GENEVA — Alcon announced plans to acquire LumiThera, Inc., bringing under its umbrella a novel photobiomodulation (PBM) device used to treat early and intermediate dry age-related macular degeneration (AMD), a leading cause of vision loss worldwide.
PBM is a non-invasive light therapy that uses specific wavelengths to stimulate mitochondrial function in retinal cells. Clinical data from three separate trials, including the pivotal LIGHTSITE III study, have shown that the therapy can improve visual acuity and maintain vision over a two-year period in patients with early-stage dry AMD. No serious adverse events were reported in the studies.
“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,” said Sean Clark, Vice President and General Manager of Alcon’s Global Surgical Franchise. “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.”
Dry AMD affects nearly 200 million people worldwide and has no cure. The disease causes progressive damage to the macula, the central part of the retina responsible for sharp vision. As the condition advances, patients may lose the ability to read, drive, or recognize faces.
The PBM technology developed by LumiThera targets mitochondrial dysfunction, a known contributor to vision loss in dry AMD. Using three science-backed wavelengths, the treatment is delivered without lasers, pain, or discomfort, and is administered in a clinic setting.
The LIGHTSITE III trial, conducted across 10 U.S. sites, showed that patients treated with PBM experienced sustained improvements in visual acuity, with 64% gaining at least one line on the ETDRS chart by Month 24. Additionally, 88% of treated patients either maintained or improved their vision, and 80% remained on therapy for the full two-year course.
“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,” said Clark Tedford, Ph.D., President and CEO of LumiThera. “We are thrilled that Alcon agrees in the potential that this device has to change the lives of millions living with dry AMD.”
The PBM device received FDA de novo market authorization in November 2024 and was granted CE Mark in Europe in 2018. It is currently available in Europe, Latin America, the U.K., Singapore, and the U.S.
The acquisition, expected to close in the third quarter of 2025, does not include LumiThera’s diagnostic platforms AdaptDx and Nova/Diopsys, which will be spun off into a separate company and continue to operate independently. Completion of the deal is subject to standard closing conditions and a shareholder vote.
