The FDA granted de novo marketing authorization Valeda Light Delivery System for the treatment of dry age-related macular degeneration, according to a press release from LumiThera.
The ruling is supported by data from the pivotal LIGHTSITE III trial, in which Valeda demonstrated safety and efficacy in maintaining visual acuity and met its primary endpoint.
“Valeda is the first and only FDA-authorized treatment for dry AMD,” Clark Tedford, PhD, LumiThera president and CEO, told Healio. “Valeda improves and maintains visual acuity out to 24 months with repeat treatments as