FDA Clears Avulux Migraine Lenses

FDA De Novo authorization establishes a new device classification for lenses designed to reduce migraine-associated light sensitivity

To provide a new option for managing light sensitivity associated with migraine through precision light-filtering lenses.

Device Classification: The FDA granted De Novo marketing authorization to Avulux for its lenses, establishing a new device classification for managing light sensitivity in migraine patients.
Lens Design: The lenses block light at 480 nm in the high-blue range and 590 nm in the red/amber range, allowing the rest of the visible spectrum to pass through.
Patient Guidance: Patients aged 12 years and older are advised to continue their usual migraine treatments alongside using the lenses.

Light sensitivity is a common symptom in migraine, affecting up to 90% of patients.
Light or glare may trigger up to 60% of migraine attacks.
The lenses have been dispensed to over 50,000 users and are available through a network of over 1,400 eye care providers.

The lenses are indicated only for patients with episodic migraine.
The effectiveness of the lenses in replacing standard migraine treatments has not been established.