CONF-2025-EASD-Vilsboll-NAION — EASD 2025: Vilsbøll Semaglutide NAION Incidence (Late-Breaking)

[DRAFT — authored 2026-04-19. Conference context web-verified via EASD congress materials, Novo Nordisk slide deck, and WHO ACSoMP May 2025 statement 2026-04-19.]

Meeting Metadata

Conference: 61st Annual Meeting of the European Association for the Study of Diabetes (EASD 2025)
Dates: September 15-19, 2025
Location: Vienna, Austria
Session type: Late-Breaking Abstract (LBA-25-3912-EASD)
Format: Oral presentation

Presentation

Presenter / Corresponding: Prof. Tina Vilsbøll, MD, DMSc (Steno Diabetes Center Copenhagen; senior author on multiple GLP-1 clinical programs)
Title: Incidence of non-arteritic anterior ischaemic optic neuropathy in patients treated with semaglutide: pooled analysis of Phase 2, 3, and 4 trials
Sponsor: Novo Nordisk (pooled-trial-data analysis)

Key Findings as Presented

Data source: Pooled exposure data from all Phase 2, 3, and 4 semaglutide trials (across Ozempic, Wegovy, Rybelsus programs)
Cases identified: All 3 ophthalmologist-confirmed NAION cases in the pooled dataset were in semaglutide-treated participants; 0 cases in liraglutide-treated participants
Statistical interpretation: Non-significant P values for the binary tests (GLP-1 RA vs placebo; semaglutide vs placebo) — the trial-pooled dataset is under-powered to exclude a class or agent-specific signal given the low event rate
Clinical context: Presented alongside the pharmacovigilance-scale evidence (Hathaway single-center cohort, Danish/Norwegian national cohort, Lakhani 180-country pharmacovigilance) that yielded signals the trial-pooled analysis cannot either confirm or refute at trial-scale n

Regulatory Context (May-June 2025)

WHO ACSoMP (May 2025): Advisory Committee on Safety of Medicinal Products evaluated the aggregate evidence and concluded that the Risk Management Plan for semaglutide should be revised to include NAION as a potential risk
EMA PRAC (June 2-5, 2025): Formally classified NAION as a "very rare" side effect of semaglutide medicines (up to 1 in 10,000 patients); product information updated in EU (REG-EMA-PRAC-Semaglutide-NAION-2025 – EMA NAION Very Rare)

The Vilsbøll EASD 2025 presentation is the clinical-trial-pooled corroboration presented after the EMA/WHO regulatory actions — it neither confirms nor refutes the pharmacovigilance-scale signal, and Vilsbøll frames it as such.

Cross-Links to Full Publications / Reference Evidence

PMID-38958939 – Hathaway NAION Cohort — Hathaway JT et al. JAMA Ophthalmol 2024;142:732-739 (seminal single-center cohort)
PMID-39696569 – Danish Norwegian NAION Cohort — population-scale Danish/Norwegian cohort
PMID-40383360 – Lakhani 180 Countries GLP-1 Ocular Events — 180-country pharmacovigilance with class-differentiation (no tirzepatide NAION signal at same threshold)
REG-EMA-PRAC-Semaglutide-NAION-2025 – EMA NAION Very Rare — EMA regulatory outcome

Relevance to Module 5

Lesson 5.2 Section 4 (Adverse Effects / NAION) — Vilsbøll EASD 2025 presentation referenced as part of the triangulated evidence framework
Semaglutide profile NAION Contraindications & Safety section

Sources

Novo Nordisk / Vilsbøll EASD 2025 NAION slide deck (PDF)
WHO ACSoMP statement on semaglutide NAION (June 2025)
EASD 2025 Late-Breaking Abstract LBA-25-3912-EASD

Orchestrator Notes

CONF note cross-linked to regulatory and pharmacovigilance references — not an orphan.
Vilsbøll is a senior GLP-1 clinical-science figure; presentation carries substantial weight in the NAION conversation even with its stated statistical limitations.
Verified 2026-04-19.

CONF-2025-EASD-Vilsboll-NAION