FDA advisory panel revisits low-dose atropine drop for kids with myopia

An FDA advisory committee convened on October 30 to take another look at SYD-101 (atropine 0.01%, Sydnexis), a low-dose eye drop designed to slow the progression of myopia in children. The FDA had previously declined to approve it, citing concerns that the overall results showed "limited to no clinical benefit" — despite the drug meeting its primary endpoint in a phase 3 trial. Sydnexis responded with a formal dispute resolution request and made its case before the agency's dermatologic and ophthalmic drugs advisory committee.

The hearing drew strong support from the eye care community, with 19 speakers — including 10 ophthalmologists and 5 optometrists — advocating for approval. Clinicians highlighted a key gap: atropine is already widely prescribed off-label for myopia, but sourced from compounding pharmacies with inconsistent quality and no insurance coverage. SYD-101, they argued, would provide a standardized, reliable option.

Key Takeaways:

• SYD-101 met its phase 3 primary endpoint, but the FDA flagged concerns about borderline statistical significance and clinical meaningfulness
• Nearly 60 written public comments were submitted to the FDA in support of approval
• Major medical societies urged the FDA to approve the medication

Why it matters: Pediatric myopia is a growing global concern, and U.S. clinicians currently lack an FDA-approved treatment. Approval of SYD-101 could fill a critical gap, replacing inconsistent compounded formulations with a standardized, insured option for children.