What You Should Know
- The U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization to Avulux, establishing a first-of-its-kind, FDA-recognized medical device classification for precision optical filters designed to manage migraine-associated light sensitivity.
- Decreases the impact of light sensitivity in patients diagnosed with episodic migraine aged 12 years and older, serving as an over-the-counter, non-invasive complement to usual care and pharmacological therapies.
- Selectively blocks harmful wavelengths at 480 nm (high blue range) and 590 nm (red/amber range) while allowing soothing green light and the remaining visible spectrum to pass through without distorting color perception.
- Light sensitivity (photophobia) affects nearly 90% of the 1+ billion people living with migraine globally (over 45 million in the U.S.), with light or glare triggering up to 60% of attacks—yet standard pharmaceutical medications do not directly treat optical sensitivity.
- Supported by the Consortium for Technology & Innovation in Pediatrics (CTIP), an FDA-funded pediatric medical device accelerator, expanding non-pharmacologic interventions for adolescents where migraine prevalence surges.
- Available with or without a vision prescription through an established network of over 1,400 eye care providers across the U.S. and Canada, with more than 50,000 lenses already dispensed.
Filtering the Pain Pathway Without Distorting Color
Cleared for patients aged 12 and older, Avulux’s optical filter is designed to be worn as everyday eyewear—either as non-prescription lenses or customized with a patient’s corrective prescription.
Instead of acting as a dark blanket across all light, the lens uses a notch-filtering design that targets the specific wavelengths known to provoke migraine symptoms:
- Blocks Trigger Wavelengths: Specifically attenuates narrow bands of the spectrum at 480 nm (blue light) and 590 nm (amber/red light). These wavelengths activate intrinsically photosensitive retinal ganglion cells (ipRGCs), which transmit pain signals through the trigeminal nerve pathway during an attack.
- Transmits Soothing Green Light: By allowing calming green wavelengths and the rest of the visible spectrum to pass through, the lens preserves normal color balance and lets patients work under harsh office, classroom, or digital screen lighting without plunging them into darkness.
- Clinical Trial Backing: The FDA decision follows multi-center, double-blind, placebo-controlled trials showing that the lens produced statistically significant drops in photophobia impact compared to sham controls.
The pediatric clearance was accelerated through the Consortium for Technology & Innovation in Pediatrics (CTIP), an FDA-funded program focused on getting non-invasive medical technology into the hands of younger patients who struggle with classroom lighting.
Avulux is currently available over the counter through more than 1,400 optometry, ophthalmology, and optical practices across North America.
“For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed,” said Dr. Charles Posternack, co-founder and CEO of Avulux. “There is growing recognition that light sensitivity is a serious medical concern in its own right. This authorization gives patients and providers a clear, FDA-recognized option designed specifically to manage the impact of light in those with migraine, one we hope will soon become the standard of medical care in this population.”
