FDA Authorizes Photobiomodulation for Dry AMD

Overview

In November 2024 the U.S. Food and Drug Administration authorized marketing of LumiThera’s Valeda Light Delivery System, the first photobiomodulation treatment cleared in the United States for non-neovascular (dry) age-related macular degeneration. The decision followed the pivotal LIGHTSITE III randomized trial and has since been reinforced by a strategic acquisition that puts more distribution muscle behind the therapy. 

How Valeda photobiomodulation works

Photobiomodulation (PBM) uses specific red and near-infrared wavelengths to modulate mitochondrial activity and cellular signaling. In the retina the goal is to support photoreceptors and retinal pigment epithelium function to preserve or improve vision. 

What the clinical evidence shows

LIGHTSITE III met its primary end point, demonstrating a statistically significant improvement in best-corrected visual acuity versus sham at 13 months, with benefits maintained in long-term follow up that was part of the FDA submission. 

“The RCT results demonstrated clinical benefits in early to intermediate dry AMD patients out to 24 months and an excellent safety profile,” said David Boyer, MD. 

Glenn Jaffe, MD, noted additional anatomic signals that the team followed longitudinally.

“We looked at whether PBM affected progression to geographic atrophy and found that incident geographic atrophy was reduced in the PBM-treated eyes compared to the sham treated eyes.” 

Access and availability

In September 2025 Alcon announced it had completed the acquisition of LumiThera, positioning the Valeda system for expanded rollout through Alcon’s eye-care network. 

Safety and limitations

A JAMA Ophthalmology Viewpoint highlights enthusiasm and also calls for careful interpretation of trial protocols and endpoints. Clinicians should set expectations and assess candidacy on an individual basis. 

Who may be a candidate

• Adults with early to intermediate dry AMD and measurable vision loss

• Patients seeking a non-invasive, office-based option that aims to improve visual function

  Eligibility and retreatment schedules are determined by retina specialists. 

Key takeaways

• First FDA-authorized PBM for dry AMD, supported by an RCT

• Distribution likely to expand following Alcon’s acquisition

• Ongoing discussion in the literature about long-term disease modification