SEATTLE--(BUSINESS WIRE)--LumiThera Inc., a medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced the U.S. Food & Drug Administration (FDA) has authorized marketing of Valeda® Light Delivery System for treatment of patients with dry age-related macular degeneration (AMD), a leading cause of central vision loss in people over 55 in developed countries..

西雅图--（商业新闻短讯）--LumiThera Inc.是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，美国食品和药物管理局（FDA）已授权销售Valeda®光传递系统，用于治疗干性年龄相关性黄斑变性（AMD）患者，这是发达国家55岁以上人群中枢视力丧失的主要原因。。

The Valeda therapy is the first ever authorized treatment by the FDA for vision loss in dry AMD patients. Valeda provides an improvement in best corrected visual acuity (BCVA) over 24 months of >5 letters or equivalent to a line on the eye chart. In the pivotal U.S. LIGHTSITE III trial, the Valeda treatment met its primary endpoint and was shown to be safe and effective in increasing and maintaining improved visual acuity..

。Valeda在24个月内提高了最佳矫正视力（BCVA）>5个字母或相当于眼图上的一条线。在关键的美国LIGHTSITE III试验中，Valeda治疗达到了其主要终点，并被证明在提高和维持视力方面是安全有效的。。

LumiThera submitted the US LIGHTSITE III clinical data as part of a technical package to the FDA under a De Novo request with special controls.

LumiThera根据具有特殊控制的从头要求，将美国LIGHTSITE III临床数据作为技术包的一部分提交给FDA。

“The De Novo authorization established Valeda as the first device for treatment of dry AMD patients with vision loss and creates a threshold for this novel class of PBM devices that must show similar clinical and nonclinical performance controls equivalent to the Valeda Light Delivery System,” stated Lori Holder, Vice President, Regulatory Affairs, LumiThera, Inc..

LumiThera，Inc.监管事务副总裁Lori Holder表示：“从头授权将Valeda确立为治疗视力丧失的干性AMD患者的第一台设备，并为这类新型PBM设备设定了一个阈值，该设备必须显示与Valeda光传输系统类似的临床和非临床性能控制。”。。

“The RCT results demonstrated clinical benefits in early to intermediate dry AMD patients out to 24 months and an excellent safety profile,” stated David Boyer, MD, Retina Vitreous Associates Medical Group, Beverly Hills, CA. “Patients will now be able to try a non-invasive treatment that can help improve their vision earlier in the disease process.

加利福尼亚州贝弗利山视网膜玻璃体联合医疗集团医学博士DavidBoyer表示：“随机对照试验结果显示，早期至中期干性AMD患者在24个月内具有临床益处，并且具有良好的安全性。患者现在将能够尝试一种非侵入性治疗，可以帮助改善疾病早期的视力。

This is an exciting option for patients and something doctors and patients have been waiting for.”.

这对患者来说是一个令人兴奋的选择，也是医生和患者一直在等待的。”。

“The primary endpoint for the study was visual acuity gain,” indicated Glenn Jaffe, MD, Duke Reading Center. However, we also followed multiple anatomical endpoints from BL throughout the 24-month study to determine whether PBM helped to preserve retinal anatomy. The PBM treatment had a beneficial effect on multiple anatomic biomarkers.

杜克阅读中心医学博士格伦·贾菲（GlennJaffe）表示：“这项研究的主要终点是视力提高。”。。PBM治疗对多种解剖生物标志物具有有益作用。

For example, we looked at whether PBM affected progression to geographic atrophy and found that incident geographic atrophy was reduced in the PBM-treated eyes compared to the sham treated eyes respectively, 6.8% versus 24%. Although incident GA was not a prespecified clinical endpoint, the results supported overall safety benefits of treating earlier in dry AMD disease..

例如，我们研究了PBM是否影响地理萎缩的进展，发现与假手术治疗的眼睛相比，PBM治疗的眼睛发生的地理萎缩分别减少了6.8%和24%。尽管GA事件不是预先指定的临床终点，但结果支持了早期治疗干性AMD疾病的总体安全性益处。。

“We have been working hard to bring Valeda, a multiwavelength photobiomodulation device to our U.S. patients for several years. We now have a non-invasive treatment option for dry AMD patients that may improve vision and address the disease earlier, before permanent vision loss,” stated Clark Tedford, Ph.D., President and CEO.

总裁兼首席执行官克拉克·特德福德（Clark Tedford）博士表示：“多年来，我们一直在努力将多波长光生物调节装置Valeda带给美国患者。我们现在为干性AMD患者提供了一种非侵入性治疗选择，可以在永久性视力丧失之前改善视力并尽早解决疾病。”。

“The FDA authorization of the Valeda treatment to improve vision in dry AMD now provides a significant option for our US patients.”.

“FDA授权Valeda治疗以改善干性AMD的视力，现在为我们的美国患者提供了一个重要的选择。”。

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, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-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脸、开车或做特写工作，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 LumiThera

关于LumiThera

LumiThera, Inc. is an ophthalmic medical device company that is Harnessing the Power of Light™ to offer a comprehensive approach for detecting, treating, and monitoring retinal diseases, particularly dry AMD.

LumiThera，Inc.是一家眼科医疗器械公司，利用Light™的强大功能，为检测、治疗和监测视网膜疾病（尤其是干性AMD）提供全面的方法。

LumiThera is the leader in ophthalmic photobiomodulation (PBM) innovation with its flagship product, the Valeda® Light Delivery System. Multiwavelength Valeda treatments are for patients suffering from dry AMD. The Food & Drug Administration (FDA) has authorized marketing of Valeda Treatment for dry AMD Patients to Improve Vision.

LumiThera是眼科光生物调节（PBM）创新的领导者，其旗舰产品Valeda®光传输系统。多波长Valeda治疗适用于患有干性AMD的患者。美国食品和药物管理局（FDA）已授权销售Valeda治疗干性AMD患者以改善视力。

Valeda is CE Marked in the EU and is available in select countries in Latin America..

Valeda在欧盟有CE标志，并在拉丁美洲的某些国家提供。。

AdaptDx Pro® is a portable dark adaptometer that utilizes AI to deliver a uniform patient experience. Impaired dark adaptation is the earliest biomarker of dry AMD and can be detected three years before clinical presentation. AdaptDx Pro is available in the U.S. and Canada.

AdaptedX Pro®是一种便携式暗适应仪，利用人工智能提供统一的患者体验。暗适应受损是干性AMD最早的生物标志物，可以在临床表现前三年检测到。AdaptedX Pro在美国和加拿大提供。

NOVA Vision Testing System is a comprehensive electrophysiology platform that provides objective assessment of the entire pathway for visual and neuro-visual disorders. VEP is available in the U.S. and select countries outside of the U.S. ERG is only available outside of the U.S.

NOVA视觉测试系统是一个全面的电生理平台，可对视觉和神经视觉障碍的整个途径进行客观评估。VEP在美国和美国以外的某些国家/地区可用。ERG仅在美国以外的国家/地区可用。