Decision is the Latest Milestone for Diffusion Optics Technology™ (DOT™)  Spectacle Lenses Designed to Slow Myopia Progression in Children

该决定是扩散光学技术™（DOT™）眼镜镜片的最新里程碑，旨在减缓儿童近视的进展

LOS ALTOS, Calif., Feb. 14, 2024 /PRNewswire/ -- SightGlass Vision, a joint venture of CooperCompanies and EssilorLuxottica that develops innovative technologies and science-based treatments to address the global myopia epidemic, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its Diffusion Optics Technology™ (DOT™) spectacle lenses, which are intended to slow myopia progression in children.

加利福尼亚州洛斯阿尔托斯，2024年2月14日/PRNewswire/--由CooperCompanies和EssilorLuxottica合资成立的SightGlass Vision公司今天宣布，美国食品和药物管理局（FDA）已授予其Diffusion Optics Technology™（DOT™）突破性设备名称，该公司开发创新技术和基于科学的治疗方法，以应对全球近视流行眼镜镜片，旨在减缓儿童近视的进展。

The unique design is the first to use the contrast management mechanism of action, incorporating thousands of elements that gently scatter light across the retina..

这种独特的设计是第一个使用对比度管理作用机制的设计，它结合了数千种元素，可以轻轻地将光线散射到视网膜上。。

The FDA's Breakthrough Devices Program is for highly innovative devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. Manufacturers are given more frequent opportunities for FDA feedback during the premarket review phase, as well as a prioritized submission review.

FDA的突破性设备计划是针对高度创新的设备，这些设备可以更有效地治疗或诊断威胁生命或不可逆转地使人衰弱的人类疾病或病症。在上市前审查阶段，制造商有更频繁的机会获得FDA的反馈，以及优先提交审查。

Since the program's introduction in 2015, only 18 other ophthalmic devices have received the Breakthrough Device designation.*.

自2015年该计划推出以来，只有18种其他眼科设备获得了突破性设备称号。*。

'The FDA Breakthrough Device designation for Diffusion Optics Technology™ (DOT™) spectacle lenses is a milestone for our organization—and for the broader fight against the pediatric myopia epidemic. Recent studies1,2 illustrate that about half of U.S. children are myopic, yet most are not receiving treatments proven to slow myopia progression,' said Andrew Sedgwick, CEO of SightGlass Vision.

“美国食品和药物管理局（FDA）针对扩散光学技术™（DOT™）眼镜镜片的突破性设备设计是我们组织和更广泛对抗小儿近视流行的里程碑。SightGlass Vision首席执行官安德鲁·塞奇威克（AndrewSedgwick）说，最近的研究1,2表明，大约一半的美国儿童患有近视，但大多数儿童没有接受证明可以减缓近视进展的治疗。

'We are enthusiastic about more closely collaborating with the FDA as we pursue U.S. market clearance.'.

“我们热衷于在寻求美国市场许可时与FDA进行更密切的合作。”。

SightGlass Vision's patent-protected technology has demonstrated proven efficacy and safety through rigorous clinical evaluation.3,4,5,6 As reported in September 2023, full four-year outcomes from the pivotal CYPRESS study showed statistically significant slowing of axial length progression and cycloplegic spherical equivalent refraction.7.

通过严格的临床评估，SightGlass Vision的专利保护技术已经证明了其有效性和安全性。3,4,5,6据2023年9月报道，关键的CYPRESS研究的四年完整结果显示，轴向长度进展和睫状肌麻痹的球面等效屈光度在统计学上显着减慢。

Diffusion Optics Technology™ (DOT™) spectacle lenses have made their commercial debut in several markets, including China, the Netherlands, and Israel, as well as through preliminary market trials in other countries. For more information, visit SightGlassVision.com.

Diffusion Optics Technology™（DOT™）眼镜镜片已在包括中国、荷兰和以色列在内的多个市场进行了商业首次亮相，并在其他国家进行了初步的市场试验。有关更多信息，请访问SightGlassVision.com。

About SightGlass Vision SightGlass Vision develops innovative technologies and science-based treatments to address the global myopia epidemic, backed by novel and comprehensive research. Its unique Diffusion Optics Technology™️ (DOT™) is based on ground-breaking discoveries surrounding myopia progression.

关于SightGlass Vision SightGlass Vision在新颖全面的研究支持下，开发创新技术和基于科学的治疗方法，以应对全球近视流行。其独特的扩散光学技术™️ （DOT™）基于围绕近视进展的开创性发现。

Spectacle lenses using its patent-protected approach incorporate thousands of light-scattering elements designed to mimic more natural contrast on the retina—a method intended to reduce myopia progression in children. The treatment has completed the three years pivotal multisite clinical study. Founded in 2016, the company now operates as a joint venture of CooperCompanies and EssilorLuxottica to accelerate commercialization opportunities and expand the myopia management category worldwide. .

