SEATTLE & CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)--Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced the commercial launch of Vyznova® (generic name: neltependocel) in Japan, for the treatment of bullous keratopathy of the cornea.

西雅图、剑桥、马萨诸塞州和东京——（商业新闻短讯）——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，今天宣布在日本商业推出Vyznova®（通用名：neltependocel），用于治疗角膜大疱性角膜病。

The Company believes this is the first approved cell therapy for the treatment of corneal endothelial disease; it has received both regulatory and reimbursement approval in Japan. The commercial launch was inaugurated with cell therapy procedures performed by Professor Shigeru Kinoshita, M.D., Ph.D., at Kyoto Prefecture University of Medicine (KPUM) in Kyoto, Japan.

该公司认为这是第一个被批准用于治疗角膜内皮疾病的细胞疗法；它已在日本获得监管和报销批准。日本京都府立医科大学（KPUM）医学博士Shigeru Kinoshita教授通过细胞治疗程序启动了商业启动。

Professor Kinoshita pioneered the research and development of corneal endothelial cell therapy, and the proprietary process for propagating corneal endothelial cells in vitro. Several years ago, Aurion Biotech acquired the technology from Kinoshita and KPUM, and the Company has continued to innovate by scaling the manufacture of fully differentiated, allogeneic human corneal endothelial cells, the active moiety of Vyznova®..

Kinoshita教授开创了角膜内皮细胞疗法的研究和开发，以及在体外繁殖角膜内皮细胞的专有过程。几年前，Aurion Biotech从Kinoshita和KPUM获得了这项技术，该公司通过扩大完全分化的同种异体人角膜内皮细胞（Vyznova®的活性部分）的生产规模，继续进行创新。。

“The benefits of over 25 years of our research are now a reality for patients. I am so grateful for the incredible contributions of my colleagues, my mentors, and Kyoto Prefecture University of Medicine for our shared hard work to achieve this milestone,” said Professor Kinoshita. “Most importantly, many thanks to my patients for helping me to understand their needs and for trusting us to develop this breakthrough regenerative medicine.”.

Kinoshita教授说：“我们超过25年的研究成果对患者来说已经成为现实。我非常感谢我的同事、导师和京都府立医科大学为实现这一里程碑所做出的巨大贡献。”。“最重要的是，非常感谢我的患者帮助我了解他们的需求，并信任我们开发这种突破性的再生医学。”。

Bullous keratopathy is a sight-threatening and debilitating condition affecting the endothelial cells of the cornea. Bullous keratopathy causes the accumulation of water in the form of blisters on the cornea, which can cause severe pain. When the endothelial cells malfunction or die, they are gone for good, since they do not replicate in vivo.

大疱性角膜病是一种威胁视力和使人衰弱的疾病，会影响角膜内皮细胞。大疱性角膜病导致角膜上水泡形式的水积聚，这可能导致严重的疼痛。当内皮细胞发生故障或死亡时，它们就会永远消失，因为它们不会在体内复制。

The subsequent clouding impairs the transparency of the cornea, and as the condition progresses, vision deteriorates. Patients may experience blurred vision, glares and halos when staring at bright lights, difficulty with night driving, and overall discomfort. If left untreated, patients’ symptoms will inevitably worsen over time and may eventually lead to blindness..

随后的混浊会损害角膜的透明度，随着病情的进展，视力会下降。当患者凝视明亮的灯光时，可能会出现视力模糊，眩光和光晕，夜间驾驶困难以及整体不适。如果不及时治疗，患者的症状将不可避免地随着时间的推移而恶化，最终可能导致失明。。

“Our commercial launch in Japan is exciting for patients around the world who suffer from corneal endothelial diseases,” said Greg Kunst, chief executive officer of Aurion Biotech. “After having received regulatory and reimbursement approval earlier this year in Japan, we intend to work closely with corneal specialists here, to adopt and disseminate their best practices for treating patients with this debilitating disease.”.

