FDA authorizes Avulux light-filtering lenses for migraine-associated light sensitivity in patients 12 and older

The US Food and Drug Administration (FDA) has granted De Novo marketing authorization to Avulux precision light-filtering lenses to decrease the impact of light sensitivity in patients aged 12 years and older with episodic migraine, according to a company announcement.¹

The authorization establishes a new FDA-recognized device classification for a precision optical filter intended to address migraine-associated light sensitivity. Avulux lenses are available over the counter and can be worn with or without a patient's vision prescription.¹

The lenses are designed to block light at wavelengths of 480 nm, in the high-blue range, and 590 nm, in the red/amber range, while allowing light in the remaining visible spectrum to pass through. The device is intended to reduce the effects of light sensitivity and is not intended to replace medications or other usual migraine treatment.¹

"For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed," Charles Posternack, cofounder and chief executive officer of Avulux, said in the press release. "There is growing recognition that light sensitivity is a serious medical concern in its own right."

Light sensitivity is common among patients with migraine

Migraine affects approximately 15% of the global population, with more than 1 billion people affected worldwide.²,³ Light sensitivity is reported by as many as 90% of patients with migraine, and light or glare may trigger up to 60% of migraine attacks.⁴,⁵

Migraine also represents a clinical concern in pediatric and adolescent populations. A 2023 systematic review and meta-analysis estimated that migraine affects approximately 11% of children and adolescents.⁶ Prevalence increases through adolescence, with a greater burden among girls.⁷

Research has demonstrated that specific wavelengths of light may contribute to the exacerbation of headache in patients with migraine.⁸ Avulux is designed to filter selected wavelengths before they reach the eyes while maintaining transmission of other visible wavelengths.

For pediatricians, the FDA indication means the lenses may be considered for adolescents aged 12 years and older who have been diagnosed with episodic migraine and experience light sensitivity. Patients should continue their existing migraine treatment, including prescribed medications.

"Migraines in children are often underdiagnosed and undertreated, despite their profound impact on development, education, and overall well-being," Juan Espinoza, MD, director and principal investigator of the Consortium for Technology & Innovation in Pediatrics, said in the release. "At CTIP, we are committed to supporting innovations like Avulux that offer non-invasive and effective solutions to improve the lives of pediatric patients."

Clinical evidence supports FDA authorization

According to Avulux, the FDA authorization followed review of clinical evidence that included randomized controlled trials and real-world use.¹

A randomized, double-blind trial published in the Journal of Clinical Neuroscience in 2023 evaluated the use of Avulux lenses to reduce headache pain and light sensitivity in patients with migraine.⁹ Additional research published in 2025 evaluated the effect of the lenses on visual photosensitivity discomfort thresholds in healthy volunteers.¹⁰

The company reported that the lenses have been dispensed to more than 50,000 individuals and are used by a network of more than 1400 eye care providers in the United States and Canada.¹

The FDA's De Novo pathway is intended for novel medical devices for which there is no legally marketed predicate device. The authorization establishes a new device classification and regulatory pathway for subsequent devices of the same type.

Avulux lenses are available through participating eye care providers, optical practices, and authorized partners. The company stated that patients aged 12 years and older with episodic migraine may be referred for the lenses without altering their existing migraine management plan.

References

1. Avulux. Avulux granted FDA De Novo authorization, creating the first lens classification for migraine-associated light sensitivity. Press release. August 26, 2026. https://www.prnewswire.com/news-releases/avulux-granted-fda-de-novo-authorization-creating-the-first-lens-classification-for-migraine-associated-light-sensitivity-302857820.html?tc=eml_cleartime

2. Steiner TJ, Stovner LJ, Birbeck GL. Migraine: the seventh disabler. J Headache Pain. 2013;14:1.

3. 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. doi:10.3389/fneur.2021.800605

4. Wu Y, Hallett M. Photophobia in neurologic disorders. Transl Neurodegener. 2017;6:26. doi:10.1186/s40035-017-0095-3

5. Brennan KC, Digre KB. Shedding light on photophobia. J Neuroophthalmol. 2012;32(1):68-81. doi:10.1097/WNO.0b013e3182474548

6. 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. doi:10.1186/s10194-023-01541-0

7. Li Y, Hu N, Fan B, et al. Rising global burden of migraine among adolescents and young adults: a 30-year analysis (1990-2021). Front Neurol. 2025;16:1652468. doi:10.3389/fneur.2025.1652468

8. 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

9. 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

10. Talbert C, Goturi N, Pondelis NJ, et al. Avulux lens increases visual photosensitivity discomfort thresholds in healthy volunteers. Invest Ophthalmol Vis Sci. 2025;66(8):3732.