Luminopia, Inc., a digital health company pioneering a new class of treatments for neuro-visual disorders, today announced that the U.S. Food & Drug Administration (FDA) cleared its amblyopia treatment for patients aged 8 to 12 years, expanding its existing label from patients 4 to 7 years old to patients 4 to <13 years old with amblyopia associated with anisometropia and/or mild strabismus.

Luminopia, Inc.，一家数字健康公司，开创了神经视觉疾病治疗的新类别，今天宣布美国食品和药物管理局（FDA）已批准其针对8至12岁患者的弱视治疗方案，将其现有的适应症从4至7岁患者扩展到4至未满13岁伴有屈光参差和/或轻度斜视相关的弱视患者。

This opens the door to a new treatment option for about 400,000 8- to 12-year-olds in the U.S. suffering from amblyopia and marks the first FDA clearance for an amblyopia treatment for this age range in more than two decades..

这为美国大约 40 万名 8 至 12 岁患有弱视的儿童开启了新的治疗选择，并且标志着二十多年来 FDA 首次批准针对这一年龄段的弱视治疗方案。

The FDA's decision was based on Luminopia's robust database of Real-World Evidence (RWE), generated through its

FDA的决定是基于Luminopia强大的真实世界证据（RWE）数据库，该数据库通过其生成。

uminopia (PUPiL) Registry™ (NCT06429280). The largest amblyopia treatment registry to-date, the PUPiL Registry uses an all-comers' design to evaluate real-world outcomes in a representative population. It's comprised of more than 500 patients and counting, from 45 prescribers at 14 academic and community centers including Boston Children's Hospital, Children's Hospital of .

uminopia (PUPiL) 注册登记™ (NCT06429280)。迄今为止规模最大的弱视治疗注册登记，PUPiL 注册采用了全面覆盖的设计，以评估在具有代表性人群中的真实世界结果。该注册涵盖了来自14个学术和社区中心的45名开处方者提供的超过500名患者，并且数量还在增加，其中包括波士顿儿童医院、费城儿童医院等。

, UCSF Benioff Children's Hospitals and The Johns Hopkins Wilmer Eye Institute. The PUPiL Registry, combined with data from Luminopia's Phase 1, 2 and 3 clinical trials, make Luminopia the most thoroughly studied digital treatment for amblyopia.

，加州大学旧金山分校贝尼奥夫儿童医院和约翰霍普金斯威尔默眼科研究所。PUPiL 注册登记结合了 Luminopia 第一、第二和第三阶段临床试验的数据，使 Luminopia 成为治疗弱视研究最彻底的数字疗法。

The FDA determined that Luminopia's safety and efficacy in patients aged 8 to 12 years is substantially equivalent to its safety and efficacy in patients aged 4 to 7 years. Additionally, patients in Luminopia's PUPiL Registry were treated with traditional therapies for an average of 1.8 years prior to switching to Luminopia and they were still able to gain an additional line of vision..

FDA认定，Luminopia在8至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。此外，在Luminopia的PUPiL注册研究中，患者在转用Luminopia之前平均接受传统治疗1.8年，之后仍能额外提升一行视力。

'It's rare for the FDA to provide clearance based on RWE alone and, as far as we're aware, this is the first instance of it being done in ophthalmology. The FDA's decision is a testament to the rigorous design of the PUPiL Registry and the strength of our product's safety and efficacy,' said

“FDA 很少仅基于真实世界证据（RWE）提供批准，而且据我们所知，这是在眼科领域的首例。FDA 的决定证明了 PUPiL 注册研究的严谨设计以及我们产品安全性和有效性的强大支持，”他表示。

Scott Xiao

肖恩（Scott Xiao）

, Luminopia's Co-Founder and CEO. 'We're proud to offer a new treatment option for 8- to 12-year-old amblyopia patients, addressing the unmet need for effective therapies as the efficacy of traditional approaches like eye-patching is known to decline significantly after age 8.'

