FDA Clears Avulux Migraine Lenses
FDA De Novo authorization establishes a new device classification for lenses designed to reduce migraine-associated light sensitivity
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The FDA has granted De Novo marketing authorization to Avulux for its precision light-filtering lenses for migraine management.
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Avulux lenses are indicated for patients aged 12 and older with episodic migraine and are designed to block specific light wavelengths.
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The lenses aim to reduce light sensitivity impact without replacing standard migraine treatments, which patients should continue.
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Avulux lenses have been dispensed to over 50,000 users and are available through a network of more than 1,400 eye care providers.
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The authorization creates a new FDA classification for precision optical filters addressing migraine-associated light sensitivity.
