Selagine, Inc. (UIC), announced today that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for immunoglobulin (IG) drops (GRF312 Ophthalmic Solution) for the treatment of patients with dry eye disease (DED). An IG eye drop is an anti-inflammatory and immunomodulatory biologic drug that is generated from pooled human plasma from thousands of healthy donors.

Selagine, Inc. (UIC) 今天宣布，美国食品和药物管理局 (FDA) 已批准用于治疗干眼病 (DED) 患者的免疫球蛋白 (IG) 滴眼液 (GRF312 眼用溶液) 的新药临床试验 (IND)。IG 滴眼液是一种抗炎和免疫调节生物药物，由来自数千名健康捐赠者的混合人血浆制备而成。

In a first-in-human pilot clinical trial conducted at the .

在一项首次人体试验中。

University of Illinois

伊利诺伊大学

College of Medicine (UI COM), Department of Ophthalmology & Visual Sciences, immunoglobulin eye drops caused a significant reduction in signs and symptoms of dry eyes with no difference in tolerability or adverse events.

医学院（UI COM），眼科与视觉科学系，免疫球蛋白滴眼液显著减少了干眼症的症状和体征，且在耐受性或不良事件方面没有差异。

Immunoglobulin Eye Drop

免疫球蛋白滴眼液

In

在

March 2023

2023年3月

, Selagine announced a research, development, and sublicense agreement with Grifols, the sponsor of the IND and a global leader in plasma-derived medicines, for the development and commercialization of immunoglobulin eye drops for DED. Initial developmental work for the IG eye drops was performed in the Department of Ophthalmology & Visual Sciences at the UIC College of Medicine and .

，Selagine宣布与Grifols达成研发和分许可协议，Grifols是该IND的赞助商，也是血浆衍生药物的全球领导者，共同开发和商业化用于DED的免疫球蛋白滴眼液。IG滴眼液的初步开发工作是在UIC医学院眼科与视觉科学系完成的。

Loyola University

Loyola大学

, supported by UI Health Pharmacy, and is the outcome of over a decade of research and development efforts, with grant funding from the National Eye Institute (NEI)/National Institutes of Health (NEI R24EY032440), Research to Prevent Blindness and UIC's Office of Technology Management. The Selagine-Grifols sublicense agreement has since been expanded to include the treatment of chemical traumatic injuries with IG eye drops..

，得到了UI Health Pharmacy的支持，是十多年来研发努力的成果，获得了国家眼科研究所（NEI）/国家卫生研究院（NEI R24EY032440）、防盲研究基金会以及UIC技术管理办公室的资助。Selagine-Grifols的分许可协议已经扩展到包括使用IG滴眼液治疗化学创伤性损伤。

Inflammatory proteins (cytokines or chemokines), cells (neutrophils, T-cells, and dendritic cells), complement system components, and pathogenic antibodies are present on the ocular surface in chronic dry eye disease; therefore, several different mechanisms of inflammation are simultaneously active and contribute to symptoms and signs of dry eye disease.

在慢性干眼病的患者眼部表面存在炎症蛋白（细胞因子或趋化因子）、细胞（中性粒细胞、T细胞和树突状细胞）、补体系统成分以及致病性抗体；因此，多种不同的炎症机制同时活跃，并导致干眼病的症状和体征。

IG eye drops have beneficial actions on each of these mechanisms, thus providing broad-spectrum anti-inflammatory actions and potentially providing mechanistic superiority over currently approved therapies for chronic dry eye disease. The anti-inflammatory actions of eye drops that are currently approved for treating chronic dry eye disease are narrow-spectrum and limited primarily to targeting T-cell inflammatory mechanisms..

IG滴眼液对上述每种机制都有益处，因此提供了广谱的抗炎作用，并可能在机制上优于目前批准的用于治疗慢性干眼病的疗法。目前批准用于治疗慢性干眼病的滴眼液的抗炎作用是窄谱的，主要局限于针对T细胞炎症机制。

'The IND clearance opens the door to clinical trials for establishing the safety and efficacy of IG eye drops and brings us one step closer to meaningfully improving outcomes for people suffering from dry eyes' says

“IND许可为进行临床试验以验证IG滴眼液的安全性和有效性打开了大门，使我们更进一步地帮助干眼症患者显著改善治疗效果。”

Sandeep Jain

桑迪普·贾恩

, MD, Professor of Ophthalmology & Visual Sciences at UIC and Founder and President of Selagine, Inc. 'With its strategic commitment to ophthalmics and its global leadership in immunoglobulins, we believe Grifols provides an ideal partner for realizing Selagine's goal of developing the full potential of plasma protein-based eye drops across all ophthalmic indications.'.

医学博士，伊利诺伊大学芝加哥分校眼科与视觉科学教授，Selagine公司创始人兼总裁。“凭借其在眼科领域的战略承诺及在免疫球蛋白方面的全球领导地位，我们相信Grifols是实现Selagine开发基于血浆蛋白的眼药水在所有眼科适应症中潜力的理想合作伙伴。”

'Selagine's success at moving the IG product forward with strong industrial and government partnerships is a testament to UIC's commitment to conducting translational research with multiple applications to benefit patients and providers.' Says Suseelan Pookote, PhD, Senior Director of UIC's Office of Technology Management.

