Avulux has received De Novo marketing authorisation from the FDA, establishing the first recognised device classification for a lens designed to manage light sensitivity associated with migraine. The company said the decision defines how Avulux may be used and creates a new FDA‑recognised category of precision optical filter.
The De Novo pathway is used for first‑of‑its‑kind medical devices with no comparable products previously authorised in the US. Avulux said the new classification gives patients, eye care providers and commercial partners clarity on what the lens is and who it can help.
Avulux is indicated to block light at 480 nm and 590 nm while allowing the remaining visible spectrum through, reducing the impact of light sensitivity in patients aged 12 and older diagnosed with episodic migraine. It is worn like ordinary eyeglasses and can be made with or without a prescription.
“For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed,” said Dr Charles Posternack, Co‑Founder and Chief Executive Officer of Avulux. “There is growing recognition that light sensitivity is a serious medical concern in its own right. 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.”
Light sensitivity affects nearly 90% of people living with migraine and can force individuals away from work, family and daily life. Until now, there has been no FDA‑authorised option designed specifically to manage this symptom.
“Migraines in children are often underdiagnosed and undertreated, despite their profound impact on development, education, and overall well‑being,” explained Juan Espinoza, MD, Director and Principal Investigator of the Consortium for Technology & Innovation in Pediatrics. “At CTIP, we are committed to supporting innovations like Avulux that offer non-invasive and effective solutions to improve the lives of pediatric patients.”
The authorisation follows FDA review of clinical evidence, including randomised controlled trials and real‑world experience. Avulux has been dispensed to more than 50,000 wearers and is used by over 1,400 eye care providers across the US and Canada.
