LumiThera Obtains FDA Authorization of Valeda Treatment for Dry AMD

The FDA has granted authorization to LumiThera allowing the company to market its Valeda Light Delivery System. This approval, made under the De Novo authorization pathway, makes Valeda the first FDA-authorized device to treat vision loss in patients with dry AMD.

 “We have been working hard to bring Valeda, a multiwavelength photobiomodulation device to our U.S. patients for several years. We now have a noninvasive treatment option for dry AMD patients that may improve vision and address the disease earlier, before permanent vision loss,” Clark Tedford, PhD, President and CEO, said in a company news release. “The FDA authorization of the Valeda treatment to improve vision in dry AMD now provides a significant option for our US patients.”

The Valeda therapy uses photobiomodulation (PBM), a noninvasive, light-based technology designed to improve visual acuity in patients suffering from dry AMD. In clinical trials, Valeda demonstrated an improvement in best-corrected visual acuity (BCVA) by over 5 letters, which was sustained over 24 months. In the pivotal US LIGHTSITE III trial, the Valeda treatment met its primary endpoint, showing both safety and efficacy in improving and maintaining visual acuity over a 2-year period. Based on these results, LumiThera submitted the clinical data as part of a technical package under a De Novo request to the FDA, setting special controls for PBM devices aimed at treating dry AMD.

“The De Novo authorization established Valeda as the first device for treating dry AMD patients with vision loss, setting a benchmark for future PBM devices in this class to meet equivalent performance standards,” said Lori Holder, Vice President of Regulatory Affairs at LumiThera.

Beyond visual acuity gains, the Valeda system also demonstrated encouraging effects on various anatomical markers of AMD, which were observed and analyzed over the course of the study.

“The primary endpoint for the study was visual acuity gain,” said Glenn Jaffe, MD, Duke Reading Center. "However, we also followed multiple anatomical endpoints from BL throughout the 24-month study to determine whether PBM helped to preserve retinal anatomy. The PBM treatment had a beneficial effect on multiple anatomic biomarkers. For example, we looked at whether PBM affected progression to geographic atrophy and found that incident geographic atrophy was reduced in the PBM-treated eyes compared to the sham treated eyes respectively, 6.8% versus 24%. Although incident GA was not a prespecified clinical endpoint, the results supported overall safety benefits of treating earlier in dry AMD disease."

LumiThera submitted the US LIGHTSITE III clinical data as part of a technical package to the FDA under a premarket approval (PMA) application in 2023. Upon completion of the initial review, the FDA determined the best path to market would be to submit a De Novo request requesting classification of the device as a Class II with special controls.