Avulux Granted FDA De Novo Authorization, Creating the First Lens Classification for Migraine-Associated Light Sensitivity

An FDA-authorized lens for the light sensitivity that affects nearly 9 in 10 people with migraine.

MIAMI, Aug. 24, 2026 /PRNewswire/ -- Avulux, the maker of clinically-proven precision light-filtering lenses for people living with migraine and light sensitivity, today announced that the U.S. Food and Drug Administration (FDA) has granted the company De Novo marketing authorization. The authorization establishes a defined FDA-recognized classification for Avulux, designed to help manage light sensitivity associated with migraine.

The FDA De Novo pathway is used for new types of medical devices that are first of their kind, with no comparable medical device previously authorized by the FDA in the U.S. The decision defines how Avulux may be used and creates a new FDA-recognized classification of precision optical filter, giving patients, eye care providers, healthcare providers, and commercial partners a clear way to understand what Avulux is and who it can help.

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, to decrease the impact of light sensitivity in patients diagnosed with episodic migraine aged 12 years of age and older. The use of Avulux should not alter the usual care therapy of patients diagnosed with episodic migraine, including medication usage. It is worn like ordinary eyeglasses and can be made with or without a wearer's vision prescription.

"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 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."

Why light matters in migraine

For millions of people living with migraine, light is a trigger and a source of pain that can send them into a dark room and away from work, family, and daily life. Light sensitivity is one of the most common and disruptive parts of the disease, yet until now there has been no FDA-authorized option designed to manage it.

Migraine is a neurological disease that affects nearly 15% of the world's population,¹ more than 1 billion people worldwide,² and, in the United States alone, over 45 million people. As many as 90% of people living with migraine³ experience light sensitivity as a symptom, and up to 60% of migraine attacks are triggered by light or glare.⁴ Migraine also affects an estimated 11% of children and adolescents,⁵ with prevalence rising through the teen years,⁶ particularly among girls.

Specific wavelengths of light have been shown to trigger or worsen migraine attacks.⁷ 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 12 and older. Avulux is intended to complement, not replace, usual migraine care. Patients should continue their prescribed treatment, including medication.

"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 authorization follows FDA review of clinical evidence supporting Avulux, including randomized controlled trials^8,9 and years of real-world experience. Avulux has been dispensed to more than 50,000 wearers and trusted by a network of over 1,400 eye care providers across the United States and Canada.

What this means for patients, providers, and partners

Healthcare providers and eye care providers both play an important role in connecting patients to Avulux. For the primary care physicians, pediatricians, and neurologists who manage migraine most often, Avulux addresses light sensitivity, a symptom that migraine medications are not designed to treat. Referring a patient 12 or older with episodic migraine who experiences light sensitivity takes only moments and does not change the patient's existing treatment.

For optometrists and optical practices, Avulux is the first and only FDA-authorized option to fit and dispense, giving migraine patients a reason to ask for it by name. And for the millions of people, now including adolescents 12 and older, who structure their days around avoiding light, there is now an authorized option designed specifically for them.

Patients can now access Avulux through participating eye care providers, optical practices, and authorized partners. Learn more at ecp.avulux.com/hcp.

About Avulux
Avulux is the maker of the first and only FDA De Novo authorized precision optical filter, indicated to decrease the impact of light sensitivity in patients diagnosed with episodic migraine aged 12 years and older. The leader in light management lenses for people living with migraine and light sensitivity, Avulux offers a portfolio of clinically proven lenses that manage light across indoor, outdoor, and changing light environments. Avulux lenses are worn like ordinary eyeglasses and can be made with or without a wearer's vision prescription. Authorized for over-the-counter use, Avulux is available without a prescription through eye care providers, optical practices, and authorized partners. Learn more at avulux.com.

Media Contacts

Ari Avila, Marketing Manager
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Supreme Communications for Avulux
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References

¹ Steiner et al.: Migraine: the seventh disabler. The Journal of Headache and Pain 2013 14:1.
² Amiri P, Kazeminasab S, Nejadghaderi SA, et al. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022;12:800605. Published 2022 Feb 23. doi:10.3389/fneur.2021.800605
³ Wu Y, Hallett M. Photophobia in neurologic disorders. Translational Neurodegeneration. 2017;6:26. doi:10.1186/s40035-017-0095-3
⁴ Brennan KC, Digre K. Shedding Light on Photophobia Journal of Neuro-Ophthalmology. 2012;32(1):68-81. doi:10.1097/WNO.0b013e3182474548
⁵ Onofri A, Pensato U, Rosignoli C, et al. Primary headache epidemiology in children and adolescents: a systematic review and meta-analysis. J Headache Pain. 2023;24(1):8. Published 2023 Feb 14. doi:10.1186/s10194-023-01541-0
⁶ Li Y, Hu N, Fan B, Wang X, Mao P, Zhang Y and Li Y (2025) Rising global burden of migraine among adolescents and young adults: a 30-year analysis (1990–2021). Front. Neurol. 16:1652468. doi: 10.3389/fneur.2025.1652468
⁷ Noseda R, Kainz V, Jakubowski M, et al. A neural mechanism for exacerbation of headache by light. Nat Neurosci. 2010;13(2):239-245. doi:10.1038/nn.2475
⁸ Posternack C, Kupchak P, Capriolo AI, Katz BJ. Targeting the intrinsically photosensitive retinal ganglion cell to reduce headache pain and light sensitivity in migraine: A randomized double-blind trial. J Clin Neurosci. 2023;113:22-31. doi:10.1016/j.jocn.2023.04.015
⁹ Talbert C, Goturi N, Pondelis NJ, Aguilar MC, Gonzalez A, Durkee HA, Parel JMA, Faria V, Moulton E. Avulux lens increases visual photosensitivity discomfort thresholds in healthy volunteers. Invest Ophthalmol Vis Sci. 2025;66(8):3732.

SOURCE Avulux