First FDA Approved Treatment for Dry Macular Degeneration

The future for AMD treatment is a little brighter with the approval of LumiThera's Valeda system. 

This is the first light-based therapy for dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 65. Dry AMD results from the gradual loss of photoreceptor cells in the retina’s macula, leading to cloudy or obstructed central vision. Left untreated, around 10% of dry AMD cases progress to wet AMD, marked by abnormal blood vessel growth at the back of the eye.

Valeda uses photobiomodulation—a treatment that applies different light wavelengths to stimulate cellular activity, particularly in the mitochondria, the cell’s energy center. This technique aims to enhance cell metabolism and proliferation, which could help slow or reverse retinal degeneration. In a controlled clinical trial, Valeda demonstrated measurable improvements in visual acuity after two years of treatment, allowing some patients to read an extra line on the standard eye chart.

The FDA’s clearance marks a significant step as it introduces a non-invasive option for dry AMD patients in the U.S., a group estimated at 20 million in 2019, with projections suggesting a global rise to 240 million by 2030. Previously, the Valeda system was available in Europe after obtaining a CE mark, and LumiThera has now succeeded in bringing it to the U.S. market, giving patients an earlier treatment opportunity to potentially improve vision before permanent loss occurs.

What is Photobiomodulation?

Photobiomodulation (PBM) is a therapeutic technique using specific light wavelengths to stimulate biological processes in cells. By directing light energy at cellular mitochondria, PBM increases energy production, promoting higher metabolism, cellular repair, and growth. For dry AMD, PBM stimulates retinal cells to potentially slow degeneration and improve vision. The Valeda device uses multiple wavelengths to achieve this cellular stimulation, supporting the health of retinal tissue and, in turn, visual function.

This a great first step in the treatment of dry AMD and it is comforting to know that progress (albeit slow progress) is being made.

Find the press release here: https://www.fiercebiotech.com/medtech/fda-clears-first-treatment-dry-amd-lumitheras-light-based-valeda-system