MIAMI — Avulux announced that the U.S. Food and Drug Administration has granted De Novo marketing authorization for its precision light-filtering lens designed to reduce the impact of light sensitivity in patients with episodic migraine.
The authorization establishes a new FDA-recognized device classification for precision optical filters used to manage migraine-associated light sensitivity.
Avulux is indicated for patients ages 12 and older with episodic migraine. The lenses are designed to block light at 480 nanometers in the high-blue range and 590 nanometers in the red-amber range while allowing the remaining visible light spectrum to pass through.
The product is worn like ordinary eyeglasses and can be made with or without a vision prescription. Avulux is intended to complement, rather than replace, standard migraine treatment, including medications.
“For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed,” said Charles Posternack, 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.”
Light sensitivity is common among people with migraine and can significantly interfere with work, school and daily activities. The company said as many as 90% of people with migraine experience light sensitivity, while up to 60% of migraine attacks may be triggered by light or glare.
The FDA authorization follows a review of clinical evidence that included randomized controlled trials and real-world use.
Avulux said its lenses have been dispensed to more than 50,000 users and are available through a network of more than 1,400 eye care providers in the United States and Canada.
“Migraines in children are often underdiagnosed and undertreated, despite their profound impact on development, education, and overall well-being,” said Juan Espinoza, M.D., Director and Principal Investigator of the Consortium for Technology & Innovation in Pediatrics. “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 FDA authorization gives healthcare and eye care providers a regulated option specifically intended to address migraine-related light sensitivity in adults and adolescents.
