The U.S. Food and Drug Administration (FDA) has authorized marketing of LumiThera, Inc.'s Valeda Light Delivery System, a significant advancement for patients suffering from dry age-related macular degeneration (AMD). This marks the first therapeutic option available for adult patients with this condition.
According to the CDC, approximately 19.8 million Americans aged 40 and older were living with some form of AMD in 2019. The Valeda Light Delivery System offers a new avenue for improving vision in these patients.
How the Valeda System Works
The Valeda Light Delivery System employs three light-emitting diodes that generate light at different wavelengths. This light is used to treat the patient's eye. Clinical data suggests that treatment with the device for about two years can lead to an average improvement in vision equivalent to approximately one line on an eye chart.
"Today’s action brings to market the first therapeutic option for adult patients with dry AMD," said Malvina Eydelman, M.D., director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices at the FDA’s Center for Devices and Radiological Health. "This authorization reinforces FDA’s commitment to assuring access to innovative, safe and effective medical devices to treat high-prevalence, degenerative conditions."
Additional FDA Actions
In related news, the FDA, in collaboration with the Environmental Protection Agency (EPA), announced the registration of the first antimicrobial treatment for pathogen reduction in pre-harvest agricultural water. This product is designed to combat foodborne pathogens like E. coli and Salmonella in water used for growing crops. This is the first label amendment approved under a revised efficacy protocol designed by the FDA and EPA to ensure robust treatment options are available for agricultural use.
Counterfeit Botox Investigation
The FDA Office of Criminal Investigations also reported the arrest of a Massachusetts spa owner, Rebecca Fadanelli, for allegedly performing thousands of illegal injections of counterfeit Botox, Sculptra, and Juvederm on clients over three years. The FDA is asking anyone who believes they received services involving a counterfeit drug or device from Fadanelli and/or Skin Beaute Med Spa to complete a questionnaire on the FDA’s website.
