Licaminlimab

如果您是视网膜色素变性（RP）患者，可能会发现自己不仅要面对夜盲、视野缩窄等典型症状,还常常伴有眼睛干涩、异物感、灼热等不适。这并非巧合。 RP本身虽然不直接引起干眼症，但RP患者因为多重因素的叠加影响，比普通人更容易出现干眼问题： ① 神经调节改变 → 眼表泪液反射下降 RP 会影响视网膜神经信号的传递，进而影响泪腺分泌反馈机制，使泪液减少。 ② 眼表长期轻度炎症 → 泪膜质量下降 即使没有明显红肿，RP 患者的眼表也更容易处于“隐性炎症”状态，泪膜不稳定导致干眼加重。 ③ 用眼方式变化 → 眨眼减少 因为夜盲、周边视野受限，RP 患者看东西需要更费力，导致眨眼变少，加速泪液蒸发。 ④ 维 A 代谢异常 → 泪膜生成受影响 某些 RP 基因变异与视黄醇通路相关，也可能间接影响泪液健康。 好消息是：如果能及早处理，这类干眼往往可改善视觉质量、延长可用视野、减少眼疲劳，让“剩余视力更舒服”。 图片来源Oculis官网，若侵权请联系删除。 01 干眼症：一个被低估的 "视力杀手" 什么是干眼症？ 干眼症（DED）是一种常见的眼表疾病，全球患者超过1.1亿人。在美国，约有4000万人受到影响，其中1000万人被诊断为中度至重度干眼症。 它不仅仅是"眼睛有点干"那么简单。干眼症是一种多因素疾病，核心问题是眼表炎症持续存在，形成恶性循环： 泪液不足/质量差 → 眼表受损 → 炎症反应 → 泪液分泌进一步减少 → 症状加重 常见症状： 异物感、灼热感（像有沙子在眼睛里） 畏光、眼红 视力模糊、波动不定 难以佩戴隐形眼镜，夜间驾驶困难 对于RP患者而言，这些症状会进一步影响本已受损的视功能，降低生活质量。 图片来源网络，若侵权请联系删除。 02 突破性创新：利卡明利单抗（Licaminlimab） ——精准抗炎新希望 利卡明利单抗（Licaminlimab）是一种创新的抗TNF-α生物滴眼液，由瑞士公司Oculis开发，专门用于治疗眼部炎症性疾病，特别是干眼症。 它的特别之处在于：双重作用机制：既抗炎又抗细胞凋亡 抗炎作用：TNF-α是眼表炎症的关键"导火索"，利卡明利单抗能够精准中和TNF-α的活性，打断炎症恶性循环 抗细胞凋亡：保护眼表细胞免受损伤，促进眼表修复 为什么选择抗TNF-α？全身性TNF-α抑制剂（如用于治疗类风湿关节炎、银屑病的生物制剂）已经在临床使用多年，疗效卓越。利卡明利单抗将这一成熟机制引入眼科，开创了局部抗TNF-α治疗的先河。独特的抗体片段技术：更小、更强、渗透更好 传统抗体药物分子量大，难以穿透眼表组织。利卡明利单抗采用单链抗体片段（scFv）技术： 分子更小：比完整抗体小得多，易于配制高浓度制剂 渗透性更强：能够更有效地穿透角膜和结膜，直达病灶 局部给药安全性高：避免了全身用药的副作用风险精准医疗：基因生物标志物指导用药 这是利卡明利单抗最具革命性的突破！ 在临床试验中，研究人员发现了一种TNFR1基因相关的生物标志物： 携带该生物标志物的患者对利卡明利单抗的治疗反应显著增强（疗效提高7倍） 通过简单的基因检测，可以提前预测哪些患者更可能从治疗中获益 这意味着告别"试错法"，实现"对症下药"！ 图片来源Oculis官网，若侵权请联系删除。 03 临床试验结果：疗效显著、起效迅速、耐受性好 RELIEF 2b期试验亮点 2024年6月，Oculis公司公布了利卡明利单抗治疗干眼症的RELIEF 2b期临床试验结果，涉及122名患者：整体人群疗效 在多个干眼症体征指标上优于安慰剂，包括： 角膜荧光素染色（反映角膜损伤程度） 结膜充血 Schirmer试验（泪液分泌量） 基因生物标志物人群疗效更显著 在23名携带TNFR1基因生物标志物的患者中： 起效迅速：第15天即可观察到角膜炎症改善 疗效持续增强：第43天达到统计学显著差异（下角膜荧光素染色评分改善-0.59，95% CI：-1.165，-0.017） 多项指标全面改善（全角膜、下角膜、中央角膜、鼻侧结膜、全结膜、全眼表荧光素染色，以及结膜充血、泪液分泌） 安全性优异 耐受性与安慰剂相似 眼部不良反应发生率：利卡明利单抗组11.5% vs 安慰剂组10.2% 所有眼部不良反应均为轻度且短暂（如滴注时轻微刺激感） 滴眼舒适度与人工泪液相当 未发生严重眼部不良事件 总体眼部不适评分从基线到第 29 天的变化，来源于文献Topical Anti-TNFα Agent Licaminlimab (OCS-02) Relieves Persistent Ocular Discomfort in Severe Dry Eye Disease: A Randomized Phase II Study 04 对视网膜疾病患者意味着什么？ 利卡明利单抗的出现，对于RP等视网膜疾病患者具有特殊意义： 直击炎症根源： 针对RP患者干眼背后隐藏的眼表炎症，从源头打破“炎症-干眼-视力下降”的恶性循环。 迅速改善视觉质量： 干眼症状的快速缓解（2周内），能有效减少您的视力波动，提高剩余视力的利用效率，让阅读和用眼更舒适。 告别“试错”： 通过基因检测指导用药，避免漫长而无效的治疗，节省时间和金钱成本。 安全长期管理： 良好的安全性和舒适度使其适合作为RP患者长期管理干眼的选择。 图片来源网络，若侵权请联系删除。 05 利卡明利单抗的未来进展 目前，利卡明利单抗已完成2b期临床试验，Oculis公司计划： • 与美国FDA举行2期临床试验结束（EoP2）会议 • 最终确定3期临床试验开发计划 • 争取早日获批上市 注意：利卡明利单抗目前仍是研究性药物，尚未在任何国家或地区获得商业用途的监管批准。其安全性和有效性仍在评估中。 图片来源网络，若侵权请联系删除。 END RP 本身已经足够辛苦，不要让“干眼”悄悄地加剧您的视觉不适。 记住：干眼是可控的。 随着利卡明利单抗（Licaminlimab）这类精准抗炎滴眼液的研发进展，未来RP患者的眼表管理将更加高效、个体化。 如果您经常感觉眼睛干、涩、疲劳，请及时就医。正确管理干眼，能让您眼前的世界清晰好一些，舒服多一些！ 点击名片关注我们吧～ 如需转载请标明来源  扫码加入群聊，和我们一起交流吧～  温馨提示：本文数据来自截至 2025 年 11月18日的公开信息，具体上市时间和适用人群请以监管机构最终批准为准。我们会持续关注进展，第一时间带来更新！ 版权声明 本账号署名原创的内容，均为创作者个人学习梳理与心得总结，仅作为交流学习之用途，绝无剽窃、抄袭之主观意图。若内容涉及版权归属争议、标记错误或侵权嫌疑，敬请通过留言方式联系创作者，我方将在第一时间核实情况，并根据实际需求进行更正、下架或删除处理。 免责声明 本账号对转载、分享的第三方内容、观点陈述及判断，均保持客观中立立场，不偏向任何一方。不对所转载分享内容的准确性、完整性、可靠性及适用性作出任何明示或暗示的承诺与保证，相关内容仅为读者提供参考，不构成任何决策建议或行动依据。

