Alcon to Acquire LumiThera and Its FDA-Authorized PBM Device for Dry AMD

Alcon has announced its plan to acquire LumiThera, Inc., a company that developed a photobiomodulation (PBM) device for treating early and intermediate stages of dry age-related macular degeneration (AMD). This transaction, expected to close by the third quarter of 2025, will not include LumiThera’s vision testing and diagnostic products, AdaptDx and Diopsys Nova, which are set to be spun off into a new entity owned by LumiThera’s shareholders.
Dry AMD is a progressive retinal disease without a cure and is recognized as a leading cause of blindness. It affects close to 200 million individuals globally, based on estimates provided by Alcon. The disease impairs central vision through damage to the macula, an area of the retina essential for detailed vision. Mitochondrial dysfunction in retinal cells is one of the contributing factors to vision loss in dry AMD.

LumiThera’s Valeda system utilizes PBM, a technique involving low-level light delivered through three specific wavelengths. These wavelengths are designed to stimulate mitochondrial activity and enhance retinal cellular function. Unlike laser therapies, the Valeda system delivers non-phototoxic light and is administered to patients in a clinical setting.
In November 2024, the U.S. Food and Drug Administration granted de novo market authorization for the Valeda system, recognizing it as the first approved therapy in the U.S. for dry AMD. The system had earlier received CE Mark certification in Europe in 2018 and is also available in Latin America, Singapore, and the United Kingdom.
The clinical performance of PBM has been evaluated across multiple studies, including the LIGHTSITE I, II, and III trials. The LIGHTSITE III pivotal trial, conducted at 10 U.S. locations, assessed the effects of PBM over two years compared to a control group receiving standard light therapy. Findings indicated that patients treated with PBM, on average, gained one line of visual acuity (ETDRS scale) at months 13, 21, and 24. In addition, 88% of treated individuals maintained or improved their vision from baseline, while 64% experienced visual gains of at least one line. More than 97% of patients reported no discomfort, and over 80% completed the full recommended two-year treatment course.

Extended results from an open-label follow-up study published in May showed that after a 20-month pause, patients retained some of the earlier vision improvements and regained vision once again following a 13-month retreatment period.
Alcon’s Vice President and General Manager of its global surgical franchise, Sean Clark, commented, “Dry AMD is an area of significant unmet need, and PBM is an efficacious, non-invasive light therapy that can provide visual improvement for patients with early and intermediate disease.”
LumiThera President and CEO, Clark Tedford, also stated, “Our PBM device provides a non-invasive treatment for dry AMD patients that can improve vision and address the disease earlier, before permanent vision loss.”
The financial terms of the acquisition were not disclosed. This move follows Alcon’s recent activity in expanding its portfolio through other acquisitions, including deals for laser-based systems such as Belkin Vision’s automated glaucoma platform and Lensar’s Ally robotic cataract surgery system.