Ophthalmic topical stories

Oct 30, 2026

FDA advisory committee reviews SYD-101 atropine eye drops for pediatric myopia

An FDA advisory committee convened on October 30 to discuss SYD-101, a low-dose atropine eye drop for slowing pediatric myopia that the FDA declined to approve last year. The treatment met its primary endpoint in a phase 3 trial, but the FDA determined the overall results were insufficient for approval.

Oct 30, 20261 source

Top claims

▪Acting committee chairperson Michael X. Repka stated that while the SYD-101 trial was positive, it lacked the robust outcome required for FDA approval.
▪Eye care practitioners advocate for FDA approval of SYD-101 to establish a standardized, FDA-regulated atropine product for pediatric myopia treatment to replace compounded alternatives.
▪Nineteen people, including five optometrists and 10 ophthalmologists, spoke in favor of approving SYD-101 during an open public hearing at the advisory committee meeting.

Subtopics

Child health1 Clinical trial endpoints1 Compounding pharmacies1 Drug development1 Drug Policy, Pricing & Approval1 FDA drug approval1

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