The FDA has granted De Novo marketing authorization to Avulux for its precision light-filtering lenses designed to help patients with migraine and light sensitivity.
Let’s start with a refresh: What exactly is a De Novo authorization?
This is an official “legal green light,” so to speak, from the FDA that allows a specific manufacturer to market and sell a first-of-its-kind medical device.
- Essentially, it confirms the device is safe and effective for public use (based on test data and controls).
- See here for more on what this means from a regulatory standpoint.
And how does it compare to a De Novo classification?
De Novo classification is the act of categorizing the risk level and creating a new generic type of device—with a category and product code—whereas authorization is the specific approval for that specific device to be commercially sold.
- Important to note: There can’t be a predicate device—a device that’s already legally marketed for the same intended use.
And the major difference from 510(k) classification: Unlike the De Novo, this relies heavily on determining a “substantial equivalence” to an existing medical device.
Gotcha. Now tell me more about Avulux.
Launched in 2018, Avulux grew out of one neuro-ophthalmologist's years of research into a precision lens technology developed and patented at the University of Utah's Moran Eye Center.
- The gist: light-blocking glasses for photophobia management in patients with migraine and light sensitivity
Can I get some background on its development?
Considering this isn’t our first time reporting on the glasses, see below for some background:
- Start here on how certain visible light wavelengths activate intrinsically photosensitive retinal ganglion cells (ipRGCs).
- Click here for later research into an alternative wavelength to ease migraine attacks—the basis for Avulux's tech.
- And for even more: Check out this deeper dive on its science.
- And see more research here (real-world included) as well as how Avulux stacks up against other light-blocking glasses.
Also worth noting: Last year, Avulux was added to the FDA-funded Consortium for Technology & Innovation in Pediatrics (CTIP).
So what is its official indication?
As a precision optical filter, Avulux is indicated to decrease the impact of light sensitivity in patients aged 12+ diagnosed with episodic migraines.
- Specifically: The lenses filter light at 480 nm (high blue range) and 590 nm (red/amber range), while still allowing light in the remaining visible color spectrum through.
Any precautions to be taken?
Avulux emphasizes that its glasses are intended to complement—not replace—patients’ usual migraine care.
- As such, patients diagnosed with episodic migraines are advised to continue their prescribed treatment, including medication.
Also worth noting: Avulux is intended to be worn like ordinary eyeglasses and can be made with or without a wearer's vision prescription.
Noted. Talk more about this design.
The glasses’ lens technology is embedded in readers, prescription, and non-prescription glasses custom-made and tailored to a wearer and their respective lifestyles—with various frame shape options.
And the lenses themselves?
These are precision-tinted, hard-coated, anti-scratch, and available in a variety of styles (including models that fit over patients’ current frames).
- Check out Avulux’s shop of frame and lens options, and see here for the virtual try-on capabilities.
And just in the last few months: The company expanded this lens portfolio by adding two new lens options that can be embedded in the Avulux frames.
I’m listening …
Those include:
- Avulux Adapt photochromic lenses
- Read up on these.
- Avulux Atlas polarized lenses
- Click here for details.
And as I’m sure you’re curious: Check out how the photochromic and polarized lenses compare to the original Avulux lens (hint: the difference is in how each targets different lighting needs and preferences).
Now circling back to this latest news: What’s the big-picture significance?
Prior to its De Novo authorization: Avulux marketed under the FDA’s “general wellness” policy, which basically allowed them to be sold without any formal regulatory clearance as a medical device.
And now: This authorization status establishes Auvulux as the “first and only FDA De Novo-authorized precision optical filter.”
And lastly: their availability.
As the company noted, Avulux has already been dispensed to over 50,000 wearers across North America. They’re also available for purchase through select eyecare providers (ECPs) and optical retailers in Australia, New Zealand, and the United Kingdom.
And in the United States: They are FSA- and HSA-eligible.
- For patients: Click here to connect with an Avulux provider.
- For ECPs: Click here to learn how to become an Avulux provider.