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Luminopia宣布Anthem Blue Cross和Blue Shield已批准其弱视治疗方案的覆盖范围

Luminopia Announces That Anthem Blue Cross and Blue Shield Has Approved Its Amblyopia Treatment for Coverage

CISION 等信源发布 2025-05-08 21:00

可切换为仅中文


This will expand access to Luminopia's engaging, evidence-based treatment for children and allow more patients to benefit from its unique approach to treating amblyopia

这将扩大儿童获取Luminopia有趣且基于证据的治疗的机会,并让更多患者从其独特的弱视治疗方法中受益。

CAMBRIDGE, Mass.

马萨诸塞州剑桥市

,

May 8, 2025

2025年5月8日

/PRNewswire/ --

/PRNewswire/ --

Luminopia, Inc.

光亮opia公司

, a digital health company pioneering a new class of treatments for neuro-visual disorders, today announced that Anthem Blue Cross and Blue Shield has approved its amblyopia treatment for coverage. Patients who meet Anthem's criteria will now have Luminopia covered by their plan. This is a significant step forward in ensuring that more children nationwide can have access to this FDA-cleared treatment option for amblyopia..

,一家开创神经视觉障碍治疗新领域的数字健康公司,今天宣布Anthem蓝十字和蓝盾已批准将其弱视治疗纳入覆盖范围。符合Anthem标准的患者现在可以通过他们的计划获得Luminopia的覆盖。这是确保全国更多儿童能够获得这种经FDA批准的弱视治疗选择的重要一步。

Anthem is the second largest health plan in the U.S. and now their members with amblyopia will have the option to watch TV as treatment and benefit from Luminopia's unique, dual-acting mechanism of action – an approach that differs from traditional therapies and one that can be easily incorporated into a child's daily life..

Anthem是美国第二大健康计划公司,现在,其患有弱视的会员将可以选择通过看电视作为治疗手段,并受益于Luminopia独特的双重作用机制——这一方法不同于传统疗法,并且可以轻松融入孩子的日常生活。

'This coverage milestone brings us closer to our goal of helping as many amblyopia patients as we can,' said

“这一覆盖范围的里程碑使我们更接近帮助尽可能多的弱视患者的目标,”

Scott Xiao

肖恩(Scott Xiao)

, Luminopia's Co-Founder and CEO. 'We're proud to be addressing a significant unmet need in amblyopia care today by further increasing access to our unique and effective software-driven treatment that's backed by strong clinical data and multiple FDA clearances.'

卢米诺皮亚的联合创始人兼首席执行官表示:“我们很自豪能够通过进一步增加获得我们独特且有效的软件驱动治疗的机会,来满足当今弱视护理中的重大未满足需求。该治疗得到了强有力的临床数据和多项FDA批准的支持。”

Luminopia works differently than traditional amblyopia treatments such as eye-patching and blurring eye drops. Rather than blocking the stronger eye like traditional treatments, Luminopia uses a unique, binocular method that encourages both eyes to work together. Patients watch popular, kid-friendly TV shows inside a VR headset for one hour a day, six days a week, making the treatment more engaging and leading to approximately 94% of parents preferring Luminopia over eye-patching.

Luminopia 的工作原理不同于传统弱视治疗方法,如眼罩遮盖和模糊眼药水。Luminopia 并不像传统疗法那样遮挡较强的眼睛,而是采用一种独特的双眼方法,鼓励两只眼睛协同工作。患者每天佩戴 VR 头显观看一小时、每周六天的热门儿童电视节目,使治疗更具吸引力,并且约 94% 的家长更倾向于选择 Luminopia 而非眼罩遮盖。

Clinical trials demonstrated significant vision improvement in as little as four weeks, in both newly diagnosed patients and in children who had already tried traditional therapies..

临床试验表明,无论是新诊断的患者还是已经尝试过传统疗法的儿童,都可以在短短四周内显著改善视力。

'It is incredibly encouraging that an innovative treatment option like Luminopia has become more accessible to children,' said Dr.

“像Luminopia这样创新的治疗选项能够更广泛地提供给儿童,这非常令人鼓舞,”博士说道。

Derek Sprunger

德里克·斯普朗格

, Professor at

,教授于

Indiana University School of Medicine

印第安纳大学医学院

, Pediatric Ophthalmology & Strabismus. 'We are witnessing a transformative moment in amblyopia care, with more children gaining access to a therapy that not only improves outcomes but is also enjoyable to use. This represents a crucial step toward fewer children being left at risk of permanent vision loss.'.

,儿科眼科与斜视。“我们正在见证弱视治疗的一个变革性时刻,越来越多的孩子能够获得一种不仅改善效果而且使用愉快的治疗。这是朝着减少儿童面临永久性视力丧失风险迈出的关键一步。”

This news underscores Luminopia's continued momentum and arrived just a week after the U.S. Food & Drug Administration (FDA) cleared Luminopia's treatment for patients aged 8 to 12 years, expanding its previous label from patients 4 to 7 years old to patients 4 to <13 years old.

