Valeda PBM: Evidence, Safety & Specs

What is the Valeda PBM?

Valeda PBM, which Alcon also calls the Valeda Light Delivery System, is an in-office device. You sit at the device while it delivers low-level light to the eye, without contact, dilation or injection. It is used in eye care clinics, not at home.

It is for the dry form of AMD, the most common type. Wet AMD is treated differently, usually with injections.

How it works

Alcon’s page says mitochondrial dysfunction contributes to vision loss in dry AMD. Its three wavelengths, 590, 660 and 850 nm, are said to target cytochrome c oxidase, an enzyme that supports the cell’s energy (ATP) production. This is the photobiomodulation principle described on our Vielight and Wellscare pages. Alcon also says benefit may not last after treatment stops, and that there are no data for more frequent dosing or more than 54 treatments per eye.

590nm

Yellow

Alcon says this wavelength increases nitric oxide synthesis and widens blood vessels (vasodilation), which may improve oxygen and nutrient delivery in the eye.

660nm

Red

Alcon says this wavelength promotes oxygen binding at cytochrome c oxidase, stimulates ATP (cell energy) production, and reduces inflammation and cell death.

850nm

Near-infrared

Alcon says this wavelength drives electron transfer in cytochrome c oxidase, stimulates ATP production, and reduces inflammation and cell death.

For the history and science of red and near-infrared light, see our book The Accidental Discovery of Redlight Therapy.

What the research shows

54
applications, in 6 courses over 2 years: 98
patients (145 eyes) in LIGHTSITE III: 84%
of treated patients maintained or improved vision at about 2 years: 0
reports of phototoxicity across 3 LIGHTSITE trials

These figures are reported by Alcon on its professional site. The 84% figure describes the Valeda group alone and is not a comparison with sham treatment. Our page below explains what the trial did and did not show.

The LIGHTSITE III trial was a 24-month, prospective, randomized, double-masked, sham-controlled study of 98 patients (145 eyes) aged 50 or older with dry AMD. Randomization was 2:1 to Valeda or sham.

Alcon reports that the primary efficacy endpoint was met at Month 21. Its headline figures for treated patients (84% maintained or improved vision at about two years, and more than 60% gained at least one line) describe the Valeda group alone, and the page does not compare them with sham.

In the early AMD subgroup, Alcon reports the difference from sham in mean best-corrected visual acuity (BCVA) as +1.90 letters at Month 13, −0.10 at Month 21 and +0.29 at Month 24. The benefit did not hold at Month 21, so this subgroup result is weak.

Alcon’s indication text claims about one line of improved visual acuity after about two years, compared with untreated patients. We have not checked this against the trial publication.

The trial was sponsored by the device’s manufacturer. Treatment is a course over two years, and the benefit may not last once treatment stops.

Who it is for

Adults with dry AMD who meet Alcon’s criteria: best-corrected visual acuity of about 20/32 to 20/70, and dry AMD with specified drusen or non-central geographic atrophy (GA), confirmed by an eye care professional.

Not for people with neovascular (wet) AMD, or with center-involving GA in the central 1 mm. It is not a screening tool.

Safety

Contraindications on Alcon’s page: known photosensitivity to yellow, red or near-infrared light; a history of light-activated CNS disorders such as epilepsy or migraine; and photosensitizing medicines that act at 590, 660 or 850 nm within 30 days, unless a physician clears them.

Alcon lists these as not established: patients under 50, pregnant or nursing women, a history of neovascular maculopathy, center-involving GA in the central 1 mm, and cataracts or other media opacities that obscure the view.

Alcon reports no phototoxicity and no serious adverse events related to Valeda across three LIGHTSITE trials. In LIGHTSITE III, 12 treated fellow eyes (12.9%) and 4 sham fellow eyes (7.3%) had neovascular AMD. Of these, 5 of 12 treated eyes (41.7%) converted to neovascular AMD, compared with 1 of 4 sham eyes (25.0%). Alcon advises close monitoring.

Be careful with unproven alternatives: three women lost vision after unapproved “stem cell” eye injections for macular degeneration at a U.S. clinic. See our stem cell cost and evidence guide.

Questions

Is Valeda FDA approved?

The FDA authorized Valeda through De Novo marketing authorization in November 2024, for patients with dry AMD. Alcon describes it as the first and only FDA-authorized treatment for dry AMD to improve and maintain vision for up to 2 years.

Who makes Valeda now?

Alcon. It completed its acquisition of LumiThera, the company that developed the device, in 2025. The device is now sold as Valeda PBM.

Is Valeda available in Canada?

We found no Health Canada authorization and no Canadian availability on Alcon’s site or in the acquisition coverage. Alcon says it plans to expand into more countries from 2026, pending regulatory approvals. Ask your optometrist or ophthalmologist.

Can supplements help dry AMD?

The AREDS2 formula (vitamins C and E, zinc, copper, lutein and zeaxanthin) is the established supplement for intermediate AMD. Ask your eye doctor before starting it.

Sources

Vanu Health does not sell this device and is not paid by its maker. General information, not medical advice. Read our terms.