LumiThera Inc. announced the FDA has authorized marketing of the company's Valeda Light Delivery System for the treatment of patients with dry AMD.

The Valeda therapy is the first ever authorized treatment by the FDA for vision loss in dry AMD patients, the company said in a press release. Valeda provides an improvement in BCVA over 24 months of >5 letters or equivalent to a line on the eye chart. In the pivotal US LIGHTSITE III trial, the Valeda treatment met its primary endpoint and was shown to be safe and effective in increasing and maintaining improved visual acuity, the company said.

LumiThera submitted the LIGHTSITE III clinical data as part of a technical package to the FDA under a de novo request with special controls.

“We have been working hard to bring Valeda, a multiwavelength photobiomodulation device to our US patients for several years," stated Clark Tedford, Ph.D., president and CEO, in the press release. "We now have a non-invasive treatment option for dry AMD patients that may improve vision and address the disease earlier, before permanent vision loss. The FDA authorization of the Valeda treatment to improve vision in dry AMD now provides a significant option for our US patients."