爱尔康已收购Aurion Biotech多数股权，以推进角膜内皮疾病创新细胞疗法的发展-动脉网

Alcon Acquires Majority Interest in Aurion Biotech, Inc. to Advance Innovative Cell Therapy for Corneal Endothelial Disease

爱尔康等信源发布 2025-03-26 16:30

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Leverages Alcon’s global scale with Aurion’s cell therapy expertise to accelerate U.S. Phase 3 development in fall of 2025

利用爱尔康的全球规模和Aurion的细胞治疗专业知识，加速2025年秋季美国三期临床开发。

Aurion’s lead asset received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. Food and Drug Administration (FDA)

Aurion公司的主要资产获得了美国食品药品监督管理局（FDA）的突破性疗法认定和再生医学先进疗法认定。

Positions Alcon at the leading edge of biopharma applications in ophthalmology with the potential to advance the first-ever corneal cell therapy candidate

将爱尔康定位在眼科生物制药应用的前沿，有望推动首个角膜细胞疗法候选方案的发展。

GENEVA--(BUSINESS WIRE)--

日内瓦--(BUSINESS WIRE)--

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced it has acquired a majority interest in Aurion

爱尔康（SIX/NYSE: ALC），全球眼科护理领域的领导者，致力于帮助人们获得清晰视力，今天宣布已收购Aurion的多数股权。

Biotech, Inc., a clinical-stage company developing advanced cell therapies to treat eye diseases.

生物技术公司，一家开发先进细胞疗法以治疗眼科疾病的临床阶段公司。

Aurion will operate as a separate company with full support from Alcon to advance its clinical-stage allogeneic cell therapy asset, AURN001, into Phase 3 for corneal edema secondary to corneal endothelial disease during the second half of 2025. Aurion will have access to the broader R&D, regulatory, medical ophthalmic and commercial capabilities of Alcon.

Aurion 将作为一家独立公司运营，并获得 Alcon 的全力支持，以在 2025 年下半年将其临床阶段的同种异体细胞治疗药物 AURN001 推进至第 3 期，用于治疗因角膜内皮疾病引起的角膜水肿。Aurion 将可以利用 Alcon 更广泛的研发、监管、眼科医学及商业能力。

In conjunction with this transaction, the Aurion Board has appointed Arnaud Lacoste, PhD, formerly Chief Scientific Officer, to the role of CEO of Aurion effective immediately..

与此交易相关，Aurion董事会已任命前首席科学官Arnaud Lacoste博士为Aurion的首席执行官，立即生效。

“Alcon is dedicated to developing and delivering innovative treatments for global unmet needs in eye care, including vision-threatening corneal endothelial disease, which affects millions of people worldwide,” said David Endicott, CEO of Alcon. “Dr. Lacoste and the Aurion team have done tremendous work and their technology is a natural fit as we continue to expand our ophthalmic pharmaceutical portfolio.

“Alcon致力于开发和提供满足全球眼科未满足需求的创新疗法，包括威胁视力的角膜内皮疾病，这种疾病影响着全球数百万人，”Alcon首席执行官David Endicott表示。“Lacoste博士和Aurion团队做出了巨大的贡献，他们的技术与我们不断扩展的眼科药物组合非常契合。”

We recognize the exciting potential of cell therapies in ophthalmology, particularly given the shortage of available corneal tissue globally, and look forward to assisting Aurion in this promising area of patient care.”.

我们认识到细胞疗法在眼科领域的激动人心的潜力，尤其是在全球可用角膜组织短缺的情况下，并期待协助Aurion在这一充满希望的患者护理领域。

Aurion has received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. Food and Drug Administration (FDA) for AURN001, a novel cell therapy for the treatment of corneal edema secondary to corneal endothelial disease. AURN001 is a combination cell therapy product candidate comprised of allogeneic human corneal endothelial cells (.

Aurion公司已获得美国食品药品监督管理局（FDA）授予的AURN001的突破性疗法认定和再生医学先进疗法认定，这是一种用于治疗因角膜内皮疾病引起的角膜水肿的新型细胞疗法。AURN001是一种组合细胞疗法候选产品，由同种异体人角膜内皮细胞组成。

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在依赖中

) and a rho kinase inhibitor (Y-27632). This investigational product has not been approved by the FDA.

