Avulux has obtained de novo marketing authorisation from the US Food and Drug Administration (FDA) for its optical lenses for managing light sensitivity associated with migraine, making it the first product of its kind to achieve the designation.
The Florida-based company’s precision optical filter is indicated to decrease the impact of light sensitivity in patients aged 12 years and older diagnosed with episodic migraine.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Research indicates that over 45 million people in the US are affected by episodic migraine, while up to 90% of people living with the neurological condition cite light sensitivity as a symptom, with up to 60% of migraine attacks triggered by harsh light or glare. Episodic migraine occurs on fewer than 15 days per month.
Worn like regular eyeglasses, Avulux’s lens technology uses a dual-band optical filter that is designed to block up to 97% of blue, amber, and red light — light wavelengths that stimulate intrinsically photosensitive retinal ganglion cells (IPRGCs) and have been demonstrated to exacerbate headache-associated light sensitivity — while letting soothing green light pass through, the company stated.
Clearance for the eyeglasses, which are intended to complement rather than replace usual migraine care such as the gold standard of triptans, was supported by Avulux’s clinical evidence from several studies. In a clinical evaluation (NCT04341298), Avulux’s IPRGC lenses were associated with clinically and statistically significant reductions in two- and four-hour headache pain in a post-hoc analyses of 78 patients with baseline headache pain scores ≥ 2 on an 11-point scale.
Avulux’s CEO, Dr Charles Posternack, commented: “For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed. There is growing recognition that light sensitivity is a serious medical concern in its own right.
“This authorisation gives patients and providers a clear, FDA-recognised 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.”
In the medtech industry, companies are at various developmental stages for migraine treatments that are designed to provide relief via neuromodulation. These include ShiraTronics, which is developing an implantable neuromodulation system for chronic migraine (CM) relief. In a readout from September 2025, the company’s system demonstrated an 11.3-day mean reduction in monthly headache days (MHD) for CM patients in a pilot study evaluating its device.
Meanwhile, Theranica’s neuromodulation-based therapy for relieving migraine symptoms secured FDA clearance in March 2023, and Nocira gained approval breakthrough device designation from the agency in April 2022 for its automated variable pulse insufflation (AVPI) device that administers gentle, controlled puffs of air in the ears to treat migraine attacks. However, prescription drugs such as triptans remain the go-to treatment for the condition.
