The Epidemic of Myopia in Kids - Is There A Rainbow?
This post is sponsored by Sydnexis; however, all viewpoints, analyses, and conclusions expressed are solely my own. Sydnexis exercised no editorial control over this content and did not review the post prior to publication.
The Myopia Epidemic
If you’ve followed my work on myopia (nearsightedness) closely, you know that we are in the middle of a global myopia epidemic. What exactly does that mean? That rates of nearsightedness are increasing exponentially across the world. By 2050, half the world’s population is predicted to be myopic.1 And, in some Asian countries, like Singapore, myopia rates are already approaching 80-90% in high school seniors.2 More children are becoming nearsighted and at a younger age. In 1983, the average age of onset of myopia worldwide was 11 years old. In 2000, the average onset of myopia had decreased to just 8 years old.3
So why does this matter? Nearsightedness isn’t a real disease after all - it just means you need glasses right? This is one of the most common misconceptions of myopia. Myopia isn’t just about poor eyesight - at high enough powers, myopia is actually categorized as a disease, called pathologic myopia or myopic degeneration. High myopia (-6.00 D or higher) carries with it risks to the visual and ocular health of the eye. High myopes are 39 times more likely to develop a retinal detachment than non-myopes. About 1 in 4 individuals with high myopia will develop myopic maculopathy, a potentially blinding condition, whereas it is exceedingly rare in non-myopes. And even something as common as cataracts is 2.5 times more likely in myopic individuals. These are all vision threatening, potentially blinding consequences. They occur because myopic eyes are longer than non-myopic eyes. As a result, the retina and corresponding structures are stretched more thin, leading to breaks in the retina and/or macula. These are serious issues which require emergency surgery and even with that, the visual outcome can be poor.
Why Are Kids Becoming So Nearsighted?
Why are kids becoming so nearsighted so quickly? Genetics doesn’t change in 1 or 2 generations, that kind of evolutionary change takes much longer. So, we must look at what HAS changed rapidly in the past 30 years. Many of the answers lie in modifiable lifestyle risk factors.
More Near Work - Near work is classified as anything up close. This includes reading, writing, coloring, sewing. But, now with schools emphasizing digital education, kids are being introduced to screens at an earlier age. In the past, kindergarteners and first graders were taught by teachers with experiential learning or at the dry erase board. Now they’re all given ipads (mine were) or chrome books, devices which require children’s eyes to focus up close, or accommodate for longer periods of time.
Less Outdoor Time - Outdoor time has repeatedly been shown to decrease the progression of myopia in kids. Just 2 hours/day has been demonstrated in studies in China, Singapore, and Australia helps slow or even prevent myopia in children. Kids today just don’t spend as much time outdoors as in years past. Several large cross sectional and cohort studies have shown that children living in urban environments have a significantly higher prevalence of myopia than their counterparts in rural environments, even when controlling for ethnicity and other confounding variables.(4,5)
Decreasing the risk of nearsightedness in our kids starts with the above. They are free, not easy by any stretch, but cost nothing to institute. But what else can we do as parents?
I’ve been vocal about sharing my own journey not just as a physician who specializes in treating this disease (and yes it is a disease) but as a mother whose own children are at high risk. My husband is a high myope as are several members of his family. Many have unfortunately dealt with consequences of high myopia - retinal detachments, retinal breaks and bleeding in the retina. I wanted to be as proactive as possible to minimize these risks for my own children and I turned to low dose atropine to do so.
The Answer: Low Dose Atropine
Low-dose atropine is one of the most studied and effective treatments for slowing childhood myopia progression. Currently it is only available as a compounded eye drop, which means only a few select pharmacies mix the atropine, diluting it to the appropriate dosage and then offering to ship it to patients. The drop is used once every night and the studies have consistently shown:
Atropine does not stop eye growth completely.
It slows down the rate of elongation in most children.