这一消息突显了Luminopia的持续发展势头,并且是在美国食品和药物管理局(FDA)批准Luminopia用于8至12岁患者的治疗一周后发布的,该治疗之前适用于4至7岁的患者,现在扩大到4至未满13岁的患者。

Luminopia is being prescribed by physicians at top eye institutes, children's hospitals and private practices across the U.S. today. Eye care professionals can prescribe through CoAssist Pharmacy.

Luminopia 目前正由美国顶级眼科机构、儿童医院和私人诊所的医生开处方。眼科护理专业人士可以通过 CoAssist 药房开具处方。

For more information, visit

欲了解更多信息,请访问

www.luminopia.com

www.luminopia.com

.

About Luminopia, Inc.

关于Luminopia公司

Luminopia, Inc. is pioneering a new class of treatments for significant neuro-visual disorders. Luminopia is committed to creating digital therapeutics that are both rigorously evaluated for FDA approval and genuinely engaging for patients. The company is an Innovation Partner of Boston Children's Hospital and developed its lead product to improve vision in children with amblyopia, the leading cause of vision loss among children.

Luminopia公司正在开创一类全新的、针对严重神经视觉障碍的治疗方法。Luminopia致力于开发既经过FDA严格评估又真正吸引患者的数字疗法。该公司是波士顿儿童医院的创新合作伙伴,并研发了其主要产品,用于改善患有弱视(儿童视力丧失的主要原因)的儿童的视力。

For more information, visit .

欲了解更多信息,请访问。

luminopia.com

luminopia.com

.

About Luminopia

关于Luminopia

Luminopia is the first FDA-approved¹ digital therapeutic for a neuro-visual disorder, indicated to improve vision in children with amblyopia. With Luminopia, patients choose TV shows and movies to watch from a selection of 1100+ hours of popular, engaging and educational content. Dual-acting algorithms modify the selected videos in real-time within a virtual reality (VR) headset to promote weaker eye usage and encourage patients' brains to combine input from both eyes.

Luminopia 是首个获 FDA 批准¹ 的用于神经视觉障碍的数字疗法,旨在改善患有弱视的儿童的视力。通过 Luminopia,患者可以从 1100 多小时的热门、有趣且富有教育性的内容中选择电视节目和电影观看。双重作用算法在虚拟现实 (VR) 耳机中实时修改所选视频,以促进较弱眼睛的使用,并鼓励患者大脑整合来自双眼的输入信息。

Unlike conventional treatments like eye-patching, blurring (atropine) eye drops and other digital therapies, which just penalize the stronger eye, Luminopia teaches patients to use both eyes together in a unique, binocular manner..

与传统治疗方法(如眼罩、模糊化(阿托品)眼药水和其他数字疗法)不同,这些方法只是惩罚较强的眼睛,而Luminopia则以一种独特的双目方式教导患者一起使用双眼。

Luminopia has been cleared by the FDA for children aged 4 to <13 years and validated through a series of clinical trials as well as a real-world registry. The Phase 3 pivotal trial was the first successful, randomized, controlled trial of a novel amblyopia treatment in almost 15 years, and the

Luminopia 已经获得 FDA 批准,适用于 4 至未满 13 岁的儿童,并通过了一系列临床试验以及真实世界注册数据的验证。第三阶段关键试验是近 15 年来首个成功、随机、对照的新型弱视治疗方法试验,而且

results were published in Ophthalmology

结果发表在《眼科》杂志上

, leading to the initial FDA approval for patients aged 4 to 7 years. Based on the robust real-world evidence collected through the PUPiL Registry, the FDA determined that Luminopia's safety and efficacy in patients aged 8-12 years is substantially equivalent to its safety and efficacy in patients aged 4 to 7 years, leading to a subsequent label expansion clearance..

,这使得FDA最初批准了4至7岁患者使用。基于通过PUPiL登记收集到的强有力的现实世界证据,FDA认定Luminopia在8-12岁患者中的安全性和有效性与其在4至7岁患者中的安全性和有效性基本相当,从而获得了随后的标签扩展许可。

For more information, visit

欲了解更多信息,请访问

luminopia.com

luminopia.com

.

¹De Novo granted in

De Novo 已授予

Oct 2021

2021年10月

, 510(k) clearance in

,510(k) 清关在

Apr 2025

2025年4月

to expand the age range.

扩大年龄范围。

I

ndications for Use for Luminopia

Luminopia的使用指征

Luminopia is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia is indicated for improvement in visual acuity in amblyopia patients, aged 4 to <13, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional.

Luminopia 是一种纯软件的数字治疗方案,设计用于与商业可购得且与该软件应用兼容的头戴式显示器(HMD)配合使用。Luminopia 适用于 4 至未满 13 岁、伴有屈光参差和/或轻度斜视的弱视患者,改善其视力,并需遵循训练有素的眼科保健专业人士所规定的治疗指导(频率与时长)。

Luminopia is intended for both previously treated and untreated patients. Luminopia is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia therapy. Luminopia is intended for prescription use only, in an at-home environment..

Luminopia 适用于既往接受过治疗和未接受过治疗的患者。Luminopia 应作为全时段屈光矫正(如眼镜)的辅助工具使用,在进行 Luminopia 治疗时,还应在头戴式显示器下佩戴此类矫正工具。Luminopia 仅限处方使用,且适用于家庭环境。

SOURCE Luminopia

来源:Luminopia

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