The recent FDA decision on SYD-101 has implications on the eye care industry.
November 17, 2025
Ashley Wallace Tucker, OD, FAAO, FSLS
When the FDA issued a Complete Response Letter (CRL) to the makers of SYD-101, the low-dose atropine formulation tested in the landmark Phase III STAR trial, the decision sent ripples through the eye care community—especially for myopia management enthusiasts like me. The data had met its primary endpoint, safety was well established and clinicians across the country had been eagerly anticipating the first FDA-approved pharmaceutical therapy for Pediatric Progressive Myopia (PPM). Instead, the CRL questioned the magnitude of effect, leaving doctors and families once again without an approved option for a condition that is quietly reaching epidemic proportions.
The Risks of PPM
Pediatric progressive myopia is not a simple refractive inconvenience. It is a chronic, progressive ocular disease characterized by pathological elongation of the eye. Left unmanaged, it increases the lifetime risk of retinal detachment, primary open angle glaucoma, myopic macular degeneration and irreversible vision loss. Each year, the prevalence of childhood myopia rises, and yet, in the U.S., there remains no FDA-approved pharmaceutical therapy to slow its course.
The Ins and Outs of Compounded Low-Dose Atropine
In this therapeutic void, clinicians have done what we must, which is rely on compounded low-dose atropine. In thousands of practices, we prescribe it for hundreds of children every year because we have witnessed it work time and time again. Compounded atropine has been shown to slow myopia progression and stabilize axial elongation. We see it in the data, in the refractions and in the relieved expressions of parents whose children no longer have rapidly progressing prescriptions.
However, the reality is that compounded medications vary in concentration, sterility and stability. There is no FDA oversight, no national standard and no guarantee of equivalency from one pharmacy to another. In every other area of pediatric medicine, such variability would be unacceptable. Our patients with progressive myopia deserve the same level of safety, consistency and quality assurance that is expected for any other chronic condition.
That is what made SYD-101 and the STAR trial so promising. The study was the largest, most diverse myopia control trial ever conducted, following 842 children for three years. It met its primary endpoint and reinforced what clinicians have observed for years: low-dose atropine is both safe and effective. The treatment was well tolerated and delivered clinically meaningful results.
Approval Abroad
Yet while U.S. regulators hesitate, children continue to progress, and Europe has already approved SYD-101 under the brand name Ryjunea. The contrast is difficult to ignore. Our profession is left frustrated not by science, but by process.
We are not asking for shortcuts. Instead, we are asking for access. An FDA-approved formulation would provide standardized dosing, validated stability and the oversight our patients deserve.
Education is A Must
Until that becomes reality, clinicians must continue to educate families, monitor outcomes carefully and advocate for an approved pharmaceutical therapy. Every delay leaves children at risk of irreversible elongation and future vision loss.
The silence of disapproval and dismissal by the FDA is deafening.
