博士伦在美国推出Arise™角膜塑形镜系统-动脉网

Bausch + Lomb Launches Arise™ Orthokeratology Lens System in the United States

博士伦等信源发布 2025-03-17 19:45

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VAUGHAN, Ontario

万锦市，安大略省

--(BUSINESS WIRE)--Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced the

--（商业资讯）-- 博士伦公司（Bausch + Lomb Corporation，纽约证券交易所/多伦多证券交易所代码：BLCO），一家致力于帮助人们通过改善视力来提升生活质量的全球领先眼科保健公司，今天宣布了

U.S.

美国

launch of Arise, a lens fitting system that uses intelligent, cloud-based technology to streamline the orthokeratology lens design process. Arise seamlessly syncs directly with topographers – diagnostic tools that capture 3-D images of the eye – to create precise lens designs in seconds to treat myopia.

Arise的推出，这是一款利用智能云技术的眼镜适配系统，可简化角膜塑形镜设计流程。Arise能够与角膜地形图仪——捕捉眼睛三维图像的诊断工具——无缝对接，数秒内生成精确的镜片设计，用于治疗近视。

These lenses include the first orthokeratology lens design with toric peripheral curves* approved by the .

这些镜片包括第一个获得批准的带有散光周边曲线的角膜塑形镜设计。

U.S.

美国

Food and Drug Administration to treat myopia overnight.

食品药品监督管理局夜间治疗近视。

Myopia, or nearsightedness, is one of the most common ocular disorders worldwide and a leading cause of visual impairment in children.

近视，或称短视，是全球最常见的视力障碍之一，也是儿童视力受损的主要原因之一。

Studies predict the global prevalence of myopia will rise from 28% of the world's population (two billion people) in 2010 to 50% of the world's population (five billion people) by 2050.

研究表明，全球近视的患病率将从2010年全球人口的28%（二十亿人）上升到2050年全球人口的50%（五十亿人）。

“Traditional orthokeratology lens fitting methods can be complex and time-consuming,” said Yang Yang, president, Global Vision Care, Bausch + Lomb. “The Arise platform’s streamlined fitting process will reduce chair time† and increase efficiency for eye care professionals.”

“传统角膜塑形镜片的适配方法可能复杂且耗时，”博士伦全球视力保健部总裁杨阳表示。“Arise 平台简化的适配流程将减少医生与患者面对面的时间，并提高眼科护理专业人士的工作效率。”

Engineered for precision and speed, Arise uses advanced algorithms to instantly interpret corneal topography images and recommend lens designs in seconds – no fitting set required. It is designed for lens fitters of all experience levels and efficiently evaluates lens centration and patient progress using its overnight outcome map library, recommending adjustments following overnight wear, if needed.

Arise 专为精确和速度而设计，利用先进的算法即时解读角膜地形图图像，并在数秒内推荐镜片设计——无需适配工具。它适合各种经验水平的镜片适配师，能够高效评估镜片中心定位和患者进展，通过其隔夜结果地图库推荐调整方案，必要时可根据隔夜佩戴情况提出建议。

Additionally, the cloud-based platform allows secure access to patient data from anywhere and direct support from the Bausch + Lomb expert consultation team..

此外，基于云的平台允许从任何地方安全访问患者数据，并直接获得博士伦专家咨询团队的支持。

“Arise combines all aspects of the orthokeratology process—from topography capture to lens design and more—into one seamless, user-friendly technology,” said Brooke Messer, OD, FAAO, FSLS, Vance Thompson Vision,

“Arise 将角膜塑形术过程的各个方面——从地形捕捉到镜片设计等——整合为一项无缝且用户友好的技术，”Brooke Messer，OD，FAAO，FSLS，Vance Thompson Vision 表示。

West Fargo, North Dakota

北达科他州西法戈

. “The ease and precision of Arise will be a welcome addition to my practice.”

“Arise的简便性和精确性将为我的实践带来可喜的补充。”

Arise is now commercially available in

Arise 现已商业发售

the United States

美国

, the

，这个

United Kingdom

英国

and

和

Europe

欧洲

。

*Based on clinical study data

*基于临床研究数据

INDICATIONS FOR USE

使用指征

Boston Orthokeratology (oprifocon A) shaping lenses for overnight wear are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear as part of the Bausch + Lomb Vision Shaping Treatment VST

波士顿角膜塑形镜（oprifocon A）用于夜间佩戴的塑形镜片，适用于非病理性眼睛减少近视屈光误差。该镜片作为博士伦视觉塑形治疗（VST）的一部分，适合夜间佩戴。

process for the temporary reduction of myopia up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters. The lenses may only be disinfected using a chemical disinfection system.

