FDA's Dermatologic and Ophthalmic Drugs Advisory Committee meets hybrid — in person at the agency's White Oak campus and by webcast — , 8:30 a.m.–3 p.m. ET, to review New Drug Application 219694 for atropine sulfate ophthalmic solution, 0.01%, proposed to slow the progression of myopia in children.
Dates and format
- Date: 30 October 2026, 8:30 a.m.–3 p.m. ET
- Format: hybrid — in person at FDA White Oak, plus online teleconferencing/video access; open to the public
- Docket: FDA-2026-N-10606, established for public comment
- Organizer: FDA Center for Drug Evaluation and Research, Dermatologic and Ophthalmic Drugs Advisory Committee
What it covers
The Committee takes up New Drug Application 219694 for atropine sulfate ophthalmic solution, 0.01%, with a proposed indication for slowing the progression of myopia in children age 3 and older — a pediatric ophthalmic use with no directly comparable approved product today. Independent trade and financial press coverage names the sponsor as Sydnexis, developing the product under the name SYD-101, and confirms the same 30 October meeting date announced by the company itself.
Who should attend
Regulatory affairs and clinical teams working on pediatric ophthalmic or dermatologic drug submissions, medical affairs staff tracking precedent for pediatric efficacy endpoints, and anyone following how FDA evaluates a first-in-category use in children. FDA's Pediatric Advisory Committee covers pediatric drug safety more broadly, and the Microbiology Devices Panel's pathogen-agnostic sequencing meeting shows the same committee structure applied to devices.
Frequently asked questions
When does FDA's Dermatologic and Ophthalmic Drugs Advisory Committee meet on atropine sulfate?
30 October 2026, 8:30 a.m. to 3 p.m. Eastern Time, held hybrid at FDA's White Oak campus and by webcast.
What is the Committee reviewing?
New Drug Application (NDA) 219694 for atropine sulfate ophthalmic solution, 0.01%, proposed to slow myopia progression in children 3 years of age or older. Independent press coverage identifies the sponsor as Sydnexis (SYD-101).
Can the public attend or comment?
Yes. The meeting is open to the public, in person or online, and FDA established public docket FDA-2026-N-10606 for written comment.
Is there a fee to attend?
No stated fee. FDA advisory committee meetings are free and open to the public.
Where can I watch the webcast?
FDA states it will post background material and the live webcast link no later than two business days before the meeting on its advisory committee calendar page.
Sources & further reading
- Federal Register / FDA. Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments — NDA 219694, Atropine Sulfate Ophthalmic Solution, 0.01%, 09/25/2026. federalregister.gov
- FDA. Advisory Committee Calendar — October 30, 2026: Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement. fda.gov
Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration rather than a direct fetch, because this session's network egress could not reach federalregister.gov or fda.gov directly — confirm dates and access with FDA before making plans. Last verified 26 September 2026.
