Alcon, a leader in eye care, plans to acquire LumiThera, an innovator in light-based therapies for ophthalmology, along with its PBM device for treating early and intermediate dry age-related macular degeneration (AMD).
LumiThera’s PBM is notable for demonstrating significant vision improvement in individuals with early to intermediate dry AMD, a progressive disease that typically has limited treatment options until later stages.
Dry age-related macular degeneration (AMD) causes vision loss by breaking down retinal cells in the macula, which is crucial for sharp, detailed vision. Early symptoms include distorted central vision, which can progress to complete loss, affecting daily activities such as reading and driving.
Mitochondrial dysfunction in the retina is a known factor in dry AMD. Photobiomodulation (PBM) therapy utilizes low-level, non-phototoxic light to enhance mitochondrial energy production and promote the health of retinal cells. This non-invasive treatment is administered in a comfortable clinic setting.
Clinical trials, including LIGHTSITE I, II, and III, demonstrate that PBM treatments enhance visual acuity without significant adverse events. The LIGHTSITE III study compared two years of PBM therapy with a control light therapy across ten sites in the U.S.
The results showed:
— Patients with PBM-treated eyes on average experienced visual acuity improvement—gaining one line of visual acuity (ETDRS) from Baseline at Months 13, 21 and maintained at Month 249
— About 88% of patients in the PBM group maintained or gained vision versus Baseline at Month 249
— Nearly two-thirds of patients (64%) with PBM-treated eyes experienced visual acuity improvement—gaining at least one line of visual acuity (ETDRS) from Baseline at Month 249
— More than 97% of patients reported no pain or discomfort2,9
— More than 80% of patients stayed on therapy for two years—the recommended course of treatment2,9
PBM received FDA de novo market authorization in November 2024 and received CE Mark in November 2018. PBM is currently available in Europe, Latin America, Singapore, the U.K. and the U.S.
The transaction does not include the acquisition of AdaptDx and Nova/Diopsys diagnostic devices, which will be separated and spun off to LumiThera’s shareholders prior to Alcon’s acquisition and will continue to be marketed and sold by the LumiThera spin-off. Subject to customary closing conditions and a LumiThera shareholder vote, Alcon and LumiThera anticipate the acquisition to be completed in the third quarter of 2025.
KEY QUOTES:
“For more than 25 years, Alcon has been a leader in vitreoretinal surgery, and we are excited to expand our offerings into the clinic, to help millions of people living with dry AMD gain vision. 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. 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.”
Sean Clark, Vice President and General Manager, Global Surgical Franchise, Alcon
“At LumiThera, we have been committed to developing novel light therapy technologies that address dry AMD. 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. 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.”
Clark Tedford, Ph.D., President and CEO of LumiThera
