Valeda is the only PBM device to be granted FDA de Novo authorization for medical claims associated with the treatment of dry age-related macular degeneration (AMD)

  • Valeda is a medical device designed for ease of use in the clinician’s office
  • Treatments are delivered in a series of 9 sessions per eye over a three-five-week period

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 center-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 haveany known photosensitivity to yellow light, red light or near-infrared radiation (NIR), or if they have ahistory 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.

Refer to Valeda User Manual for the full Important Safety Information

How Valeda Works

Valeda uses light-emitting diodes (LEDs) to stimulate cellular function, leading to improved energy production within the mitochondria.

Valeda delivers wavelengths of 590, 660, and 850 nm. In the scientific literature, these wavelengths address independent cellular mechanisms that are important in age-related macular degeneration.

Both the 660 and 850 nm wavelengths were chosen based on their known interaction with cellular photoacceptors in cytochrome c oxidase (CCO). The 660 and 850 nm wavelengths promote electron transfer and oxygen binding, respectively, in CCO leading to restoration of mitochondria function and increases in metabolic activity (i.e., energy production), and inhibition in inflammatory events and cell death.

The 590 nm wavelength increases the signaling protein nitric oxide which reduces oxidative stress-mediated injury in the cell and increases O2 delivery.

  • Wavelength 8501
    Drives electron transfer (CUA) stimulates metababolic activity (ATP) and inhibits inflammation and cell death
  • Wavelength 6601
    Promotes O2 binding (CUB), stimulates metababolic activity (ATP) and inhibits inflammation and cell death
  • Wavelength 5902
    inhibits VEGF expression and promotes nitric oxide generation
1. Wong-Riley MTT, et al. J Biol Chem. 2005; 280: 4761-71;
2. Ball KA, et al. J Photochem Photobiol B Biol, 2012; 102: 182-91.