Avulux announced the US Food and Drug Administration (FDA) has granted the company De Novo marketing authorization. The authorization establishes a defined FDA-recognized classification for Avulux, which is designed to help manage light sensitivity associated with migraine, the company said in a press release.
The FDA De Novo pathway is used for new types of medical devices that are first of their kind, with no comparable medical device previously authorized by the FDA in the United States. According to the company, the decision defines how Avulux may be used and creates a new FDA-recognized classification of precision optical filter, giving patients, eyecare providers, health care providers, and commercial partners a clear way to understand what Avulux is and who it can help.
Avulux is a precision optical filter indicated to block light at 480 nm (high blue range) and 590 nm (red/amber range), while allowing light in the remaining visible color spectrum through, to decrease the impact of light sensitivity in patients diagnosed with episodic migraine aged 12 years of age and older. According to the company, the use of Avulux should not alter the usual care therapy of patients diagnosed with episodic migraine, including medication usage. It is worn like ordinary eyeglasses and can be made with or without a wearer's vision prescription. OM