News|Articles|October 30, 2026

Comments from the FDA Advisory Committee meeting on SYD-101

Eye care providers urged FDA advisers to approve SYD-101, citing myopia’s lifelong risks, compounding gaps and STAR trial results.

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee met October 30 to review Sydnexis’ atropine sulfate ophthalmic solution 0.01% (SYD-101), a low-dose atropine drop proposed to slow myopia progression in children aged 3 years and older.¹ The meeting, which comes a year after the agency issued a complete response letter (CRL) in October 2025,² was held from 8:30 am-3 pm ET and was open to public.¹ During the oral presentation segment of the meeting, eye care providers, industry and advocacy organization leaders, and those affected by pediatric myopia diagnoses gave their comments virtually and in-person during the meeting urging for the authorization of SYD-101. Electronic and paper submissions of commentary were also submitted by dozens of eye care providers and organizations to be taken in consideration in part of the meeting.¹

In the CRL, the FDA acknowledged that the phase 3 STAR trial met its primary endpoint but concluded the data did not support effectiveness. Sydnexis then filed a formal dispute resolution request, and the agency agreed to convene the committee to discuss the company’s application, including the STAR findings.² With no FDA-approved pharmaceutical option currently available in the US for pediatric progressive myopia,² many clinicians rely on compounded formulations, making today’s discussion closely watched across eye care. Here are the key takeaways from the comments submitted for the meeting.

John Berdahl, MD

John Berdahl, MD, wrote in support of SYD-101, citing its safety, its efficacy results, and potential future glaucoma applications. He explained that myopia is a glaucoma risk factor that scales with severity, pointing to a meta-analysis showing myopia nearly doubles the odds of open-angle glaucoma and a 2021 analysis estimating roughly 20% higher risk with each additional diopter. Axial elongation stretches and thins the sclera and lamina cribrosa, weakening the optic nerve head, and myopic eyes are harder to diagnose and monitor. Comparing the case to glaucoma care, where each 1 mmHg of pressure lowering cuts progression risk by about 10%, the letter urged the committee to judge clinical meaningfulness in light of SYD-101’s safety: in STAR, the drug met its primary end point and slowed annual progression from -0.38 to -0.30 D per year, with the greatest benefit in younger children.

“The standard of care has already moved. The American Academy of Ophthalmology's technology assessment found that low-dose atropine, particularly 0.01%, offers a favorable balance of efficacy and safety, and eye care professionals across use compounding pharmacies around the country prescribe it today, which demonstrates the need. Children deserve an FDA approved manufactured drug with clear data they can trust,” Berdahl stated in the letter.

Magdalena Stec, OD, FAAO

Magdalena Stec, OD, FAAO, wrote in strong support of FDA approval for SYD-101 to treat pediatric myopia. Drawing on her work with hundreds of children each month as a clinician, educator, and researcher, she emphasized the importance of meaningful treatment options for individualized, evidence-based care.³

“My belief in the importance of treatment options is also deeply personal,” she wrote in the letter. “Recently, I lost someone very close to me to a progressive neurodegenerative disease. Experiencing this loss as a healthcare professional, caregiver, and daughter was devastating, particularly in the face of limited treatment options. This experience reinforced my conviction that access to treatment options matters—not only to clinicians, but also to the patients and families who place their trust in us.”³

She argued that FDA approval gives clinicians and families greater confidence in available therapies, and she urged the agency to approve the drug as an additional option so that clinicians and parents can make informed decisions together, which she called central to patient-centered care.³

Vance Thompson, MD

In his letter, Vance Thompson, MD, described pediatric progressive myopia as a disease of abnormal eye growth rather than a benign refractive error. Without intervention, the letter noted, progression raises the lifetime risk of retinal detachment, myopic maculopathy, myopic choroidal neovascularization, and early-onset glaucoma and cataracts, all of which can cause permanent vision loss. The physician described the anxiety of parents who hear at each visit that their child’s vision has worsened, and the helplessness of having no FDA-approved treatment to offer, recalling a highly myopic patient in their 30s whose retinal detachment could not be repaired. Because SYD-101 can be started earlier than options such as orthokeratology or multifocal contact lenses, when myopia typically progresses fastest, the ophthalmologist argued it could reduce the risk of serious complications for decades.

“The approval of SYD-101 would represent more than a new treatment — it would be a transformative tool in preventing future vision loss, improving public health outcomes, and empowering physicians and families to act early against this disease,” Thompson stated in his letter. “Since treatment SYD-101 can start at an earlier age than other treatments like orthokeratology or multifocal contacts we have a shot at helping these children at their most vulnerable tender years when myopia is typically progressing at its fastest rate. And because treatment would be initiated in those young pediatric years, the benefits extend across a patient’s lifetime, reducing the risk of serious and costly ocular complications for decades to come.”