) 和 rho 激酶抑制剂 (Y-27632)。该研究性产品尚未获得 FDA 批准。

“As the global leader in eye care, Alcon will help Aurion optimize the development of AURN001,” said Dr. Lacoste. “Since Aurion’s formation in 2022, we’ve achieved significant clinical, regulatory and CMC milestones to bring this much-needed therapy to patients, because we know there is a chronic global shortage of corneal tissue.

“作为眼科护理的全球领导者，爱尔康将帮助Aurion优化AURN001的开发，”拉科斯特博士说。“自Aurion于2022年成立以来，我们在临床、监管和CMC方面取得了重要的里程碑，以将这种急需的疗法带给患者，因为我们知道全球角膜组织长期短缺。”

With our manufacturing innovations, we can expand cells from a single donor to produce up to 1,000 doses. We look forward to leveraging Alcon’s global resources and commercial expertise as we initiate our U.S. Phase 3 trials later this year.”.

通过我们的制造创新，我们可以从单个供体扩增细胞，生产多达1000剂。我们期待在今年晚些时候启动美国三期临床试验时，利用爱尔康的全球资源和商业专长。

Aurion has completed enrollment and dosing of a prospective, multi-center, randomized, double-masked, parallel-arm dose-ranging, Phase 1/2 clinical study of AURN001 (the CLARA trial). Ninety-seven subjects with corneal edema secondary to corneal endothelial dysfunction were randomized into five dosing arms at sites in the U.S.

Aurion 已完成 AURN001（CLARA 试验）的前瞻性、多中心、随机、双盲、平行臂剂量范围探索的 1/2 期临床研究的入组和给药。美国各地的研究中心将 97 名因角膜内皮功能障碍导致角膜水肿的受试者随机分配到五个剂量组。

and Canada. The results of this study support the advancement of AURN001 into Phase 3 development..

并支持将AURN001推进到第三阶段开发。

In September 2024, Aurion announced the first global commercial launch of this technology, Vyznova™ (which includes

2024年9月，Aurion宣布了这项技术的全球首次商业发布，Vyznova™（其中包括

neltependocel

), in Japan for the treatment of bullous keratopathy of the cornea. Bullous keratopathy is a sight-threatening and debilitating condition affecting the endothelial cells of the cornea causing accumulation of fluid in the form of blisters on the cornea, which can cause severe pain..

），在日本用于治疗角膜大泡性角膜病变。大泡性角膜病变是一种威胁视力并使人衰弱的疾病，影响角膜的内皮细胞，导致液体以水泡形式在角膜上积聚，可能引起剧烈疼痛。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警示性声明

This document contains, and our officers and representatives may from time to time make, certain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as “anticipate,” “intend,” “commitment,” “look forward,” “maintain,” “plan,” “goal,” “seek,” “target,” “assume,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods.

本文件包含，并且我们的高级职员和代表可能不时做出一些符合美国1995年私人证券诉讼改革法案安全港条款定义的“前瞻性陈述”。前瞻性陈述可以通过诸如“预期”、“意图”、“承诺”、“期待”、“维持”、“计划”、“目标”、“寻求”、“瞄准”、“假设”、“相信”、“预计”、“估算”、“展望”、“未来”、“可能”、“应该”、“将”等词汇以及类似指向未来期间的表述加以识别。

Examples of forward-looking statements include, among others, statements we make regarding our liquidity, revenue, gross margin, operating margin, effective tax rate, foreign currency exchange movements, earnings per share, our plans and decisions relating to various capital expenditures, capital allocation priorities and other discretionary items such as our market growth assumptions, our social impact and sustainability plans, targets, goals and expectations, and generally, our expectations concerning our future performance..

