Earlier this month, LumiThera Inc. submitted a De Novo request to the FDA for its lead product: the Valeda Light Delivery System (LDS).
Refresh me on this company.
Formed in 2023 and headquartered in Poulsbo, Washington, LumiThera is a medical device company targeting the diagnosis, treatment, and monitoring of ocular disease and dry AMD.
Now about this delivery system …
The Valeda LDS is a multi-wavelength and non-invasive treatment that uses multiwavelength photobiomodulation (PBM) to treat dry age-related macular degeneration (AMD).
The system uses a light-emitting diode system with three wavelengths (590 nm, 660 nm, and 850 nm) to carry a non-coherent, eye-safe column of light to deliver treatment to the eye via either an open or closed eyelid.
To note, the system was the first to be CE-approved in the European Union
It is currently authorized for investigational use only in the United States.
How does it work?
The system takes less than five minutes for treatment and can be done on a non-dilated pupil.
Nine applications are needed over a 3-week period, with additional treatments on follow-up visits.
Any notable clinical data to know about?
The LIGHTSITE I (NCT02725762) and LIGHTSITE II (NCT03878420) trials demonstrated sustained improvements in visual benefits and concluded PBM (ie: the Valeda LDS) could be considered a therapeutic treatment option for early to late dry AMD.
Plus, last fall, LumiThera received a small business innovative research (SBIR) phase 2 grant from the The National Institutes of Health (NIH) and National Eye Institute (NEI) to support the The launch of LIGHTSITE IIIB, an extension study on the system for dry AMD.
See here for details.
Didn’t the company just announce the initiation of another trial?
Yes! LumiThera also launched the European Union Registry Study (EUROLIGHT), the largest PBM trial ever to be conducted in dry AMD patients.
The study is retrospectively-collecting safety and clinical efficacy outcomes—such as best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) imaging data—of 500 to 1,000 patients who received PBM treatment every 4 to 6 months for up to 3 years.
The goal: to support reimbursement in multiple countries and provide important clinical information on the real-world use of Valeda LDS.
Now back to this submission: what’s a De Novo request?
Per the FDA, a De Novo classification is a “risk-based classification process” to provide a marketing pathway to classify novel medical devices that “provide reasonable assurance of safety and effectiveness for the intended use.”
To note, there must also not be a predicate device—a device that’s already legally marketed for the same intended use.
How does this compare to 510(k) clearance?
This request is similar to a 510(k) clearance in that they’re both market pathways for medical devices with low to moderate risk (Class I or Class II).
The major difference: 510(k) relies heavily on determining a “substantial equivalence” to an existing medical device.
I see … and in this case?
LumiThera is seeking a De Novo request for the Valeda LDS to reclassify the system as a Class II device. Under this process, it could potentially “be assigned an official classification as a Class II device with special controls,” according to the company.
These “special controls” are intended to maintain the device’s safety and efficacy.
So what led to the submission?
LumiThera originally submitted a premarket approval (PMA) application in 2023; upon review, the FDA indicated a De Novo request would be the next step for the Valeda LDS.
Gotcha. So how long is a typical review period?
Per the FDA, 150 days (compared to 180 days for a PMA).
And then what?
Pending the agency’s approval of the De Novo request, LumiThera could potentially introduce the Valeda LDS to the U.S. market by mid-2024.
Stay tuned!