Erin Tomiyama, OD, PhD, FAAO

Erin Tomiyama, OD, PhD, FAAO, who leads a myopia control clinic in an academic setting, urged FDA approval of SYD-101, citing her own published research on compounded low-dose atropine. That work found significant variability in compounding practices across pharmacies, including formulation, storage recommendations, and beyond-use dating, and a follow-up study showed that samples from several US compounding pharmacies lost concentration and rose in pH within 30 days of opening, indicating degradation. Tomiyama stated that the findings from this research “highlight the broader challenges associated with compounded ophthalmic medications and underscore the need for standardized, regulated options.”

“This issue also carries a significant emotional weight for families,” Tomiyama continued in her letter. “I regularly speak with parents who are navigating difficult decisions with deep concern for their children’s visual health. Many fear what rapid myopia progression could mean for their child’s future — not just glasses, but real risks of retinal detachment, glaucoma, and vision impairment later in life. An FDA-approved formulation of low-dose atropine would offer these families a more reliable, accessible, and reassuring option. The clinical data support its effectiveness. The need in practice is clear. And the families we serve are urgently looking for solutions they can trust.”

Nimesh A. Patel, MD

Nimesh A. Patel, MD, also urged the committee to approve SYD-101, saying the available safety and efficacy data suggest it could meaningfully slow myopia progression and axial elongation. Patel described pathological myopia as a leading and growing cause of irreversible vision loss worldwide, with progression sharply raising the risk of retinal detachment, myopic choroidal neovascular membrane, and myopic macular atrophy.

Drawing on his subspecialty in retinal detachment, he described the heavy burden on young patients, some of whom he has treated with more than 4 surgeries in a single year, each requiring face-down positioning, time away from school, and activity restrictions, along with frequent secondary procedures and repeated postoperative methotrexate injections that strain families, especially those far from retinal centers.

“For myopia management, current options are also inadequate,” Patel wrote in his letter. “Many ophthalmologists and optometrists must rely on compounded atropine formulations to address a condition that has reached epidemic proportions in children. Access to these preparations is inconsistent, and concerns regarding quality and safety lead some providers to refrain from prescribing them. As a result, many children who could benefit from atropine therapy are not offered the most effective evidence-based options available.”

Vittorio Mena, OD, MS

In his letter, Vittorio Mena, OD, MS, noted that the American Medical Association now recognizes myopia as a chronic progressive disease and that progression raises the risk of myopic maculopathy, early cataracts, glaucoma, and retinal detachment, which carry significant health and financial costs. He argued that FDA approval would reassure parents about the safety of the formulation, and he pointed to the burdens families face without it: compounded atropine is usually not covered by insurance, stronger prescriptions mean costlier glasses each year, and children who lose, break, or refuse to wear glasses because of bullying may struggle in class and risk injury in sports. “As a doctor who sees a lot of patients for sports vision, I see the patient burden of progressive myopia every day,” Mena wrote in his letter.

Citing the phase 3 STAR trial, he highlighted results in fast progressors, in whom SYD-101 reduced progression by more than 75% in year 1 and well over 50% by year 3, along with the trial meeting its primary and secondary endpoints in the full population. In his view, the question is not whether SYD-101 works but whether clinicians will have access to the safest, highest-quality form of low-dose atropine.

Chris Wroten, OD

An early adopter of myopia control and a high myope himself, Chris Wroten, OD described myopia in his letter as an epidemic with major costs to the healthcare system and rising risk of retinal disease and glaucoma with each additional diopter. He noted that atropine has long been shown to slow myopia progression, but compounded formulations vary widely in quality and cost, putting the therapy out of reach for vulnerable patients who also can’t afford specialty glasses or contact lenses. A standardized, commercially manufactured option, Wroten said, would improve care and could lead to insurance coverage that expands access. He pointed to the STAR trial meeting its primary and key secondary endpoints with no FDA safety, quality, or manufacturing concerns, and to progression reductions of 76%, 65%, and 57% at 12, 24, and 36 months in fast progressors.

Wroten also shared that his own children, treated with myopia control from toddlerhood, ended up with roughly 60% to 67% less myopia than he and his wife. “Fortunately, my wife and I had both the means to intervene on our children’s behalf and the ability and knowledge to monitor their progression and adjust therapy as needed,” Wroten stated in his letter. “All children should have similar opportunities, so I would strongly urge you to thoroughly evaluate the clinical data at your disposal, and ensure eye care providers and their patients have access to safe, effective, commercially manufactured atropine.”