使用受专利保护的方法的眼镜镜片包含数千个光散射元件，旨在模拟视网膜上更自然的对比度，这种方法旨在减少儿童近视的进展。该治疗已经完成了为期三年的关键性多部位临床研究。该公司成立于2016年，目前是CooperCompanies和EssilorLuxottica的合资企业，旨在加速商业化机会并扩大全球近视管理类别。。

SightGlass Vision™ Diffusion Optics Technology™ (DOT™) spectacle lenses are not available for sale in the United States.

SightGlass Vision™Diffusion Optics Technology™（DOT™）眼镜镜片在美国不出售。

* As of June 30, 2023. FDA Breakthrough Devices Program. Graph 2: Number of Granted Breakthrough Device Designations by Clinical Panel. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#metrics

*截至2023年6月30日。FDA突破设备计划。图2：临床小组授予的突破性设备名称的数量。https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#metrics

Media Contact Mike McDougall, APR, Fellow PRSA, FAAOMcDougall Communications for SightGlass Vision +1-585-545-1815 or [email protected]

媒体联系Mike McDougall，APR，研究员PRSA，FAAOMcDougall Communications for SightGlass Vision+1-585-545-1815或[电子邮件保护]

1 Kwan J, et al. Current Trends in Pediatric Eye Examinations and Contact Lens Prescribing in the U.S. Poster presentation at the Global Specialty Lens Symposium, January 2024.

1 Kwan J等人，《2024年1月全球专业镜片研讨会美国海报介绍中儿科眼科检查和隐形眼镜处方的当前趋势》。

2 Myopia Management 2024 Report, Jobson Optical Research, January 2024. https://reviewofmm.com/2024-myopia-report/

2《2024年近视管理报告》，Jobson Optical Research，2024年1月。https://reviewofmm.com/2024-myopia-report/

3 Control of myopia using Diffusion Optics Technology™ spectacle lenses: 12-month results of a randomised controlled, efficacy and safety study (CYPRESS). British Journal of Ophthalmology Published Online First: 01 September 2022. DOI: 10.1136/bjo-2021-321005

3使用Diffusion Optics Technology™眼镜镜片控制近视：一项随机对照，有效性和安全性研究（CYPRESS）的12个月结果。英国眼科杂志首次在线发布：2022年9月1日。内政部：10.1136/bjo-2021-321005

4 Rappon J., et al. Two-year effectiveness of a novel myopia management spectacle lens with full-time WEARERS. Invest. Ophthalmol. Vis. Sci. 2022;63(7):408.

4 Rappon J.等人。一种新型近视管理眼镜镜片对全职佩戴者的两年有效性。投资。眼科。可见。科学。2022年；63（7）：408。

5 Chalberg T., et al. Control of Myopia Using Diffusion Optics Spectacle Lenses: Efficacy and Safety Study (CYPRESS) 42-month results. ARVO 2023 Annual Meeting presentation. 27 April 2023.

5 Chalberg T.等人。使用扩散光学眼镜镜片控制近视：疗效和安全性研究（CYPRESS）42个月的结果。ARVO 2023年会介绍。2023年4月27日。

6 Laughton, D et al. Safety and Efficacy of a Novel Spectacle Lens for Myopia Control Over Three Years. 2022 American Academy of Optometry annual meeting. 27 Oct 2022.

6 Laughton，D等人。三年来用于近视控制的新型眼镜镜片的安全性和有效性。2022年美国验光学会年会。2022年10月27日。

7 Xiaoying Zhu, Deborah Laughton, Jennifer S. Hill, Marcella McParland, Vanessa Tasso, Jay Neitz, Maureen Neitz, Thomas W. Chalberg. Control of Myopia using Diffusion Optics Technology Spectacle Lenses: Efficacy and Safety Study (CYPRESS) 4 Year Results. Presented at CCOS 2023.

7朱晓颖，黛博拉·劳顿，詹妮弗·希尔，马塞拉·麦克帕兰德，瓦妮莎·塔索，杰伊·奈茨，莫林·奈茨，托马斯·查伯格。使用扩散光学技术控制近视眼镜镜片：疗效和安全性研究（CYPRESS）4年结果。在CCOS 2023上提交。

SOURCE SightGlass Vision

SOURCE SightGlass视觉