FDA Authorizes LumiThera’s Valeda Light Delivery System for Dry AMD Treatment

FDA Authorization:
The FDA has granted authorization to LumiThera to market its Valeda Light Delivery System for the treatment of dry age-related macular degeneration (AMD).

First Treatment for Dry AMD:
Valeda is the first FDA-authorized treatment for vision loss in dry AMD patients, providing an improvement in best corrected visual acuity (BCVA) over 24 months of >5 letters or equivalent to a line on the eye chart.

De Novo Request:
LumiThera submitted the US LIGHTSITE III clinical data under a De Novo request with special controls, which was approved by the FDA.

Clinical Benefits:
The LIGHTSITE III trial demonstrated clinical benefits in early to intermediate dry AMD patients out to 24 months with an excellent safety profile.

Non-Invasive Treatment:
Valeda is a non-invasive, multiwavelength photobiomodulation device that can help improve vision and address the disease earlier, before permanent vision loss.

Availability:
Valeda is now available in the U.S. for dry AMD patients, in addition to its existing availability in Europe and select countries in Latin America.