Oculis accelerates its portfolio development with Privosegtor moving into the PIONEER pivotal program in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) following positive FDA meeting OCS-01 DIAMOND Phase 3 trials in diabetic macular edema (DME) remain on track for topline results expected in Q2 2026 Licaminlimab PREDICT-1 registrational trial, the first genotype-based trial to drive precision medicine in dry eye disease (DED), expected to start in Q4 2025 Cash, cash equivalents and short-term investments of $182.2 million as of September 30, 2025 plus recent $110 million financing, extend cash runway into 2029 ZUG, Switzerland, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced results for the third quarter ended September 30, 2025, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated: “Oculis has entered a pivotal stage in its transformation into a leader in ophthalmology and neuro-ophthalmology, powered by its differentiated and innovative portfolio. We are excited about several key developments: OCS-01 eye drops Phase 3 in DME with anticipated readout in Q2 2026, the initiation of a first in class registrational trial with Licaminlimab in precision medicine for DED, and, very importantly, we are thrilled with our positive discussions with the U.S. Food and Drug Administration (FDA), which paved the way to accelerate Privosegtor development in key unmet medical needs. Our recent financing now secures the resources needed for three pivotal trials in optic neuropathies, a potential market opportunity representing approximately $7 billion in the U.S. alone, with no available therapies. Supported by a strong balance sheet and a robust late-stage pipeline, we are well-positioned to achieve 6 pivotal readouts with the current funding, reinforcing our commitment to delivering groundbreaking treatments.” Recent Clinical Highlights and Upcoming Milestones: Privosegtor: Following a successful meeting with the FDA, Oculis announced the launch of the PIONEER program, which will include three pivotal trials to support registration plans for Privosegtor in AON and NAION (management webcast available here for replay): The first two trials, PIONEER-1 and PIONEER-2, will evaluate Privosegtor following the acute onset of optic neuritis in a broad population consisting of patients with multiple sclerosis (MS) and those without MS. Primary endpoint will be low-contrast visual acuity (LCVA) at 3 months. Dosing and patient enrollment criteria will mirror the positive Phase 2 ACUITY trial, which demonstrated improvement in visual function and anatomical preservation of the retina in patients with AON. PIONEER-1 is expected to initiate in Q4 2025, with PIONEER-2 planned to follow in the first half of 2026. The third trial in the PIONEER program, PIONEER-3, will evaluate Privosegtor after the acute onset of NAION. This study shares the core design and operational elements with PIONEER-1 and PIONEER-2 and is expected to initiate in mid-2026. Running the PIONEER trials concurrently is expected to generate operational synergies, cost efficiencies, and to speed up Privosegtor development timelines. Oculis will cross-reference the existing Privosegtor AON Investigational New Drug (IND) when submitting a new IND to the FDA for the acute treatment of relapses in multiple sclerosis (MS). Successful ACUITY Phase 2 trial results in patients with AON were presented in late-breaking abstract sessions at the European Society of Retina Specialists (EURETINA) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congresses. Following a successful meeting with the