- Transaction brings Alcon the Valeda PBM device, the only technology that provides one line of visual improvement in dry AMD patients* undergoing two years of treatments**1,2
- Acquisition builds on Alcon leadership in surgical retina, expanding its footprint in the clinic and entering dry AMD
- Alcon to begin selling Valeda PBM device in approved markets generating revenue this year, with plans to expand into additional countries in 2026
Alcon announced that it has completed its acquisition of LumiThera, Inc., 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 Oofficer 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.
About Valeda PBM
Valeda PBM multiwavelength treatments are for patients suffering from dry AMD. The Food & Drug Administration (FDA) has authorized marketing of the PBM device treatment for dry AMD patients to improve vision.
Important product information
indications for use
The Valeda Light Delivery System is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 and who have dry age-related macular degeneration (AMD) characterized by:
- The presence of at least 3 medium drusen (> 63 μm and = 125 μm in diameter), or large drusen (> 125 μm in diameter), or non-central geographic atrophy, AND
- The absence of neovascular maculopathy or central-involving geographic atrophy
After about two years, the Valeda Light Delivery System treatment provides improved mean visual acuity of approximately one line of visual acuity (ETDRS) compared to those not receiving the treatment.
Contraindications for use
As a precaution, patients have not been tested and should not be treated with Valeda if they have any known photosensitivity to yellow light, red light, or near-infrared radiation (NIR), or if they have a history of light-activated central nervous system disorders (e.g., epilepsy, migraine). In addition, patients should not receive treatment within 30 days of using photosensitizing agents (e.g., topicals, injectables) that are affected by 590, 660, and/or 850 nm light before consulting with their physician.
Precautions
It is possible that treatment benefit may not persist significantly after treatment is stopped. The clinical study provided no significant data concerning the safety and effectiveness of the device should treatments be applied more frequently than described in this manual, or if more than 54 total treatments are delivered per eye.