Alcon to Acquire LumiThera, Maker of Photobiomodulation Device for Dry AMD

爱尔康将收购干性AMD光生物调节设备制造商LumiThera

July 08, 2025

2025年7月8日

Alcon has announced plans to acquire LumiThera, strengthening its vitreoretinal surgery portfolio with the addition of LumiThera’s photobiomodulation (PBM) device for the treatment of early to intermediate dry age-related macular degeneration (AMD). Financial details of the agreement were not disclosed..

爱尔康宣布计划收购LumiThera，通过增加LumiThera用于治疗早期至中期干性年龄相关性黄斑变性（AMD）的光生物调节（PBM）设备，加强其玻璃体视网膜手术产品组合。协议的财务细节未披露。

Valeda: PBM Device with Clinical Evidence Supporting Vision Improvement

Valeda：具有支持视力改善临床证据的PBM设备

According to Alcon, LumiThera’s PBM technology is the only device that has demonstrated meaningful visual improvement compared to baseline in patients with early to intermediate dry AMD. The Valeda Light Delivery System received FDA de novo market authorization in November 2024 and earned CE Mark approval in November 2018.

根据爱尔康的说法，LumiThera的PBM技术是唯一一种在早期至中期干性AMD患者中相较于基线显示出显著视力改善的设备。Valeda光传递系统于2024年11月获得FDA的重新分类上市许可，并于2018年11月获得CE标志批准。

PBM therapy is currently available in Europe, Latin America, Singapore, the U.K., and the U.S..

PBM 疗法目前在欧洲、拉丁美洲、新加坡、英国和美国有售。

“Dry AMD is an area of significant unmet need, and PBM is an efficacious, noninvasive light therapy that can provide visual improvement for patients with early and intermediate disease,' said Sean Clark, Vice President and General Manager, Global Surgical Franchise at Alcon. “With Alcon’s global commercial and clinical expertise, we have the potential to make this therapy more broadly available to eye care professionals and their patients, while continuing to strengthen its body of clinical evidence.”.

“干性AMD是一个存在显著未满足需求的领域，而PBM作为一种有效的、非侵入性的光疗方法，可以为早期和中期患者提供视力改善。”爱尔康全球外科特许经营部副总裁兼总经理Sean Clark表示，“凭借爱尔康的全球商业和临床专业知识，我们有潜力让更多的眼科专业人士及其患者使用这种疗法，同时继续加强其临床证据的支持。”

How PBM Works

PBM的工作原理

Photobiomodulation utilizes low-level light to stimulate mitochondrial energy production, supporting retinal cellular health. Unlike laser therapy, it delivers three specific, science-backed wavelengths of non-phototoxic light. Treatments are non-invasive and performed while the patient sits comfortably in a clinical setting..

光生物调节利用低强度光刺激线粒体能量产生，支持视网膜细胞健康。与激光治疗不同，它传递三种特定的、有科学依据支持的非光毒性光波长。治疗是非侵入性的，患者在临床环境中舒适地坐着即可接受治疗。

Clinical Evidence Supporting PBM

支持PBM的临床证据

Data from LIGHTSITE I, II, and III clinical trials have shown that PBM treatments lead to improvements in visual acuity without treatment-related serious adverse events. The pivotal LIGHTSITE III study, conducted at 10 sites across the U.S., evaluated two years of PBM versus control light therapy and reported:.

LIGHTSITE I、II 和 III 临床试验的数据表明，PBM 治疗能够改善视力，且没有与治疗相关的严重不良事件。关键性的 LIGHTSITE III 研究在美国的 10 个地点进行，评估了两年的 PBM 与对照光疗，并报告称：

• Patients with PBM-treated eyes gained approximately one line of visual acuity (ETDRS) from baseline at months 13, 21, and maintained at month 24.

• 接受PBM治疗的患者在第13个月、第21个月时，视力（ETDRS）较基线水平提高了大约一行，并在第24个月保持稳定。

• About 88% of patients in the PBM group maintained or gained vision versus baseline at month 24.

• 在第24个月时，约88%的PBM组患者维持或提高了相对于基线的视力。

• Nearly 64% of patients experienced an improvement of at least one line of visual acuity from baseline at month 24.

• 在第24个月时，近64%的患者从基线水平至少提高了一行视力。

• More than 97% of patients reported no pain or discomfort during therapy.

• 超过97%的患者报告在治疗过程中没有疼痛或不适。

• Over 80% of patients remained on therapy for the recommended two-year treatment course.

• 超过80%的患者在推荐的两年治疗过程中继续接受治疗。

Clark Tedford, PhD, President and CEO of LumiThera, stated:

克拉克·特德福德博士，LumiThera公司总裁兼首席执行官表示：

“We are thrilled that Alcon agrees in the potential that this device has to change the lives of millions living with dry AMD, and we are confident that Alcon has the capabilities to broadly commercialize it.'

“我们非常高兴爱尔康认同该设备改变数百万干性AMD患者生活的潜力，并且我们相信爱尔康有能力将其广泛商业化。”

Intended Use and Patient Population

预期用途和患者人群

The PBM technology is intended to improve visual acuity in patients with best-corrected visual acuity ranging from 20/32 to 20/70 who have dry age-related macular degeneration (AMD) characterized by the presence of at least three medium drusen (greater than 63 μm and up to 125 μm in diameter), large drusen (greater than 125 μm in diameter), or non-central geographic atrophy, and who do not have neovascular maculopathy or central-involving geographic atrophy..

PBM技术旨在改善最佳矫正视力在20/32至20/70范围内的干性年龄相关性黄斑变性（AMD）患者的视力，这些患者具有至少三个中等大小的玻璃膜疣（直径大于63微米且不超过125微米）、大玻璃膜疣（直径大于125微米）或非中央地理萎缩，并且没有新生血管性黄斑病变或中央涉及的地理萎缩。

Transaction Details and Exclusions

交易明细和排除项

The acquisition does not include LumiThera’s AdaptDx and Nova/Diopsys diagnostic devices, which will be separated and spun off to LumiThera shareholders prior to the acquisition. These diagnostic products will continue to be marketed and sold by the LumiThera spin-off.

收购不包括LumiThera的AdaptDx和Nova/Diopsys诊断设备，这些设备将在收购前被分离并分拆给LumiThera股东。这些诊断产品将继续由LumiThera分拆出来的公司进行市场推广和销售。

Alcon and LumiThera expect the transaction to close in the third quarter of 2025, pending customary closing conditions and a vote by LumiThera shareholders.

爱尔康和LumiThera预计，此项交易将在2025年第三季度完成，前提是满足惯例的交割条件并获得LumiThera股东的投票批准。

Reference:

参考：

https://www.alcon.com/media-release/alcon-acquire-lumithera-and-its-photobiomodulation-device-treatment-early-and/

https://www.alcon.com/media-release/alcon-acquire-lumithera-and-its-photobiomodulation-device-treatment-early-and/