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FDA De NovoFDA De Novo. Stage 4 of 4 (Authorized)

FDA Grants De Novo to Avulux Lenses for Migraine-Associated Light Sensitivity

The authorization creates a new device type for light-filtering lenses, indicated for people 12 and older with episodic migraine and sold over the counter.

By News DeskAugust 25, 20262 min read
A smiling woman wearing clear-framed glasses with amber-tinted lenses, with a circular inset of a hand holding a lens as colored light rays pass through it
A promotional image from Avulux showing a model wearing amber-tinted Avulux lenses, with an inset illustrating light passing through a lens. Photo: Avulux · Company press image distributed with Avulux's August 24, 2026 PR Newswire release
FDA De Novonew device type · DEN250026FDA De Novo. Stage 4 of 4 (Authorized)

The FDA granted this device through the De Novo pathway, used for new low-to-moderate-risk device types with no existing equivalent.

Key points

  • The FDA granted De Novo request DEN250026 for Avulux on August 21, 2026, creating the classification 'light attenuation lenses for migraine-associated light sensitivity'.
  • The lenses block light at 480 nm and 590 nm and are indicated for people aged 12 and older with episodic migraine, according to the company.
  • Avulux says its lenses were already worn by more than 50,000 people through over 1,400 eye care providers before the authorization.

The US Food and Drug Administration has granted De Novo marketing authorization to Avulux, eyeglass lenses that filter specific wavelengths of light to decrease the impact of light sensitivity in people with episodic migraine, the Miami company announced on August 24. The decision creates a new FDA device type for this kind of optical filter.

The FDA's De Novo database lists request DEN250026 for Avulux, filed by Matap II, LLC, of Aventura, Florida. The agency received the request on June 23, 2025, and granted it on August 21, 2026. The new classification, "light attenuation lenses for migraine-associated light sensitivity," sits under regulation 882.5811 with product code QEO and was reviewed by the neurology panel. The De Novo pathway is used for new types of low- to moderate-risk devices that have no existing equivalent on the market.

The indication

According to the company, Avulux is indicated to block light at 480 nanometers, in the high blue range, and 590 nanometers, in the red and amber range, while letting the rest of the visible spectrum through, to decrease the impact of light sensitivity in patients aged 12 and older diagnosed with episodic migraine. The release states that use of Avulux should not alter the usual care of those patients, including medication use. The lenses are worn like ordinary glasses, with or without a vision prescription, and are authorized for over-the-counter use.

The company said the FDA reviewed clinical evidence including randomized controlled trials and years of real-world experience. One of the trials it cites, published in the Journal of Clinical Neuroscience in 2023, was a randomized double-blind study. HIT Consultant reported that the decision followed multicenter, double-blind, placebo-controlled trials in which the lenses produced statistically significant reductions in the impact of light sensitivity compared with sham controls. The release did not give effect sizes.

The pediatric indication was supported by the Consortium for Technology and Innovation in Pediatrics, an FDA-funded pediatric device accelerator, according to the company and HIT Consultant.

Already on sale

Avulux lenses were on the market before the authorization. The company said they have been dispensed to more than 50,000 wearers through a network of more than 1,400 eye care providers in the US and Canada, and are available through participating eye care providers, optical practices and authorized partners.

"There is growing recognition that light sensitivity is a serious medical concern in its own right," said Charles Posternack, Avulux's co-founder and chief executive. "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."

Avulux described itself in the release as the maker of the only De Novo-authorized precision optical filter for this indication. The company did not disclose pricing in the announcement.

Sources

  1. Avulux Granted FDA De Novo Authorization, Creating the First Lens Classification for Migraine-Associated Light Sensitivity, Avulux (PR Newswire), August 24, 2026
  2. De Novo DEN250026: Avulux, US Food and Drug Administration, August 21, 2026
  3. FDA Grants De Novo Authorization to Avulux, Establishing First Device Classification for Migraine Light Sensitivity, HIT Consultant, August 25, 2026