Alcon to Acquire LumiThera and Its PBM Device for Dry AMD

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.

Valeda: PBM Device with Clinical Evidence Supporting Vision Improvement

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

“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.”

How PBM Works

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.

Clinical Evidence Supporting PBM

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:

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

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

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

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

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

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

“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."

Intended Use and Patient Population

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.

Transaction Details and Exclusions

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.

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

Reference:

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