Photo provided by Avulux
By Charles Posternack, MD, FACP, FRCPC
August 26, 2026
My journey to founding Avulux began in the most personal way imaginable. My oldest daughter was having migraine attacks severe enough that she would lock herself in her room with the lights off. Nothing on the market seemed to help her.
As a father and as a physician I felt totally helpless, so my focus became finding any solution that could make her life better. I did not plan on becoming a medical innovator. I was a senior healthcare executive and practicing physician, but neither a neurologist nor ophthalmologist. I also quickly realized that I was not alone in feeling the way that I did.
That is why earning De Novo Authorization from the U.S. Food and Drug Administration is such an important milestone, both personally and professionally. Avulux is now the first spectacle lens with marketing authorization for a non-ophthalmic related medical condition, in our case, migraine. It is also an important recognition that light sensitivity is not simply an ocular issue, but a medical condition.
WHAT THIS CERTIFICATION MEANS
We are now entering a new chapter in the U.S. after more than a decade of research, development and trials. The FDA has recognized Avulux as a medical device with its own regulatory category.
De Novo marketing authorization is the least common of FDA classifications. It is reserved for products that do not fit an existing category because there is no substantially similar device already on the market. That is different from FDA clearance, which is used for products that are substantially equivalent to something already on the market, and from FDA approval, which is generally reserved for higher-risk medical devices and pharmaceuticals.
That matters because the FDA standard is the gold standard in medicine. It gives practitioners confidence that a product has been reviewed for its intended use and that the evidence supports its benefit-risk profile.
THE OPTOMETRIC PROFESSION’S WARM WELCOME
One of the most rewarding parts of this journey has been how the optometric profession welcomed us. I knew very few people in the optical industry, so I felt fortunate that so many were willing to listen and help.
Migraine is so common that it touches nearly everyone. When you talk about it, people immediately think of a friend, family member, or colleague who struggles with it. I met professionals at Vision Expo, through Vision Council and across the optical industry who were genuinely interested.
That support mattered. It helped us move from an idea shaped by family need into an actual lens product that could help so many disabled by migraine.
OPPORTUNITY FOR OPTOMETRISTS
Migraine is one of the most prevalent diseases in the world, affecting more than a billion people, and it is a leading cause of disability in people under age 50. Yet there are only about 800 headache specialists in the United States.
Many migraine sufferers use vision correction, so the vast majority are already seeing an eyecare professional. Optometrists will see far more of these patients than specialists do.
Over the past few years, the optometric profession in the U.S. has been ahead of the curve in adopting Avulux and helping their patients. Our goal is to support the industry and help patients get properly refracted, select frames they like and work with doctors who understand their needs. We want our technology to keep patients connected to your office, with a product that isn’t designed for online shopping.
In that context, optometrists have a real opportunity to help. Many patients are already walking into practices saying they have heard about Avulux, and we expect that to continue more frequently. That changes the conversation from us trying to explain the problem to providers recognizing that patients are actively seeking a solution.
WHERE VISION MET EXPERTISE
I may be the person most closely associated with the company’s origin, but its growth has always been a team effort. I had the idea, but I needed a strong team to make it real. I needed people who understood lenses, manufacturing and research and development.
That search led me to a chance introduction to neuro-ophthalmologist and medical researcher Bradley Katz, MD, PhD, and to Steve Blair, PhD, an electrical engineer and professor at the University of Utah, who had done research into light. The concept was compelling: if we could manipulate certain wavelengths of light, perhaps we could improve migraine-related light sensitivity. I negotiated an agreement with the University of Utah Research Foundation to secure rights to the intellectual property and committed to turning this idea into something marketable.
With the science in hand, the team got to work creating the physical optical lens. The first prototype used a thin film focused on blocking light around 480 nanometers in the blue range, thought to be a major driver of light sensitivity. It did show promise, but the lens was too dark, it required wrap frames, was too costly to mass produce and was impractical for daily indoor use.
Over time, ongoing research into the biologic scientific basis for light sensitivity revealed that wavelengths of light in the red amber range also could precipitate sensitivity to light, while green light wavelengths could be soothing.
TODAY’S TECHNOLOGY AND TEAM
The research and development process took more than a decade to create the precision optical filter that Avulux is today. This was a journey fraught with failures and uncertainty, but was so worth the effort. Our portfolio has grown to also include Avulux Adapt, a photochromic option, and Avulux Atlas polarized sunglasses.
We are still a small company with fewer than 30 full-time equivalent team members, yet our reach has been strong. My younger daughter, also a migraine sufferer, is a core part of our team and wears Avulux herself.
We have sold Avulux all across the globe and more than 50,000 migraine sufferers have benefited from this technology. Yet I see this as just the beginning of our impact as a migraine management tool.
THE NEXT CHAPTER FOR AVULUX
We’re still focused on the same mission: improving activities of daily living for people who are dealing with a migraine attack or light sensitivity. With this FDA authorization, we see the opportunity to expand our impact.
Seeing how Avulux helps people in real life continues to drive our team.
A veteran who had come back from war had been unable to leave his home. After trying Avulux, he felt able to go out and look for work again. We helped him secure a job. That is beyond gratifying.
The story of Avulux extends beyond my daughter’s experience. I invite you to join us—or continue working with us—as we enter this next chapter. Optometrists can play a vital role in helping us on our mission of helping people feel better. And that’s a pretty remarkable legacy to be a part of.
This article is sponsored by Avulux
Read another Avulux success story from optical owner Tiffany Rosell, LDO, ABOC, NCLEC here.
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Charles Posternack, MD, FACP, FRCPC, is a co-founder and CEO of Avulux. Dr. Posternack has been in the healthcare sector for more than 30 years, with leadership positions in both the not-for-profit and for-profit sectors. |
