改善全球患者的健康和生活质量。该公司由经验丰富的管理团队领导，拥有成功的业绩记录，并得到领先的国际医疗保健投资者的支持。。