The US Food and Drug Administration (FDA) has authorized LumiThera to market its Valeda Light Delivery System for the treatment of patients with dry age-related macular degeneration (AMD), the company said in a press release.

The Valeda photobiomodulation (PBM) therapy is the first FDA-authorized treatment for vision loss in dry AMD patients, the company said. In the pivotal phase 3 LIGHTSITE III trial (NCT04065490), the Valeda treatment met its primary endpoint and was shown to be safe and effective in increasing and maintaining improved visual acuity. Valeda showed an improvement in best-corrected visual acuity (BCVA) over 24 months of >5 EDTRS letters, equivalent to a line on the eye chart.

The Valeda Light Delivery System has already received the CE Mark in Europe and is available in select countries in Latin America. LumiThera recently launched a new clinical registry study, EUROLIGHT, which will collect outcome data from 500 to 1,000 patients treated with  photobiomodulation therapy.