When you stop the drops, the prescription may increase, but NOT dramatically or dangerously if the dose was low. Also, the rebound effect is:
Mild with very low doses (0.01% or 0.025%)
Stronger with higher doses (0.5% to 1%) but those are not commonly used anymore.
Millions of children worldwide are safely using 0.01–0.05%.
This treatment is recommended in:
-Singapore National Eye Centre
-American Academy of Ophthalmology (AAO)
-European Society of Ophthalmology
-WHO Myopia Report
Studies have also recently shown that low dose atropine can even be used in pre-myopic children to decrease or even prevent myopia. What is pre-myopia? It’s when a child is not nearsighted, but is headed in that direction. During a comprehensive eye exam with your pediatric ophthalmologist or optometrist, we perform a cycloplegic refraction - that is an objective measurement of your child’s glasses prescription. Most children should be hyperopic (plus power) and there are rough tables for how plus a chld should be at certain ages. Typically, children outgrow this plus power, stabilizing at 0 around age 18. But, if a child measures less plus than I would expect, I can approximate based on their family history, their risk factors (time spent indoors, on near work etc) that they might be at a higher likelihood of developing myopia in the future. (6,7)
I believe in low dose atropine. I’ve treated over 300 kids in my practice with it, many of whom are at high risk for myopia progression. And I treated all 3 of my kids with it prophylactically to prevent myopia. But, for now, the only avenue we have for receiving the drop is through a compounding pharmacy. Having an FDA approved option would help increase equity for all children to have access to this drop should they need it. So I was excited when I learned of a company (Sydnexis) in the midst of FDA trials for low dose atropine. Here was a solution - a way to create a stable formulation of low dose atropine, where we could be 100% certain of the exact concentration we were administering to our patients. So what happened?
The Rain aka The FDA Approval Process
The FDA recently issued a regulatory letter to Sydnexis about their low dose atropine formulation SYD-001 and decided not to approve the drop. The trial - the SYD--001 STAR trial is one of the largest on myopic children conducted - with over 850 children. The study actually met its primary end point, that’s the main outcome measured in a clinical trial which determines its efficacy, as well as its secondary endpoint. So, SYD-001, the low dose atropine formulation was found to be clinically effective AND it didn’t have any safety concerns. Yet it was still not granted automatic approval. The American Association of Pediatric Ophthalmology & Strabismus came out in support as well, pointing out that the drop has marketing approval in Europe and other countries.
So does this mean that low dose atropine doesn’t work if the FDA didn’t grant it approval? Absolutely not. There are literally hundreds of studies and meta-analysis demonstrating the effectiveness of low dose atropine in stabilizing myopia progression in children.Unfortunately the FDA was not transparent with their decision. It’s actually pretty baffling because the FDA actually reviews and provides guidance on the chosen endpoints during the entire FDA process to ensure they are appropriate for measuring the treatment's main effect. And, then for some reason, the endpoints they helped choose were met, yet they rejected SYD-001 anyway.
I can’t help but wonder if the FDA does not understand the scope and magnitude of progressive myopia in kids. This is not just a vision disorder. It carries with it real risks and potential visual impairment. Unfortunately, the medication division is separate from the medical device division. The device divisions seems to understand the importance - they approved Coopervision’s Misight Contacts in 2020 and Stellest lenses just this past October, both methods for stabilizing nearsightedness. I can only hope (the rainbow!) that the drug division will conclude similarly soon.
The Rainbow
I will continue using low dose atropine through the compounding pharmacies in the interim. But I am hopeful that SYD-001 will eventually get approved by the FDA. Compounded low dose atropine has its limitations. Variability in concentration, shelf life stability and intolerance of certain vehicles make it less than ideal. In addition, many parents are deterred when they hear that low dose atropine is not yet FDA approved. Having an FDA approved option will enhance the trust (and therefore conversion and compliance) of parents and will also serve to persuade my colleagues who have been waiting for this version before prescribing low dose atropine. When that happens, then all children will be able to access to the care that they deserve.
