The FDA-funded Consortium for Technology & Innovation in Pediatrics (CTIP) has selected the latest innovator to join its product portfolio: a next-generation optical technology called Avulux.
First, a rundown on CTIP.
Established in 2011, CTIP is a pediatric medical device (MedTech) accelerator operating out of the Ann & Robert H. Lurie Children’s Hospital of Chicago and Children's Hospital Los Angeles (CHLA).
Its purpose: To advance the development and commercialization of pediatric medical devices by connecting and working directly (and simultaneously) with a wide range of stakeholders—clinicians, engineers, regulators, hospital administrators, industry professionals, patients, and the business community.
- What makes this possible: CTIP has received three rounds of 5-year funding from the FDA through its Pediatric Device Consortia (PDC) grant program over the last 12 years (2013, 2018, and 2023).
And its product portfolio?
Encompassing over 100 MedTech innovations, each company in CTIP’s portfolio is given access to a network of clinical, scientific, regulatory, and business experts to “help refine their device and business plans.”
CTIP offers members indirect support via funded services (with a limit of $50k per year per device project, with $5k to $15k on average) such as:
- Regulatory and business consulting
- Market analysis, competitive and landscape assessment
- Entrepreneur-in-residence
- Reimbursement strategies
- Prototype and product design development
- Manufacturing
- Sales and distribution, clinical validation plans
Direct member support extends to:
- Investment of non-dilutive grant funds directly into device projects
So how does this relate back to Avulux?
Avulux is focused on managing photophobia through its unique technology (which we’ll get to in a moment)—and pediatric patients are known to “present unique challenges” for physicians in diagnosing migraines (and discerning between other visual disturbances).
- In fact: 2023 research reported up to 18% of pediatric patients were in the emergency room due to migraine-related diagnoses.
“Migraine in children is often underdiagnosed and undertreated, despite the profound impact on development, education, and overall well-being," stated Juan Espinoza, MD, CTIP director and principal investigator.
He added that CTIP’s purpose lies in supporting innovations that offer non-invasive and effective solutions to improve the lives of pediatric patients—such as Avulux.
Alrighty, now let’s talk about Avulux.
Developed by Bradley J. Katz, MD, a neuro-ophthalmologist and scientist at the University of Utah John A. Moran Eye Center, this optical technology is based on research into specific light wavelengths and their impact on managing light sensitivity (photophobia).
As for the details: See here for a rundown on the preliminary research into how certain visible light wavelengths play a role in activating intrinsically photosensitive retinal ganglion cells (ipRGCs)—and, as a result, lead to the onset of migraines.
- And click here for a look at later research supporting an alternative light wavelength to improve migraine attacks—which helped support the development of Avulux’s tech.
And this research led to the development of Avulux?
Indeed. While a more in-depth and thorough overview of the science and development behind these lenses can be found here, the resulting product is: the Avulux Migraine & Light Sensitivity Lenses incorporating a patented precision lens technology.
What this tech does: Enables lenses to filter up to 97% of blue, amber, and red light (which trigger and worsen migraines) while still allowing over 70% of green light (found to actually help migraines) to provide migraine patients with photophobia relief.
What research has been done on this Avulux-based technology?
As we previously reported, three clinical studies investigated the lenses throughout their development stage.
- The first: Evaluated Avulux lenses’ ability to block light wavelengths of 480 nm versus lenses blocking at 620 nm.
- The second: Involved an updated Avulux lens that absorbed up to 97% of blue, amber, and red light (while allowing green light through).
- And the third: Sought to determine the Avulux lenses’ effectiveness and the amount of medication participants may require during a migraine attack while wearing the lenses.
See here for a highlights version of the positive findings for those first two studies (the third has no updates so far, according to Clinical Trials).
So how do these lenses compare to other light-blocking glasses?
See here for a few examples of these (including blue-light blockers).
The difference: Avulux has noted that, unlike its own lenses, those glasses only block a portion of harmful light from entering the eyes (among other drawbacks).
- See here for surprising findings detailing how blue-light glasses may not be as visually beneficial as once thought.
Let’s talk regulatory clearance.
Prior reports have stated that the Avulux lenses are the first to undergo clinical trial testing and "received FDA confirmation of classification to be marketed as general wellness tools.”
Gotcha. And how are they designed?
Available as readers, prescription-, and non-prescription glasses, the Avulux lenses are hard-coated, anti-scratch, and come in a variety of styles—each featuring the precision-tinted (lightly-tinted) lenses.
About the glasses: Each pair is custom-made and tailored to the wearer (with or without prescription lenses)—with virtual try-on options available prior to purchase (accessible via the OCHO app).
- And as a bonus: Avulux lenses can also be fitted into patients’ own frames.
So they’re already available for purchase?
They are! The lenses can be purchased through select eyecare providers (ECPs) and optical retailers within the following countries:
- United States
- Canada
- Australia
- New Zealand
- United Kingdom
As for pricing: Costs will vary depending on the type of frames/lenses purchased. However, they are FSA- and HSA-eligible (Avulux recommends connecting with a provider to learn more).