MIAMI— Avulux, the manufacturer of clinically-proven precision light-filtering lenses for people living with migraine and light sensitivity, has announced that the U.S. Food and Drug Administration (FDA) has granted the company De Novo marketing authorization—which is used for new, first-of-their-kind types of medical devices—establishing the first FDA-recognized category for a precision optical filter designed to help manage light sensitivity associated with migraine. The authorization gives Avulux a defined regulatory pathway as a first-of-its-kind medical device, one the company said provides patients and clinicians with a clearer way to understand its intended use.
The announcement said, Avulux is a precision optical filter indicated to block light at 480 nm (high blue range) and 590 nm (red/amber range), while allowing light in the remaining visible color spectrum through, decreasing the impact of light sensitivity in patients diagnosed with episodic migraine, aged 12 years and older. The company said Avulux is not intended to change the usual care therapy of patients diagnosed with episodic migraine, including medication usage, but complement it. The lens is worn like ordinary eyeglasses and can be made with or without a wearer’s vision prescription, the announcement said.
“For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed,” said Charles Posternack, MD, co-founder and chief executive officer 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.”
Migraine affects more than 1 billion people worldwide and more than 45 million in the U.S. alone, according to figures cited by the company. Avulux said as many as 90 percent of people with migraine experience light sensitivity, and that up to 60 percent of attacks are triggered by light or glare. Migraine also affects an estimated 11 percent of children and adolescents, with prevalence rising through the teen years, particularly among girls, the company said.
Specific wavelengths of light have been shown to trigger or worsen migraine attacks, the announcement said. By blocking those wavelengths before they reach the eyes while letting the remaining visible color spectrum through, Avulux decreases the impact of light sensitivity in patients with episodic migraine.
“Migraines in children are often underdiagnosed and undertreated, despite their profound impact on development, education, and overall well-being,” said Juan Espinoza, MD, director and principal investigator of the Consortium for Technology & Innovation in Pediatrics (CTIP), a prominent FDA-funded pediatric medical device accelerator dedicated to improving health outcomes for infants, children and adolescents. “At CTIP, we are committed to supporting innovations like Avulux that offer non-invasive and effective solutions to improve the lives of pediatric patients.”
The company said the authorization follows FDA review of clinical evidence supporting Avulux, including randomized controlled trials and years of real-world experience. Avulux said it has been dispensed to more than 50,000 wearers and is used by more than 1,400 eyecare providers in the U.S. and Canada.
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