From our Editorial Board: Comments from the FDA Advisory Committee meeting on SYD-101

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. Of those watching and commenting were the Eye Care Network’s editorial board members. Here are the key takeaways from the comments they submitted for the meeting.

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

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.”

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.”

References

1. US FDA. October 30, 2026: Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement. Accessed October 30, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/october-30-2026-dermatologic-and-ophthalmic-drugs-advisory-committee-meeting-announcement-10302026

2. Joy J. FDA Advisory Committee to review SYD-101 for pediatric myopia October 30. Optometry Times. September 24, 2026. Accessed October 30, 2026. https://www.optometrytimes.com/view/fda-advisory-committee-syd-101-pediatric-myopia-october-30

3. Regulations.gov. Comment from Dr Magdalena Stec, OD, FAAO. October 13, 2026. Accessed October 30, 2026. https://www.regulations.gov/comment/FDA-2026-N-10606-0039

4. Regulations.gov. Comment from Erin Tomiyama, OD, PhD, FAAO. October 7, 2026. Accessed October 30, 2026. https://www.regulations.gov/comment/FDA-2026-N-10606-0003

5. Regulations.gov. Comment from Dr Vittorio Mena, OD. October 13, 2026. Accessed October 30, 2026. https://www.regulations.gov/comment/FDA-2026-N-10606-0036

6. Regulations.gov. Comment from Chris Wroten. October 19, 2026. Accessed October 30, 2026. https://www.regulations.gov/comment/FDA-2026-N-10606-0044