前瞻性陈述的例子包括但不限于：我们关于流动性、收入、毛利率、营业利润率、有效税率、外汇汇率变动、每股收益的陈述，我们关于各种资本支出、资本配置优先事项及其他酌情项目的计划和决策，如市场增长假设、社会影响和可持续发展计划、目标、预期，以及通常关于我们未来业绩的预期。

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict such as: cybersecurity breaches or other disruptions of our information technology systems; our ability to effectively manage the risks associated with the ethical use of disruptive technologies; compliance with data privacy, identity protection and information security laws, particularly with the increased use of artificial intelligence; the impact of a disruption in our global supply chain, including the effect of tariffs, or important facilities, particularly when we single-source or rely on limited sources of supply; our ability to manage social impact and sustainability matters; our reliance on outsourcing key business functions; global and regional economic, financial, monetary, legal, tax, political and social change; the increasingly challenging economic, political and legal environment in China; terrorism, war and other resulting events such as economic sanctions and trade restrictions; our ability to manage the risks associated with operating as a third party contract manufacturer; our ability to forecast sales demand and manage our inventory levels and the changing buying patterns of our customers; our success in completing and integrating strategic acquisitions, including equity investments in early-stage companies; the success of our research and development efforts, including our ability to innovate to compete effectively; our ability to comply with th.

前瞻性声明既不是历史事实，也不是对未来业绩的保证。相反，它们仅基于我们当前对未来业务、未来计划和战略以及其他未来状况的信念、预期和假设。由于前瞻性声明涉及未来，它们受制于固有的不确定性和难以预测的风险，例如：网络安全漏洞或我们信息技术系统的其他中断；我们有效管理与颠覆性技术的道德使用相关风险的能力；遵守数据隐私、身份保护和信息安全法律，特别是随着人工智能使用的增加；全球供应链中断的影响，包括关税或重要设施的影响，特别是当我们单一采购或依赖有限的供应来源时；我们管理社会影响和可持续发展问题的能力；我们对外包关键业务职能的依赖；全球和地区经济、金融、货币、法律、税务、政治和社会变化；中国日益严峻的经济、政治和法律环境；恐怖主义、战争及其他由此产生的事件，如经济制裁和贸易限制；我们作为第三方合同制造商运营相关风险管理的能力；我们预测销售需求、管理库存水平以及客户购买模式变化的能力；我们成功完成并整合战略性收购的能力，包括对早期公司的股权投资；我们研发工作的成功，包括我们创新以有效竞争的能力；我们遵守法律法规的能力。

Additional factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated.

其他因素在我们向美国证券交易委员会提交的文件中有所讨论，包括我们的20-F表格。如果这些不确定性或风险中的一个或多个成为现实，或者如果基本假设被证明是错误的，实际结果可能会与预期有重大差异。

Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this document speak only as of the date of its filing, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise..

因此，您不应依赖任何这些前瞻性陈述。本文件中的前瞻性陈述仅在其提交日期时有效，我们不承担因新信息、未来事件或其他原因而更新前瞻性陈述的义务。

About Alcon

关于爱尔康

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors.

爱尔康帮助人们实现卓越的视觉。作为拥有75年以上历史的眼科护理全球领导者，我们提供最广泛的产品组合来增强视力并改善人们的生活。我们的外科和视力保健产品每年惠及140多个国家中超过2.6亿受白内障、青光眼、视网膜疾病和屈光不正等问题困扰的人们。

Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at .

我们超过25,000名员工通过创新的产品、与眼科护理专业人士的合作以及推动获取优质眼科护理的项目，提升人们的生活质量。欲了解更多信息，请访问。

www.alcon.com

。

About Aurion Biotech, Inc.

关于极光生物技术公司

Aurion Biotech’s mission is to restore vision to millions of patients with life-changing regenerative therapies. It received the prestigious Prix Galien award for best start-up in biotech in 2022. Aurion Biotech is advancing AURN001, an investigational single administration, allogeneic cell therapy to treat corneal edema secondary to corneal endothelial dysfunction.

Aurion Biotech 的使命是通过改变生命的再生疗法为数百万患者恢复视力。该公司于2022年荣获享有盛誉的加利恩奖最佳生物技术初创公司奖。Aurion Biotech 正在推进 AURN001，这是一种研究性的单次给药、同种异体细胞疗法，用于治疗因角膜内皮功能障碍引起的角膜水肿。

Aurion Biotech developed and has launched the first commercially available corneal endothelial cell therapy in Japan. To learn more, visit .

Aurion Biotech开发并推出了日本首个商业化的角膜内皮细胞疗法。欲了解更多信息，请访问。

www.aurionbiotech.com

。

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