SEATTLE--(BUSINESS WIRE)--LumiThera Inc., a medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced the initiation of the largest PBM trial ever conducted in patients with dry age-related macular degeneration (AMD). A global registry data collection from patients treated with PBM using the Valeda® Light Delivery System (Valeda) has been established with Dendrite Clinical Systems LTD, a UK-based company specializing in registry studies.

西雅图-（商业新闻）-LumiThera Inc.，一家提供光生物调节（PBM）治疗眼部损伤和疾病的医疗器械公司，今天宣布启动有史以来最大规模的针对干性年龄相关性黄斑变性（AMD）患者的PBM试验。使用Valeda®Light Delivery System（Valeda）从接受PBM治疗的患者中收集的全球注册数据已与Dendrite Clinical Systems LTD建立，Dendrite Clinical Systems LTD是一家总部位于英国的专门从事注册研究的公司。

The multi-center clinical registry study will enroll 500-1,000 patients treated with PBM over the past three years. The study will initially include up to 20 European centers and could be expanded in other countries outside the Europe Union (EU) where Valeda is approved..

多中心临床登记研究将招募过去三年接受PBM治疗的500-1000名患者。该研究最初将包括多达20个欧洲中心，并可能在Valeda获得批准的欧盟（EU）以外的其他国家扩展。。

EUROLIGHT (European Union Registry Study) will collect safety and clinical efficacy outcomes such as best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) imaging data from multiple centers that have been treating dry AMD subjects in their practice. The large registry will collect data retrospectively with centers providing existing data from subjects who underwent PBM treatment every 4-6 months for up to three years.

EUROLIGHT（欧盟注册研究）将收集来自多个中心的安全性和临床疗效结果，例如最佳矫正视力（BCVA）和光学相干断层扫描（OCT）成像数据，这些中心一直在治疗干性AMD受试者。大型登记处将与提供现有数据的中心回顾性收集数据，这些数据来自每4-6个月接受PBM治疗长达三年的受试者。

Patients will continue to be followed prospectively. The data will be used to support reimbursement in multiple countries and provide important clinical information on real-world use of Valeda. The study has targeted select European centers with extensive expertise in the use of Valeda..

患者将继续接受前瞻性随访。这些数据将用于支持多个国家的报销，并提供有关Valeda实际使用的重要临床信息。这项研究针对的是在使用Valeda方面拥有广泛专业知识的选定欧洲中心。。

“The LIGHTSITE series of trials demonstrated improvements of visual benefits with PBM treatments in a prospective randomized clinical trial (RCT) design,” stated René Rückert, MD, MBA, Chief Medical Officer, LumiThera. “The RCT results demonstrated clinical benefits in early to intermediate patients out to two years with anatomical evidence of slowing of AMD disease progression.”.

LumiThera首席医学官、医学博士、MBA RenéRückert表示：“LIGHTSITE系列试验表明，在前瞻性随机临床试验（RCT）设计中，PBM治疗可改善视力。”。“随机对照试验结果显示，早期至中期患者在两年内具有临床益处，解剖学证据表明AMD疾病进展减慢。”。

The current registry collection will examine patients from early through late stage AMD disease and provide evidence of safety, clinical efficacy and biomarkers from imaging data. An estimated 16,000 patients in Europe and Latin America have been treated to date and represents a valuable dataset to garner further information about PBM treatment and AMD disease progression..

目前的登记收集将检查早期至晚期AMD疾病的患者，并从影像学数据中提供安全性，临床疗效和生物标志物的证据。迄今为止，欧洲和拉丁美洲估计有16000名患者接受了治疗，这是一个有价值的数据集，可以收集有关PBM治疗和AMD疾病进展的进一步信息。。

“We are very excited that the Duke Reading Center has been chosen as the independent image reading center to review data from real-world use of Valeda,” stated Glenn Jaffe, MD, Robert Machemer Professor of Ophthalmology, Duke University and Director of Duke Reading Center. “PBM treatment showed a statistically significant slowing of disease progression in patients with early to intermediate dry AMD for up to two years in the LIGHTSITE III study.

杜克大学眼科教授兼杜克阅读中心主任格伦·贾菲（GlennJaffe）医学博士、罗伯特·马切默（RobertMachemer）表示：“我们非常高兴杜克阅读中心被选为独立的图像阅读中心，以审查真实世界中使用Valeda的数据。”。“在LIGHTSITE III研究中，PBM治疗显示早期至中度干性AMD患者长达两年的疾病进展在统计学上显着减慢。

The global registry study will provide us with a unique dataset to evaluate disease biomarkers and disease progression, including drusen deposition and new geographic atrophy (GA) formation and lesion growth rates.”.

全球注册研究将为我们提供一个独特的数据集，以评估疾病生物标志物和疾病进展，包括玻璃疣沉积和新的地理萎缩（GA）形成和病变增长率。”。

“We are thrilled to be part of the EUROLIGHT study,” said Oygunn Uthiem, MD, PhD, Norwegian Dry Eye Clinic/Øyehelseklinikken, Department of Medical Biochemistry/Department of Ophthalmology, Oslo University Hospital. “We have treated over 350 patients in the last four years and have seen the real-world benefits of Valeda treatments in our patients.

