Lumithera’s Valeda becomes the first FDA-approved treatment for vision loss caused by dry AMD
Dry AMD sufferers in the United States experiencing deteriorating vision have a new treatment option in the fight against blindness.
On Monday, Lumithera, Inc. (Poulsboro, Washington, United States) announced that the United States Food and Drug Administration (FDA) has approved the use of its Valeda Light Delivery System photobiomodulation (PBM) device for vision loss caused by the disease.
The agency’s decision to grant marketing authorization was supported by data from the US-based LIGHTSITE III trial, where best corrected visual acuities (BCVA) over 24 months were shown to be as good as 5 letters or more, or the equivalent of one line on a Snellen chart or 0.1 logMAR.
“The RCT results demonstrated clinical benefits in early to intermediate dry AMD patients out to 24 months and an excellent safety profile,” said Dr. David Boyer (USA). “Patients will now be able to try a non-invasive treatment that can help improve their vision earlier in the disease process. This is an exciting option for patients and something doctors and patients have been waiting for.”
LIGHTSITE III also demonstrated potential anatomical benefits from PBM treatment with Valeda including a possible reduction in geographic atrophy risk.
“We also followed multiple anatomical endpoints throughout the 24-month study to determine whether PBM helped to preserve retinal anatomy,” said investigator Dr. Glenn Jaffe (USA).
“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, [at] 6.8% versus 24%. Although incident GA was not a prespecified clinical endpoint, the results supported the overall safety benefits of treating earlier in dry AMD disease.
The regulatory agency granted Valeda marketing approval via its De Novo classification program, a pathway for medical devices without a precedent on the market deemed to be of low or moderate risk.
“The De Novo authorization established Valeda as the first device for treatment of dry AMD patients with vision loss and creates a threshold for this novel class of PBM devices that must show similar clinical and nonclinical performance controls equivalent to the Valeda Light Delivery System,” said Lori Holder, LumiThera’s vice president for regulatory affairs.
While the exact mechanism of action of PBM on dry AMD disease activity is not precisely known, it has been shown to stimulate mitochondrial energy production processes. This is believed to support the restoration of cellular function in various parts of the eye by providing additional bioenergetic resources for damaged or corrupted processes.
PBM has been studied across other parts of the human body, including in inflammatory processes and neurological and musculoskeletal conditions. The technology is also currently being studied for application in other ophthalmic conditions such as diabetic macular edema (DME) and diabetic retinopathy (DR).