Valeda Light Delivery System

The Valeda Light Delivery System is the first and only FDA-authorized medical device utilizing multiwavelength photobiomodulation (PBM) to treat vision loss in patients with early and intermediate dry age-related macular degeneration (AMD). Originally developed by LumiThera, Inc. and later acquired by Alcon, it uses low-level light therapy to stimulate mitochondrial activity, improve cellular energy production, and help slow the progression of retinal cell damage.

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Device Summary & Mechanism of Action

Valeda functions as a non-invasive, benchtop instrument that delivers a targeted sequence of eye-safe, non-coherent light across three distinct wavelengths to "recharge" retinal cells.

The standard protocol involves a completely painless, injection-free, and dilation-free series of 9 sessions per eye over 3 to 5 weeks, typically repeated every 4 to 6 months to maintain visual acuity. Eligible candidates are adults with best-corrected visual acuity (BCVA) between 20/32 and 20/70 experiencing early-to-intermediate dry AMD with drusen deposits.

Clinical Statistics & Efficacy

Data from the landmark LIGHTSITE III clinical trial provided the primary empirical basis for the device's therapeutic claims:

Vision Maintenance: 84% of Valeda-treated patients improved or maintained their vision at approximately 2 years compared to baseline.
Visual Acuity Gain: Over 60% of patients experienced a ≥1-line improvement in visual acuity (~5 letters on a standard ETDRS eye chart) at the 2-year mark.
Anatomical Benefits: The treatment demonstrated a statistically significant decrease in new-onset geographic atrophy (advanced tissue loss) compared to a sham control group.
Safety Profile: There were 0 reports of phototoxicity or serious eye-pain adverse events across the multi-year clinical trial portfolio.

Development History & Commercialization Timeline

The regulatory and market expansion of Valeda progressed through several critical milestones:

Initial Development: LumiThera developed the Valeda system and validated its safety and efficacy through the prospective LIGHTSITE I, II, and III clinical programs.
FDA De Novo Authorization: In November 2024, the US FDA granted De Novo marketing authorization to the Valeda Light Delivery System, establishing it as the first authorized therapeutic light device for dry AMD in the United States.
Global Access: Concurrently, the system received a CE Mark in Europe and gained commercial clearance across the United Kingdom, Singapore, and various Latin American markets (such as Colombia and Chile).
Alcon Acquisition: In September 2025, global eye care leader Alcon completed its strategic acquisition of LumiThera Inc., absorbing the Valeda technology into its permanent vitreoretinal portfolio to scale its manufacturing, distribution, and upcoming regulatory pathways globally.

Protect Your Vision with Valdea

Discover the power of the first and only FDA-authorized multiwavelength light therapy—contact us today to learn more about what Valeda can do for you.

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