The US Food and Drug Administration has granted De Novo marketing authorization to Avulux for its precision light-filtering lenses, establishing a new FDA-recognized device classification for managing light sensitivity associated with migraine.
The lenses are indicated for patients aged 12 years and older with episodic migraine. They are designed to block light at 480 nm in the high-blue range and 590 nm in the red/amber range, while allowing the remainder of the visible spectrum to pass through.
According to Avulux, the aim is to reduce the impact of light sensitivity without replacing standard migraine treatment. Patients are advised to continue their usual care, including prescribed medications.
The De Novo pathway is used for novel medical devices for which there is no legally marketed predicate device. The authorization therefore creates a new FDA classification for precision optical filters intended to address migraine-associated light sensitivity.
“For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed,” said Charles Posternack, co-founder and CEO of Avulux. “This authorization gives patients and providers a clear, FDA-recognized option designed specifically to manage the impact of light in those with migraine, one we hope will soon become the standard of medical care in this population.”
Photophobia is among the most common symptoms experienced by people with migraine, with the company citing published estimates suggesting that as many as 90% of patients experience light sensitivity and that light or glare may trigger up to 60% of attacks.
The authorization follows FDA review of clinical evidence that included randomized controlled studies and data from real-world use. Avulux said its lenses have been dispensed to more than 50,000 users and are currently offered through a network of more than 1,400 eye care providers across the US and Canada.
The lenses are worn in the same way as standard eyeglasses and can be manufactured with or without prescription correction.
Avulux is authorized for over-the-counter use and is available through participating eye care providers, optical practices, and authorized partners. The company said the authorization could broaden access for both adult and adolescent patients with episodic migraine who experience clinically significant light sensitivity.
Source: Avulux.
