FDA

Innovative light therapy device gains FDA approval for dry AMD

November 11, 2024

FDA authorized the marketing of LumiThera, Inc.’s Valeda Light Delivery System to improve vision in certain patients with dry age-related macular degeneration (AMD), a leading cause of central vision loss in adults >55 years in developed countries. The device, which uses three light-emitting diodes at different wavelengths, can improve best corrected visual acuity over 24 months by >5 letters or equivalent to a line on the eye chart. In the LIGHTSITE III trial, the Valeda treatment met its primary endpoint, visual acuity gain, and was shown to be safe and effective in increasing and maintaining improved visual acuity.

Sources:

FDA. (2024, November 5). FDA Roundup: November 5, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-november-5-2024

LumiThera. (2024, November 4). LumiThera Obtains FDA Authorization of Valeda Treatment for Dry AMD Patients to Improve Vision. [Press release]. https://www.lumithera.com/lumithera-obtains-fda-authorization-of-valeda-treatment-for-dry-amd-patients-to-improve-vision/