Alcon Expands into AMD Treatment

According to a press statement issued by Alcon, LumiThera’s PBM is the only device that has demonstrated meaningful vision improvement compared to baseline for people living with early to intermediate dry AMD.^2,* Dry AMD is a progressive disease typically treated in late stage, with limited treatment options.²

LumiThera’s PBM is the only device that has demonstrated meaningful vision improvement compared to baseline for people living with early to intermediate dry AMD

“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. “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.”

Stimulating Mitochondrial Energy

In dry AMD, vision loss results from the dysfunction and break down of retinal cells within the macula.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 three 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 U.S. and evaluated two years of PBM treatment versus a control light therapy. 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 24, ⁹
• About 88% of patients in the PBM group maintained or gained vision versus Baseline at Month 24, ⁹
• 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 24, ⁹
• More than 97% of patients reported no pain or discomfort, ^2,9
• More than 80% of patients stayed on therapy for two years – the recommended course of treatment. ^2,9

PBM received FDA de novo market authorisation 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.

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.

References

1. US Food and Drug Administration. De Novo classification request for Valeda Light Delivery System (DEN230083). Accessed June 2025. Available  at 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).