Alcon announced in a press release its intention to acquire LumiThera, Inc and Valeda Light Delivery System photobiomodulation (PBM) device for the treatment of early and intermediate dry AMD.¹ LumiThera’s PBM has demonstrated meaningful vision improvement compared to baseline for people living with early to intermediate dry AMD.²* 

Nearly 200 million people globally live with dry AMD, a progressive disease with no cure, and a leading cause of blindness in developed nations.^3,4 In dry AMD, vision loss results from the dysfunction and break down of retinal cells within the macula—the part of the retina that allows for sharpness and fine detail in seeing what’s directly in front of the viewer.⁴ In the early stages, central vision becomes distorted and may ultimately progress to a complete loss, making everyday activities difficult, like reading, driving and even recognizing faces.⁵

The retina is rich in mitochondria, and mitochondrial dysfunction is a known cause of vision loss in dry AMD.⁶ PBM uses low-level light to stimulate mitochondrial energy production, promoting retinal cellular health. It uses 3 specific, science-backed wavelengths—delivering non-phototoxic light therapy (not laser therapy).^7,8 The non-invasive treatments are administered while the patient is sitting comfortably in a clinic setting.

Data from the LIGHTSITE I, II, and III clinical trials consistently showed that PBM treatments provide visual acuity improvement with no treatment-related serious adverse events reported.² The pivotal LIGHTSITE III study was conducted at 10 sites across the United States and evaluated 2 years of PBM treatment vs a control light therapy. The results showed:

• Patients with PBM-treated eyes on average experienced visual acuity improvement—gaining 1 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 vs Baseline at Month 24⁹

• Nearly two-thirds of patients (64%) with PBM-treated eyes experienced visual acuity improvement—gaining at least 1 line of visual acuity (ETDRS) from Baseline at Month 24⁹

• More than 97% of patients reported no pain or discomfort^2,9

• More than 80% of patients stayed on therapy for 2 years—the recommended course of treatment^2,9

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 United Kingdom and the United States.

According to the press release, 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.

“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,” said Sean Clark, vice president and general manager, Global Surgical Franchise, Alcon, in the press release. “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 eyecare professionals and their patients, while continuing to strengthen its body of clinical evidence.”

Also commenting on the acquisition, Clark Tedford, PhD, president and CEO of LumiThera, added: “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.”

*It is possible that treatment benefit may not persist significantly after treatment is stopped.

References

1. U.S. Food and Drug Administration. De Novo classification request for Valeda Light Delivery System (DEN230083). Accessed June 2025 at https://www.accessdata.fda.gov/cdrh_docs/pdf23/DEN230083.pdf.

2. LumiThera, Inc. A double-masked, randomized, sham-controlled, parallel group, multi-center study to assess the safety and efficacy of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) (LIGHTSITE III). Clinical Study Report CSP005.

3. Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health. 2014;2(2):e106–e116. DOI: 10.1016/S2214-109X(13)70145-170145-1.

4. Centers for Disease Control and Prevention. About Common Eye Disorders and Diseases. Accessed in June 2025 at www.cdc.gov/vision-health/about-eye-disorders/index.html.

5. Mitchell P, Liew G, Gopinath B, Wong TY. Age-related macular degeneration. The Lancet. 2018;392(10153):1147–1159. DOI: 10.1016/S0140-6736(18)31550-2.

6. Eells JT. Mitochondrial dysfunction in the aging retina. Biology (Basel). 2019;8(2):31. DOI: 10.3390/biology8020031.

7. Wong-Riley MTT, Liang HL, Eells JT, Chance B. Photobiomodulation directly benefits primary neurons functionally inactivated by toxins: Role of cytochrome c oxidase. J Biol Chem. 2005;280(6):4761–4771. DOI: 10.1074/jbc.M409650200.

8. Ball KA, Castello PR, Poyton RO. Low intensity light stimulates nitrite-dependent nitric oxide synthesis but not oxygen consumption by cytochrome c oxidase: Implications for phototherapy. Biochim Biophys Acta. 2011;1807(7):964–970. DOI: 10.1016/j.bbabio.2011.04.003.

9. Valeda Light Delivery System User Manual (LBL-0001-01 REV C).