Objective:

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

Approach:

• 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.

Key Findings:

• 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.

Limitations:

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

Sources:

• Avulux