FDA, Oculis announced the launch of the PIONEER program, which will include three pivotal trials to support registration plans for Privosegtor in AON and NAION (management webcast available here for replay): The first two trials, PIONEER-1 and PIONEER-2, will evaluate Privosegtor following the acute onset of optic neuritis in a broad population consisting of patients with multiple sclerosis (MS) and those without MS. Primary endpoint will be low-contrast visual acuity (LCVA) at 3 months. Dosing and patient enrollment criteria will mirror the positive Phase 2 ACUITY trial, which demonstrated improvement in visual function and anatomical preservation of the retina in patients with AON. PIONEER-1 is expected to initiate in Q4 2025, with PIONEER-2 planned to follow in the first half of 2026. The third trial in the PIONEER program, PIONEER-3, will evaluate Privosegtor after the acute onset of NAION. This study shares the core design and operational elements with PIONEER-1 and PIONEER-2 and is expected to initiate in mid-2026. Running the PIONEER trials concurrently is expected to generate operational synergies, cost efficiencies, and to speed up Privosegtor development timelines. The first two trials, PIONEER-1 and PIONEER-2, will evaluate Privosegtor following the acute onset of optic neuritis in a broad population consisting of patients with multiple sclerosis (MS) and those without MS. Primary endpoint will be low-contrast visual acuity (LCVA) at 3 months. Dosing and patient enrollment criteria will mirror the positive Phase 2 ACUITY trial, which demonstrated improvement in visual function and anatomical preservation of the retina in patients with AON. PIONEER-1 is expected to initiate in Q4 2025, with PIONEER-2 planned to follow in the first half of 2026. The third trial in the PIONEER program, PIONEER-3, will evaluate Privosegtor after the acute onset of NAION. This study shares the core design and operational elements with PIONEER-1 and PIONEER-2 and is expected to initiate in mid-2026. Running the PIONEER trials concurrently is expected to generate operational synergies, cost efficiencies, and to speed up Privosegtor development timelines. Oculis will cross-reference the existing Privosegtor AON Investigational New Drug (IND) when submitting a new IND to the FDA for the acute treatment of relapses in multiple sclerosis (MS). Successful ACUITY Phase 2 trial results in patients with AON were presented in late-breaking abstract sessions at the European Society of Retina Specialists (EURETINA) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congresses. OCS-01: DIAMOND Phase 3 trials with OCS-01, aims to be the first eye drop for DME, are fully enrolled with over 800 patients across both trials. Topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with NDA submission to the FDA planned for 2H 2026. DME affects approximately 37 million people worldwide and represents a ~$5 billion market opportunity with high unmet medical needs for early intervention and for patients with inadequate response to standard of care. DIAMOND Phase 3 trials with OCS-01, aims to be the first eye drop for DME, are fully enrolled with over 800 patients across both trials. Topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with NDA