David G. Hunter is president of the American Association for Pediatric Ophthalmology and Strabismus, a professor of ophthalmology at Harvard Medical School and co-founder of the medical device company Rebion.
I remember the day I first put on eyeglasses at age 8. Stepping out of the optical shop, I saw individual leaves on trees and blades of grass with shock and wonder — details that had been invisible blurs just moments before because I had developed myopia. That is, I had become nearsighted.
What I didn’t understand then was that myopia isn’t just nearsightedness requiring glasses — it’s a degenerative disease. It was only when my mother went blind from myopic macular degeneration that I fully grasped the stakes. A myopic eye elongates, stretching that delicate retinal tissue and dramatically increasing the lifetime risk of retinal detachment, macular degeneration, cataracts and glaucoma. Today, 40 percent of Americans are affected by myopia — nearly double the rate from 30 years ago. By 2050, nearly 60 percent of Americans could be affected. The cause of this exponential increase is still unknown, although some researchers suggest it could be linked to more screen usage and less time outdoors.
As I’m a pediatric ophthalmologist, parents whose children have myopia all ask me the same question: “Can you stop this from getting worse?” And I must explain that while I can prescribe off-label treatments, the Food and Drug Administration has kept a proven pharmaceutical option out of reach — despite telling the manufacturer exactly what evidence it needed and then rejecting that very evidence when it was delivered.
The FDA recently released its October 2025 review letter to Sydnexis regarding SYD-101, a low-dose atropine treatment for pediatric myopia. The letter confirmed what the company had been told from the outset: Two clinical trials were not necessary. One large, well-designed trial would suffice. So, Sydnexis conducted the largest global clinical trial ever completed in pediatric myopia, following over 800 children for three years. The trial met all pre-stated criteria for effectiveness and satisfied every safety requirement the FDA had established.
Yet the FDA rejected the application. Though the agency acknowledged that there were no safety concerns and the improvement in progression met the predetermined criteria, they decided that they needed to see even more improvement than originally specified. They concluded that the data did not support effectiveness because children prescribed low-dose atropine would still have to wear glasses.
Low-dose atropine drops have long been available for purchase in East Asia and India, and children in the European Union can now receive pharmaceutical-grade SYD-101, approved there last June. American children cannot. Instead, they rely on unregulated compounds while waiting for the FDA to reconsider a decision that appears to contradict its own guidance.
This decision has consequences far beyond one drug application. When I diagnose progressive myopia and prescribe drops, I must send families to specialty pharmacies that convert existing medications into custom, unofficial formulations (in this case, diluting the atropine to lower concentrations without FDA oversight). Families must pay out of pocket (insurance rarely, if ever, covers it) for these formulations, which vary in quality depending on the pharmacy and even the pharmacist. A peer-reviewed study found that variability in the production of compounded low dose atropine may affect quality and efficacy.
The implications extend beyond myopia treatment. The message to companies developing any pediatric therapies is troubling: Meeting the FDA’s explicit guidance may not be enough for approval. When regulatory expectations can shift after years of clinical trials and hundreds of millions of dollars in investment, innovation suffers. Investors think twice before funding pediatric research. Promising treatments languish. And children lose access to potentially life-changing care.
The FDA serves a critical role in protecting public health, and rigorous standards are essential. But when an agency provides explicit guidance, conducts ongoing reviews during clinical development, and then rejects an application that meets its own stated criteria, something has gone wrong. The FDA must establish consistent, objective standards for evaluating pediatric treatments so that future innovators aren’t left to navigate an unpredictable approval process.
Until then, I’ll continue prescribing custom-mixed atropine formulations of varying quality to children whose vision is deteriorating — knowing that a rigorously tested alternative exists but remains out of reach. My patients deserve better. American health care innovation deserves better. And the FDA’s own credibility demands better.
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