LumiThera has announced promising results from its LIGHTSITE 3B extension trial, highlighting continued visual acuity improvements in patients with dry age-related macular degeneration (AMD). The study builds on earlier findings from the pivotal LIGHTSITE 3 trial and provides further evidence supporting the long-term efficacy and safety of the Valeda Light Delivery System—the first FDA-authorized treatment aimed at improving vision in dry AMD..

LumiThera宣布了其LIGHTSITE 3B扩展试验的积极结果，强调了干性年龄相关性黄斑变性（AMD）患者视力的持续改善。该研究基于此前关键性的LIGHTSITE 3试验的结果，并进一步提供了支持Valeda光递送系统长期有效性和安全性的证据，该系统是首个获FDA批准旨在改善干性AMD患者视力的治疗方法。

LIGHTSITE 3B Extension Trial Overview

LIGHTSITE 3B扩展试验概述

The LIGHTSITE 3B extension trial is a prospective, open-label study designed to evaluate the long-term benefits of Valeda in patients with dry AMD. Participants from the original LIGHTSITE 3 pivotal trial were enrolled for an additional 13-month treatment cycle using the Valeda Light Delivery System.

LIGHTSITE 3B扩展试验是一项前瞻性、开放标签的研究，旨在评估Valeda对干性AMD患者的长期益处。原LIGHTSITE 3关键试验的参与者被纳入使用Valeda光递送系统进行额外13个月的治疗周期。

Notably, this follow-up trial took place after a 20-month treatment hiatus, allowing for an assessment of sustained and renewed visual improvement upon retreatment..

值得注意的是，这次随访试验是在中断治疗20个月后进行的，从而能够评估再次治疗时持续和重新获得的视力改善情况。

FDA Approval and Valeda’s Clinical Significance

FDA批准与Valeda的临床意义

Valeda received FDA authorization in November 2024, becoming the first approved treatment aimed at improving vision in patients with dry AMD. During the LIGHTSITE 3 trial, the system achieved its primary endpoint by demonstrating safety and efficacy, with participants showing an average improvement in best corrected visual acuity (BCVA) of over five letters—equivalent to one line on a standard eye chart—over a 24-month period..

Valeda于2024年11月获得FDA批准，成为首个旨在改善干性AMD患者视力的治疗方法。在LIGHTSITE 3试验期间，该系统通过证明其安全性和有效性达到了主要终点，参与者在24个月的时间里最佳矫正视力（BCVA）平均提高了超过五个字母，相当于标准视力表的一行。

Extension Trial Results: Sustained Vision Benefits

扩展试验结果：持续的视力益处

According to Dr. David Boyer, MD, FASRS, from Retina Vitreous Associates Medical Group in Beverly Hills, California, “The LIGHTSITE 3B extension trial results extend 2-year pivotal trial vision benefits out to 4.5 years and showed an excellent safety profile.” He emphasized the significance of maintaining visual gains during the 20-month no-treatment period between trials and further vision recovery upon retreatment..

根据加利福尼亚州比佛利山庄Retina Vitreous Associates医疗集团的医学博士、FASRS会员大卫·博耶尔医生的说法：“LIGHTSITE 3B扩展试验结果将为期两年的关键试验视力益处延长至4.5年，并显示出极佳的安全性。”他强调了在两次试验之间长达20个月的无治疗期内保持视力增益的重要性，以及再次治疗后视力进一步恢复的意义。

Clinical Data Presented at ARVO 2025

ARVO 2025年会上展示的临床数据

The detailed findings were presented on May 7 at the 2025 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) by co-investigators Diane Do, MD, FASRS, and Quan Dong Nguyen, MD, MSc, FARVO, FASRS, from the Byers Eye Institute at Stanford University.

详细研究结果由斯坦福大学拜尔斯眼科研究所的 Diane Do 医学博士、FASRS 和 Quan Dong Nguyen 医学博士、理学硕士、FARVO、FASRS 于 2025 年 5 月 7 日在视觉与眼科研究协会 (ARVO) 年会上发表。

Dr. Quan Dong Nguyen remarked, “The primary endpoint of the trial was BCVA gain. After another 13 months of treatment, although the study population of LIGHTSITE 3B is relatively small, more than 60% of the subjects treated in both trials continued to show a vision improvement of over one line.” He added, “This is the first and only FDA-authorized treatment that can improve vision with benefits extending out to 4.5 years, underscoring the potential of earlier and sustained treatment for optimal outcomes.”.

阮泉东博士评论道：“该试验的主要终点是BCVA的提高。在另外13个月的治疗后，尽管LIGHTSITE 3B的研究人群相对较少，但两项试验中超过60%的受试者继续表现出视力提高超过一行。”他补充道：“这是首个且唯一获得FDA授权的可以改善视力的治疗方法，其益处可延续至4.5年，突显了早期和持续治疗以获得最佳效果的潜力。”

Implications for Dry AMD Treatment

干性AMD治疗的意义

Clark Tedford, PhD, President and CEO of LumiThera, stated, “There is now a non-invasive treatment for dry AMD patients that can improve vision and address the disease earlier, before permanent vision loss.” He highlighted the long-term significance of the extension trial, noting that Valeda may be altering the trajectory of vision loss and delivering sustainable improvements over several years with ongoing therapy..

LumiThera公司总裁兼首席执行官克拉克·特德福德博士表示：“现在有一种针对干性AMD患者的非侵入性治疗方法，可以在永久性视力丧失之前改善视力并及早应对疾病。”他强调了延长期试验的长期意义，指出Valeda可能正在改变视力丧失的轨迹，并通过持续治疗在数年内带来可持续的改善。