“Selagine在通过强大的工业和政府合作推动IG产品发展方面的成功，证明了UIC致力于开展具有多种应用的转化研究，以造福患者和供应商。” UIC技术管理办公室高级主任Suseelan Pookote博士说道。

'With this IND clearance, Selagine's IG product adds to UIC's strong clinical pipeline with eight products in Phase II clinical trials advancing towards the market.'.

“随着这项IND审批通过，Selagine的IG产品为UIC强大的临床管线增添了力量，目前已有八种产品进入II期临床试验，正迈向市场。”

'We believe our immunoglobulin eye drops have the potential to make a qualitative leap in how dry eye disease is treated,' said Dr. Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer. 'Research suggests that the broad-spectrum anti-inflammatory and immunomodulatory properties of an ocular surface IG are superior to currently approved therapies, including artificial tears and anti-inflammatories.

“我们相信我们的免疫球蛋白滴眼液有潜力在干眼病的治疗方面实现质的飞跃，”Grifols首席科学创新官Jörg Schüttrumpf博士说道。“研究表明，眼部表面免疫球蛋白的广谱抗炎和免疫调节特性优于目前获批的疗法，包括人工泪液和抗炎药物。”

We are using our extensive and deep knowledge of immunoglobulins to benefit the millions of patients globally who aren't receiving sufficient relief'..

我们正在利用我们对免疫球蛋白的广泛而深入的知识，来造福全球数百万未能获得足够缓解的患者。

About Dry Eye Disease

关于干眼症

Dry eye happens when the eyes do not make enough tears to stay wet, or when the tears do not work correctly. This can make the eyes feel uncomfortable, and in some cases it can also cause vision problems. Dry eye affects millions of Americans every year, especially older Americans and women. Autoimmune conditions, such as Sjogren's syndrome, rheumatoid arthritis, Stevens-Johnson syndrome and ocular graft-versus-host-disease are associated with a more severe form of dry eyes.

当眼睛没有产生足够的泪液以保持湿润，或者泪液无法正常发挥作用时，就会发生干眼症。这可能会让眼睛感到不适，并且在某些情况下还会导致视力问题。干眼症每年影响数百万美国人，尤其是年长者和女性。自身免疫性疾病，如干燥综合症、类风湿性关节炎、史蒂文斯-约翰逊综合症以及眼部移植物抗宿主病等，与更严重的干眼症状有关。

As many as one-third of patients visiting ophthalmology clinics report dry eye symptoms, making it one of the most common conditions seen by ophthalmology specialists. Dry eye disease is the 3rd largest indication of the overall ophthalmology market. The global dry eye market size is projected to reach more than .

多达三分之一的患者在眼科诊所就诊时报告干眼症状，这使其成为眼科专家最常见的病症之一。干眼病是整个眼科市场的第三大适应症。预计全球干眼市场将超过。

USD 6.5 billion

65亿美元

by 2027.

到2027年。

For more information about dry eye see:

有关干眼症的更多信息，请参见：

https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye

https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye

About Selagine

关于Selagine

Selagine Inc. is a clinical-stage spin-out company from the

Selagine Inc. 是一家临床阶段的分拆公司，出自

University of Illinois Chicago

伊利诺伊大学芝加哥分校

(UIC) that is commercializing technology which was developed within the

（UIC）正在将该技术商业化，这项技术是在内部开发的。

University of Illinois

伊利诺伊大学

College of Medicine (UI COM), Department of Ophthalmology & Visual Sciences. UI COM places a strong emphasis on supporting faculty efforts toward academic entrepreneurship through initiatives such as the COMassist entrepreneur-in-residence program led by Dr.

医学院（UI COM），眼科与视觉科学系。UI COM 通过诸如由 Dr. 领导的 COMassist 驻校企业家计划等举措，大力支持教职员工在学术创业方面的努力。

Michael Flavin

迈克尔·弗拉纳根

. Selagine is focused on developing novel therapeutics to help patients suffering from a variety of debilitating ocular diseases, and to improve the quality of life in conditions where effective therapies do not exist.

塞拉金致力于开发新型疗法，帮助那些饱受各种严重眼疾困扰的患者，并改善当前尚无有效治疗手段的疾病的生活质量。

Selagine's office is located within the Illinois Medical District and its R&D laboratory is housed in UIC's Incubator Laboratory Facility, a hub for entrepreneurship and innovation at the University.

塞拉金的办公室位于伊利诺伊医疗区内，其研发实验室则设在UIC的孵化器实验室设施中，这是该大学创业和创新的中心。

About Grifols

关于Grifols

Grifols is a global healthcare company founded in

Grifols 是一家全球医疗保健公司，成立于

Barcelona

巴塞罗那

in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces and provides innovative healthcare services and solutions in more than 110 countries.

1909年致力于改善世界各地人民的健康和福祉。作为血浆衍生药物和输血医学领域的领导者，该公司在110多个国家开发、生产和提供创新的医疗保健服务和解决方案。

Patient needs and Grifols' ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company's innovation in both plasma medicines and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across four main therapeutic areas: immunology, infectious diseases, pulmonology and critical care..

患者的需求以及Grifols对许多慢性、罕见和常见疾病（有时是危及生命的）的不断增长的知识，推动了公司在血浆药物和其他生物制药领域的创新，以提高生活质量。Grifols专注于治疗四个主要治疗领域的疾病：免疫学、传染病、肺病学和重症监护。