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Promising Anatomic Outcomes from the LIGHTSITE III Trial

Diana V. Do, MD, and Glenn J. Jaffe, MD

Diana V. Do, MD, and Glenn J. Jaffe, MD, discuss key anatomic findings from the LIGHTSITE III clinical trial evaluating photobiomodulation (PBM) with the FDA-authorized Valeda® Light Delivery System (LumiThera, Inc.) to treat dry age-related macular degeneration (AMD). Drs. Do and Jaffe share their observations of the data, citing a decrease in the proportion of eyes that developed geographic atrophy and a reduction of drusen volume.

Valeda Demonstrates Vision Improvement in Patients with Dry AMD

Diana V. Do, MD, and Glenn J. Jaffe, MD

Diana V. Do, MD, and Glenn J. Jaffe, MD, discuss the efficacy and safety outcomes from the LIGHTSITE III clinical trial evaluating the Valeda® Light Delivery System for the treatment of dry age-related macular degeneration (AMD). Dr. Do shares key results from the study, emphasizing how the trial successfully met its primary visual acuity endpoints. Valeda® Light Delivery System is FDA-Authorized, CE-Marked, UKCA-Marked, and commercially available in select countries across Latin America.

Safety and Efficacy Results from LIGHTSITE III Trial for Dry AMD

David S. Boyer, MD; and Marion R. Munk, MD, PhD

David S. Boyer, MD, and Marion R. Munk, MD, PhD, discuss pivotal findings from the LIGHTSITE III clinical trial in patients with dry age-related macular degeneration (AMD). Dr. Boyer underscores the potential of this innovative treatment to deliver meaningful clinical benefits, emphasizing its favorable safety profile. Dr. Munk offers a comprehensive review of the study design and parameters, providing valuable context and interpretation of the trial’s outcomes. Valeda® Light Delivery System is FDA-Authorized, CE-Marked, UKCA-Marked, and commercially available in select countries across Latin America.

Month 24 Clinical Trial Results in Dry AMD Patients

Eleonora Lad, MD, and Victor Gonzalez, MD

Eleonora, MD, and Victor Gonzalez, MD, discuss key outcomes from the LIGHTSITE III clinical trial evaluating photobiomodulation therapy with the Valeda® Light Delivery System. Dr. Lad highlights that the study met its primary endpoint, showing a statistically significant improvement in BCVA. Dr. Gonzalez emphasizes the reduction in new geographic atrophy development, suggesting Valeda’s potential in managing dry AMD as a chronic, progressive disease.

Patient Brochures

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 {> 125μm 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.

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.

Refer to the Valeda Light Delivery System User Manual for full Important Safety Information.

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