对于散光高达1.50屈光度的眼睛，暂时减少高达5.00屈光度近视的过程。这些镜片只能使用化学消毒系统进行消毒。

SAFETY INFORMATION CONTRAINDICATIONS

安全信息禁忌症

DO NOT USE the Boston Orthokeratology (oprifocon A) shaping lenses when any of the following conditions exist:

当存在以下任何情况时，请勿使用波士顿角膜塑形术（oprifocon A）塑形镜片：

WARNINGS

警告

The risk of ulcerative keratitis has been shown to be greater among wearers of extended wear lenses than among wearers of daily wear lenses. The risk among extended wear use users increases the number of consecutive days that lenses are worn between removals, beginning with the first overnight use. Smoking increases the risk of ulcerative keratitis for contact lens wearers.

研究表明，长期佩戴隐形眼镜者比日戴型隐形眼镜者患溃疡性角膜炎的风险更大。长期佩戴者的风险随着连续佩戴天数的增加而增加，从第一次过夜使用开始。吸烟会增加隐形眼镜佩戴者患溃疡性角膜炎的风险。

Wearing the lenses continuously (extended wear) presents increased risk, which increases with the number of consecutive days the lenses are worn between removals. Although the safety risks of overnight wear with removal upon wakening may not be as great as with extended wear, there is still increased risk beginning with the first overnight period.

连续佩戴镜片（延长佩戴）会增加风险，这种风险随着连续佩戴天数的增加而增加。虽然夜间佩戴并在醒来时摘除的安全风险可能不如延长佩戴那么大，但从第一个夜间佩戴开始仍然存在增加的风险。

。

PRECAUTIONS

注意事项

When selecting an appropriate lens design and parameters, the eye care practitioner should consider all factors that affect lens performance and the patient’s ocular health; including oxygen permeability, wettability, central and peripheral thickness, and optic zone diameter.

选择合适的眼镜设计和参数时，眼保健从业者应考虑所有影响镜片性能和患者眼部健康因素；包括氧气渗透性、润湿性、中心和周边厚度以及光学区域直径。

ADVERSE EVENTS

不良事件

A total of 378 eyes (191 patients) were enrolled in a clinical study. There were twelve significant lens-related adverse events reported in ten subjects. All eyes that showed acuity reductions were documented as returning to normal vision, except two eyes of one subject with severe corneal staining that showed ≥2 lines loss of BSCVA.

共有378只眼（191名患者）参与了一项临床研究。在十名受试者中报告了十二起与镜片相关的严重不良事件。所有视力下降的眼睛均记录为恢复到正常视力，除了一名严重角膜染色的受试者的两只眼睛，其BSCVA视力损失≥2行。

The return to pre-treatment VA was not recorded for this subject, although the subject returned to soft contact lens wear and verbally reported that vision was normal. All adverse events resolved without further complications. A separate clinical study evaluated the effect of non-spherical (toric) peripheral curves on 45 astigmatic patients who were orthokeratology lens-naïve.

虽然该受试者恢复了软性隐形眼镜的佩戴，并口头报告视力正常，但未记录其恢复至治疗前的视力。所有不良事件均在无进一步并发症的情况下得到解决。另一项临床研究评估了非球面（散光）周边曲线对45名未曾使用过角膜塑形镜的散光患者的影响。

Among the dispensed subjects, no significant adverse events were reported..

在分配的受试者中，没有报告严重的不良事件。

ATTENTION:

注意：

Refer to the package insert for a complete listing of indications, warnings and precautions, clinical trial information, etc.

请参阅包装说明书，了解适应症、警告和注意事项、临床试验信息等的完整列表。

CAUTION:

注意：

Federal (

联邦（

USA

美国

) law restricts this device to the sale by, or on the order of a licensed practitioner.

法律限制此设备仅可通过持照从业者销售或根据其指示销售。

About Orthokeratology

关于角膜塑形术

Orthokeratology, or ortho-k, is a non-surgical procedure that is primarily used to correct nearsightedness (myopia). It uses specially designed contact lenses to temporarily reshape the cornea and improve vision. The lenses are worn overnight to gradually correct the shape of the cornea, allowing the eyes to focus light more effectively onto the retina..

角膜塑形术（Orthokeratology），或简称 ortho-k，是一种非手术程序，主要用于矫正近视。它使用特殊设计的隐形眼镜暂时重塑角膜形状并改善视力。这种镜片通常在夜间佩戴，逐渐矫正角膜的形状，使眼睛能够更有效地将光线聚焦到视网膜上。

About Bausch + Lomb

关于博士伦

Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments.

Bausch + Lomb致力于保护和增强全世界数百万人的视力礼物——从出生到生命的每个阶段。其约400种产品的综合产品组合包括隐形眼镜、镜片护理产品、眼部护理产品、眼科药物、非处方产品以及眼科手术设备和仪器。

Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,500 employees and a presence in approximately 100 countries. Bausch + Lomb is headquartered in .

成立于1853年的博士伦在全球范围内有着重要的研究与开发、制造和商业足迹，拥有大约13,500名员工，业务遍及约100个国家。博士伦总部位于。

Vaughan, Ontario

万锦市，安大略省

, with corporate offices in

，公司办公室位于

Bridgewater, New Jersey

新泽西州布里奇沃特

. For more information, visit

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www.bausch.com

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