，Luminopia的联合创始人兼首席执行官。“我们很自豪能够为8至12岁的弱视患者提供一种新的治疗选择，解决传统方法（如眼罩）在8岁后疗效显著下降的有效治疗需求未被满足的问题。”

Amblyopia, commonly known as lazy eye, is the leading cause of vision loss in children and statistically affects about one child in every classroom. Luminopia works differently than traditional therapies, such as eye-patching and atropine eye drops, by taking a unique, binocular approach to treating amblyopia.

弱视，通常称为懒惰眼，是导致儿童视力丧失的主要原因，据统计，每个教室大约就有一个孩子受到影响。Luminopia 与传统疗法（如眼罩和阿托品滴眼液）不同，它采用了一种独特的双眼方法来治疗弱视。

Luminopia allows patients to watch their favorite TV shows through an immersive VR headset for one hour a day, six days a week and overlays therapeutic algorithms that engage both eyes to treat the condition. With access to 75 carefully curated, kid-friendly shows like Sesame Street and SpongeBob SquarePants, Luminopia encourages patient engagement and can lead to significantly improved vision at 12 weeks as demonstrated in clinical studies – even in patients who have been previously treated with traditional therapies..

Luminopia允许患者每天通过沉浸式VR头盔观看他们最喜欢的电视节目，每周六天，每次一小时，并叠加治疗算法，使双眼参与治疗该疾病。通过访问75个经过精心挑选、适合儿童的电视节目（如《芝麻街》和《海绵宝宝》），Luminopia鼓励患者积极参与，临床研究表明，即使是对之前接受过传统疗法的患者，在12周内也能显著改善视力。

'Luminopia is the only treatment for amblyopia that has demonstrated comparable efficacy in young children and pre-teens,' said

Luminopia是唯一一种在幼儿和青少年中显示出相似疗效的弱视治疗方法，

Robert Gold

罗伯特·戈尔德

, M.D., F.A.A.P., a pediatric ophthalmologist with Eye Physicians of

，医学博士，美国儿科学会会员，眼科医生协会会员，Eye Physicians of 的小儿眼科医生

Central Florida

中佛罗里达

and Past-President of the American Association for Pediatric Ophthalmology and Strabismus (AAPOS). 'I look forward to offering this innovative treatment option to my 8- to 12-year-old patients, including those who have tried other therapies that didn't work for them.'

美国小儿眼科和斜视协会（AAPOS）的前任主席。“我期待为我的8至12岁的患者提供这种创新的治疗选择，包括那些尝试过其他疗法但无效的患者。”

Luminopia can be prescribed by eye care professionals today through CoAssist Pharmacy. For more information, visit

如今，眼科护理专业人士可以通过CoAssist药房开具Luminopia处方。欲了解更多信息，请访问

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、针对重大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，并研发了其主导产品，旨在改善患有弱视的儿童视力，弱视是儿童视力丧失的主要原因。

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 是首款获 FDA 批准¹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，患者可从 1100 多小时的热门、有趣且富有教育意义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，并鼓励患者的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）滴眼液和其他数字疗法）不同，这些方法只是惩罚较强的眼睛，而Luminopia则以一种独特的、双眼协同的方式教导患者同时使用双眼。

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 已获得 FDA 批准，适用于 4 至未满 13 岁的儿童，并通过一系列临床试验以及真实世界登记验证。第三阶段关键试验是近 15 年来首个成功的、随机的、对照的新型弱视治疗方法试验，并且...

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 to 12 years is substantially equivalent to its safety and efficacy in patients aged 4 to 7 years, leading to a subsequent label expansion clearance..

，从而获得了FDA对4至7岁患者的初步批准。基于通过PUPiL注册收集到的强有力的真实世界证据，FDA认定Luminopia在8至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，从而获得了后续的标签扩展许可。

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疗法，旨在与可商业获取且与该软件兼容的头戴式显示器（HMD）一起使用。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，以改善其视力，这些患者需按照经过培训的眼科保健专业人士的指示接受治疗（频率和持续时间）。

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 适用于曾经接受过治疗和未接受治疗的患者。Luminopia 旨在作为全时段屈光矫正（例如眼镜）的辅助工具，在 Luminopia 治疗期间也应佩戴在头戴式显示器下。Luminopia 仅限处方使用，适用于家庭环境。