submission to the FDA planned for 2H 2026. DME affects approximately 37 million people worldwide and represents a ~$5 billion market opportunity with high unmet medical needs for early intervention and for patients with inadequate response to standard of care. Licaminlimab: Aligned with the FDA on the genotype-based development plan to drive precision medicine in DED. Registrational trial expected to initiate in Q4 2025 following three positive Phase 2 studies previously completed, including the demonstration of profound effects on TNFR1-positive patients. Aligned with the FDA on the genotype-based development plan to drive precision medicine in DED. Registrational trial expected to initiate in Q4 2025 following three positive Phase 2 studies previously completed, including the demonstration of profound effects on TNFR1-positive patients. Q3 2025 Financial Highlights As of September 30, 2025, Oculis held cash, cash equivalents and short-term investments of CHF 145.2 million or $182.2 million. Following the October capital raise, the Company’s cash, cash equivalents and short-term investments was close to $300 million, before disbursing offering expenses. Research and development expenses were CHF 14.1 million or $17.6 million for the three months ended September 30, 2025, compared to CHF 13.0 million or $15.0 million in the same period in 2024. The increase was primarily due to increase in product development activities and associated personnel expenses. General and administrative expenses were CHF 6.4 million or $8.0 million for the three months ended September 30, 2025, compared to CHF 5.3 million or $6.2 million in the same period in 2024. The increase was primarily driven by share-based compensation expense and external professional services costs. Year-to-date net loss was CHF 75.4 million or $89.7 million for the nine months ended September 30, 2025, compared to CHF 57.1 million or $64.8 million for the same period in 2024. The increase was primarily driven by advancements in clinical development programs, in particular the Phase 3 DIAMOND trials, and a CHF 6.9 million or $8.2 million increase in the non-cash fair value adjustment on warrant liabilities as a result of appreciation of underlying warrant fair value. Condensed Consolidated Statements of Loss (Unaudited) About OculisOculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on innovations addressing neuro-ophthalmic conditions with significant unmet medical needs. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in Phase 2, which is being developed with a genotype-based approach to drive personalized medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis ContactMs. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com Media RelationsICR HealthcareAmber Fennell / David Daley / Sean Leousoculis@icrhealthcare.com Cautionary Statement Regarding Forward Looking StatementsThis press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy, including planned interactions with the FDA; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company’s expected financial position and cash runway, 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 U.S. Securities and Exchange Commission (SEC). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.