奥斯陆大学医院医学生物化学系/眼科学系挪威干眼诊所/Øyehelseklinikken医学博士Oygunn Uthiem说：“我们很高兴成为EUROLIGHT研究的一部分。”。“在过去的四年中，我们已经治疗了350多名患者，并在我们的患者中看到了Valeda治疗的实际益处。

We have started to upload data into the registry database and have obtained over 70 informed consents from patients that want to be part of the study. Our patients have strictly followed the clinical trial protocols and been tested every 4-6 months, some for up to four years.”.

我们已经开始将数据上传到注册表数据库中，并从希望参与研究的患者那里获得了70多份知情同意书。我们的患者严格遵循临床试验方案，每4-6个月进行一次测试，有些长达四年。”。

“We have seen recent publications from the real-world setting that mirror our RCT trial results and we have several years of experience with Valeda treatments in the EU and LATAM,” stated Clark Tedford, Ph.D., President and CEO, LumiThera. “The ability to collect additional safety and efficacy data from our global experiences will help us continue to study the safety and effectiveness of PBM in early to late-stage disease treatment of dry AMD and its effect on the progression of disease and growth of GA lesion rates with detailed anatomical OCT analysis in several subsets of patients.”.

LumiThera总裁兼首席执行官Clark Tedford博士表示：“我们最近在现实世界中看到的出版物反映了我们的RCT试验结果，我们在欧盟和拉丁美洲拥有多年的Valeda治疗经验。”。“从我们的全球经验中收集额外安全性和有效性数据的能力将有助于我们继续研究PBM在干性AMD早期至晚期疾病治疗中的安全性和有效性，以及其对疾病进展和GA病变率增长的影响，并对几个亚组患者进行详细的解剖OCT分析。”。

About AMD

关于AMD

AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it harder to see faces, drive, read or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase seven-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years.

AMD是65岁及以上人群视力丧失的主要原因。失去中心视力会使人更难看清面孔、开车、阅读或做特写工作，如做饭或修理房子周围的东西。据估计，AMD的总体患病率随着年龄的增长而增加7倍，从45-49岁的4.2%增加到80-85岁的27.2%。

Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million)..

在全球范围内，2020年（1.956亿）至2030年（2.433亿）的患病率估计将增加20%。。

About Dendrite

关于枝晶

Dendrite Clinical Systems is a UK-headquartered international company with over a 25-year track record as a specialist provider of secure clinical registries, analysis software and consultancy services for the international healthcare sector, specifically for clinical research, multi-centre real-world studies, observational registries, international, national and hospital clinical databases..

Dendrite Clinical Systems是一家总部位于英国的国际公司，拥有超过25年的历史，是国际医疗保健领域安全临床注册、分析软件和咨询服务的专业提供商，专门为临床研究、多中心现实世界研究、观察性注册、国际、国家和医院临床数据库提供服务。。

Dendrite has been recognised as a leading provider of clinical registries across various specialties with a unique track record of implementing over 200 major clinical registry systems globally including systems for major research projects for medical device companies, CROs and pharmaceutical companies..

Dendrite已被公认为各专业临床注册的领先供应商，拥有在全球实施200多个主要临床注册系统的独特记录，包括医疗器械公司、CRO和制药公司的主要研究项目系统。。

About LumiThera

关于LumiThera

LumiThera, Inc. is a medical device company focused on diagnosing, treating, and monitoring ocular disease and damage including dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 65.

LumiThera，Inc.是一家医疗器械公司，专注于诊断，治疗和监测眼部疾病和损害，包括干性年龄相关性黄斑变性（AMD），这是65岁以上成年人失明的主要原因。

LumiThera’s flagship product, the Valeda® Light Delivery System, uses multiwavelength photobiomodulation to treat dry AMD patients. Valeda is CE Marked in the EU and is available in Europe and in countries in Latin America. Valeda is not yet approved by the Food & Drug Administration (FDA).

LumiThera的旗舰产品Valeda®光传输系统使用多波长光生物调节治疗干性AMD患者。Valeda在欧盟有CE标志，在欧洲和拉丁美洲国家均有销售。Valeda尚未获得食品和药物管理局（FDA）的批准。

AdaptDx Pro® dark adaptation functional testing technology enables eye care professionals to detect and monitor AMD three years before clinical presentation. AdaptDx Pro is listed on the FDA’s Establishment Registration & Device Listing.

AdaptedX Pro®暗适应功能测试技术使眼科护理专业人员能够在临床表现前三年检测和监测AMD。AdaptedX Pro被列入FDA的机构注册和设备清单。

Diopsys ERG and VEP systems help eye care professionals analyze the entire pathway for visual and neuro-visual disorders. VEP is FDA-cleared. ERG and VEP are available in select countries outside of the USA.

Diopsys ERG和VEP系统帮助眼科护理专业人员分析视觉和神经视觉障碍的整个途径。VEP已获得FDA批准。ERG和VEP可在美国以外的特定国家/地区获得。

LumiThera’s AMD Excellence Program® provides customer implementation, training, best practices, and ongoing support across all brands.

LumiThera的AMD卓越计划®为所有品牌的客户提供实施、培训、最佳实践和持续支持。

For more information on the Valeda® Light Delivery System please visit www.lumithera.com. The AdaptDx Pro and Diopsys ERG and VEP systems are available separately through LumiThera Diagnostics, Inc. and Diopsys, Inc.

有关Valeda®光传输系统的更多信息，请访问www.lumithera.com。AdaptedX Pro和Diopsys ERG和VEP系统可通过lumithera Diagnostics，Inc.和Diopsys，Inc.单独获得。