Aurion Biotech首席执行官格雷格·昆斯特（GregKunst）表示：“我们在日本的商业推出对于世界各地患有角膜内皮疾病的患者来说是令人兴奋的。”。“在今年早些时候获得日本监管和报销批准后，我们打算与这里的角膜专家密切合作，采用并传播他们治疗这种衰弱性疾病患者的最佳实践。”。

Until now, bullous keratopathy has been treated by corneal transplantation using donor corneal tissue. However, the supply of donor corneas has been chronically insufficient. A survey estimates that globally, for every 70 diseased eyes, there is only one donor cornea available for transplant1. Lack of corneal tissue in Japan has been a significant challenge in the treatment of bullous keratopathy.

。然而，供体角膜的供应长期不足。一项调查估计，在全球范围内，每70只患病眼睛中只有一只供体角膜可用于移植1。日本缺乏角膜组织一直是大疱性角膜病治疗的重大挑战。

By contrast, Aurion Biotech has developed a manufacturing process that can produce up to 1,000 doses from the corneal endothelial cells of a single donor..

相比之下，Aurion Biotech开发了一种制造工艺，可以从单个供体的角膜内皮细胞中产生多达1000剂。。

“The launch of Vyznova is the culmination of hard work and support from many sources, including early investments in regenerative medicines from the Japanese government2,” said Michael Hasegawa, senior managing director for Aurion Biotech Japan. “We are grateful for Professor Kinoshita’s inspiring leadership and ongoing collaboration with Aurion Biotech, and we thank our CDMO partner, S-RACMO, for producing our drug product to exacting standards.

Aurion Biotech Japan高级董事总经理迈克尔·长谷川（MichaelHasegawa）表示：“Vyznova的推出是来自许多方面的辛勤工作和支持的结晶，包括日本政府对再生医学的早期投资2。”。“我们感谢Kinoshita教授鼓舞人心的领导以及与Aurion Biotech的持续合作，并感谢我们的CDMO合作伙伴s-RACMO按照严格的标准生产我们的药品。

We look forward to bringing this treatment to patients who need a safe, effective and minimally invasive procedure to treat their disease.”.

我们期待着将这种治疗方法带给需要安全，有效和微创手术治疗疾病的患者。”。

This news comes on the heels of Aurion Biotech announcing that it has completed enrollment and dosing of 97 subjects in its Phase 1 / 2 trial in the U.S. and Canada. In addition, the U.S. Food and Drug Administration ('FDA') recently granted both Breakthrough Therapy designation and Regenerative Medicines Advanced Therapy designation to Aurion Biotech..

这一消息是在Aurion Biotech宣布其在美国和加拿大的1/2期试验中已完成97名受试者的登记和给药之后发布的。此外，美国食品和药物管理局（FDA）最近授予Aurion Biotech突破性治疗指定和再生药物高级治疗指定。。

About Aurion Biotech

关于Aurion Biotech

Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. In 2022, it received the prestigious Prix Galien award for best start-up in biotech. The Company believes its drug candidate is the first clinically validated cell therapy for corneal care, having received regulatory and reimbursement approval in Japan.

Aurion Biotech是一家临床阶段的生物技术公司，其使命是通过改变生命的再生疗法为数百万患者恢复视力。2022年，它获得了久负盛名的加利恩大奖赛生物技术最佳初创企业奖。该公司相信其候选药物是第一个经过临床验证的角膜护理细胞疗法，已在日本获得监管和报销批准。

The Company has received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. F.D.A. and has completed enrollment and dosing of 97 subjects in its Phase 1 / 2 clinical trial in the U.S. and Canada. Privately held, Aurion Biotech is backed by Deerfield, Alcon, Petrichor, Flying L Ventures, Falcon Vision / KKR, and Visionary Ventures.

该公司已获得美国食品药品管理局（U.S.F.D.A.）的突破性治疗指定和再生医学高级治疗指定，并已在美国和加拿大的1/2期临床试验中完成了97名受试者的登记和给药。Aurion Biotech是一家私营公司，由Deerfield、Alcon、Petrichor、Flying L Ventures、Falcon Vision/KKR和Visionary Ventures提供支持。