Alcon announced that it has completed its acquisition of LumiThera, a leader in light-based innovations for ophthalmology. The acquisition includes the noninvasive Valeda photobiomodulation (PBM) device for the treatment of early and intermediate dry age-related macular degeneration (AMD), and a sub-set of late dry AMD (non-central involving geographic atrophy).*1 Dry AMD is a progressive disease typically treated in late stage, with limited treatment options.2 On average, Valeda PBM patients experience visual acuity improvement—gaining one line of visual acuity (ETDRS) compared to baseline, with two years of treatments.**3
“Since Alcon entered the retina space in 1997, we’ve focused our efforts mainly in surgical, delivering leading products and solutions for the operating room. As we welcome LumiThera and Valeda PBM to Alcon, we move into the retina clinic and the dry AMD space,” said Ian Bell, SVP, Chief Operating Officer of Alcon. “We look forward to broadening access and availability to Valeda PBM so more dry AMD patients can benefit from early intervention.”
Valeda PBM delivers non-phototoxic light therapy using three wavelengths that have demonstrated safety and efficacy in patients with dry AMD.*4,5 Data from the LIGHTSITE I, II and III clinical trials consistently demonstrate visual acuity improvement with Valeda PBM, without causing any discomfort in 97% of patients.2,3
“The vision gains demonstrated by Valeda PBM in the multi-center randomized, actively controlled LIGHTSITE clinical trials usher in a new era for the approach to treat dry AMD,” said Allen C. Ho, MD, FACS, FASRS, Director of Retina Research at Wills Eye Hospital and Chairman of the Alcon Research Institute (ARI) Executive Committee. “Treating dry AMD earlier—before the development of advanced disease—has always made sense, but we did not have technology that could improve vision until the introduction of Valeda PBM. Alcon has been a successful, dedicated partner to the retina ecosystem and this instills confidence that clinic-based Valeda PBM can reach the dry AMD* patients who may benefit from this therapy.”
Valeda PBM is currently available in the U.S., and several countries in Europe and Latin America. Alcon aims to expand Valeda PBM office-based treatment in approved markets, underscoring its commitment to people living with retinal diseases. Pending regulatory approvals, Alcon plans to expand Valeda PBM into additional markets, beginning in 2026. For more information, please visit myValeda.com
*Dry AMD eyes with: 3 medium drusen, or 1 large drusen, or non-central involving GA; and with BCVA between 20/32 – 20/70 (i.e., early and intermediate dry AMD, and a sub-set of late dry AMD).
**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. Valeda® Light Delivery System User Manual (LBL-0001-01 REV C).
4. 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.
5. 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.