LumiThera submits de novo request for Valeda light delivery system for dry AMD
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Key takeaways:
- LumiThera submitted a de novo request to the FDA for the Valeda light delivery system.
- The photobiomodulation device is under review for the treatment of dry age-related macular degeneration.
LumiThera submitted a de novo request to the FDA to reclassify the Valeda light delivery system as a Class II device for the treatment of dry age-related macular degeneration, according to a press release.
“We are excited and hopeful that we can bring the technology into the U.S. for patients with early to intermediate dry AMD, where few treatment options exist,” Clark E. Tedford, PhD, president and CEO of LumiThera, told Healio. “We believe the FDA has established a clear pathway for market approval for the novel Valeda light delivery system with the de novo process with special controls.”
After the FDA reviewed and provided feedback on the premarket approval (PMA) application for the system, which included positive data from the LIGHTSITE III trial, the company decided to pursue the de novo request.
The request reflects the benefit-to-risk profile and provides a path for novel devices to reach the market and special controls to maintain safety and efficacy of the device, the release said.
The FDA review time for the de novo application is 150 days compared with 180 days for a PMA, not including additional time for interactive review.
“The de novo classification is a special pathway for novel devices vs. the PMA route and establishes a threshold for this novel class of [photobiomodulation] devices that must show similar clinical and nonclinical performance controls similar to the Valeda light delivery system,” Lori Holder, vice president, regulatory affairs, LumiThera, said in the release. “Our discussions with the FDA [have] indicated this is the correct path forward for LumiThera’s treatment for dry AMD patients.”
Editor’s note: This article was updated on Jan. 3, 2024, to include comments from Clark E. Tedford, PhD.
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