FDA grants De Novo authorisation to light-filtering device for migraine
pharmafile | August 28, 2026 | News story | | De Novo, FDA, light-filtering device, migraine
The US Food and Drug Administration (FDA) has granted De Novo marketing authorisation to Avulux, a precision optical filter designed to reduce the impact of light sensitivity in people aged 12 and older with episodic migraine.
The decision establishes a new FDA-recognised classification for the device, which filters specific wavelengths of light associated with migraine symptoms. Avulux blocks light at wavelengths of 480nm and 590nm while allowing the remainder of the visible spectrum to pass through.
Light sensitivity, or photophobia, is a common feature of migraine and can contribute significantly to the disruption caused by attacks. Avulux is intended to be worn like conventional glasses, with or without a prescription, and is designed to complement rather than replace existing migraine treatment.
The FDA’s De Novo pathway is used to establish classifications for novel medical devices for which there is no comparable device already authorised in the US.
The authorisation was supported by clinical evidence including randomised controlled trials and real-world experience, according to Avulux. The company said its lenses have previously been supplied to more than 50,000 users through a network of more than 1,400 eye-care providers in the US and Canada.
Dr Charles Posternack, Co-founder and CEO of Avulux, said: “This authorisation gives patients and providers a clear, FDA-recognised option designed specifically to manage the impact of light in those with migraine.”
The device is now available through participating eye-care providers, optical practices and authorised partners in the US.
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