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A pivotal clinical trial that cleared the way for U.S. regulators to approve a new light therapy device as a treatment for macular degeneration has been criticized for several shortcomings, with a warning issued that a host of questions must be answered before clinicians prescribe the device.

In a “viewpoint” published in JAMA Ophthalmology in late January, Srinivas Sadda, MD, a retina specialist at Doheny Eye Institute in Pasadena, California, and a professor at UCLA David Geffen School of Medicine, called for more data before clinicians can “confidently” recommend the device to their patients. The publisher released the viewpoint as Online First “because of public health importance.”

The U.S. Food and Drug Administration (FDA) granted De Novo approval to the device, known as the Valeda Light Delivery System (LumiThera), in November 2024, based on the results of the LIGHTSITE III trial. De Novo is a regulatory pathway for novel medical devices that carry what the agency determines is a low to moderate risk for harm but have no equivalent comparator device. Head over to Medscape to read the full story.