Ocular Adverse Events in Sphingosine-1-Phosphate Receptor Modulators Based on 98,843 Reports
Among 98,843 primary-suspect reports, 8,812 (8.9%) indicated ocular adverse events. Notably, macular edema was strongly linked to sphingosine-1-phosphate receptor modulators, especially fingolimod, with a median onset of 93.0 days. The class-level reporting odds ratio for ocular events was 29.47, rising to 43.85 for MS-specific cases.
- Tags
- #MSResearch
- Most relevant to
- —
- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
This analysis emphasizes the occurrence of ocular events with S1P receptor modulators, highlighting macular edema as a significant concern for clinicians and patients.
What this does not prove
The findings are limited by sparse data for newer agents and residual confounding, which might affect the interpretation.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- 98843 · primary-suspect reports
- Randomised
- No
- Controlled
- No
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- 2026-09-25
- Evidence reviewed
- Abstract only
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
- Primary evidenceOcular safety signals of sphingosine-1-phosphate receptor modulators in postmarketing surveillance. ↗DOI: 10.3389/fphar.2026.1908773
Supporting passages (12)
sample size98,843 primary-suspect reports
sample size basisprimary-suspect reports
randomizedNo
controlledNo
interventionBACKGROUND: Sphingosine-1-phosphate (S1P) receptor modulators are used for immune-mediated diseases, and macular oedema is an established ocular adverse effect.
comparatorIn indication-restricted multiple sclerosis analyses, the association remained elevated versus all non-S1P disease-modifying therapies (ROR, 43.85; 95% CI, 35.75-53.78), while ulcerative colitis/inflammatory bowel disease analyses were sparse and exploratory.
primary endpointBACKGROUND: Sphingosine-1-phosphate (S1P) receptor modulators are used for immune-mediated diseases, and macular oedema is an established ocular adverse effect.
findingsRESULTS: The primary cohort included 98,843 primary-suspect reports, of which 8,812 (8.9%) were ocular, representing 12,088 unique ocular report-PT pairs.
findingsMedian time to onset was 93.0 days for fingolimod and 15.5 days for siponimod.
limitationsSparse data for newer agents and residual confounding limit comparative interpretation.
limitationsSparse data for newer agents and residual confounding limit comparative interpretation.
publication datePublication date: 2026-09-25
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.