Table 5_Safety signals of perfluorohexyloctane ophthalmic solution in patients with dry ey

92 adverse event reports for perfluorohexyloctane ophthalmic solution were analyzed from the FDA Adverse Event Reporting System (FAERS) database from Q4 2023 to Q4 2024. The study by Zhengtai Sun, posted in 2026, employed four disproportionality analysis methods to identify potential safety signals. The median time-to-onset for reported adverse events was 2 days.

Use Cases

• Identify potential safety signals for a novel ophthalmic solution based on disproportionality analysis methods mentioned in the description.
• Analyze the nature and timing of reported adverse events, such as product delivery issues and eye irritation, from real-world pharmacovigilance data.
• Compare safety profiles of dry eye disease therapies based on adverse event reports from the FAERS database.
• Support clinical risk management and long-term treatment strategies for dry eye disease using evidence from adverse event reporting.

Strengths

• Analysis is based on 92 adverse event reports from the FDA Adverse Event Reporting System (FAERS).
• The study employs four established disproportionality analysis methods (ROR, PRR, BCPNN, MGPS).
• Provides a specific median time-to-onset of 2 days for reported adverse events.

Limitations

• The dataset is very small at 16.3 KB, indicating limited scope and a small number of reports.
• Column-level documentation is absent; field semantics must be inferred after download.
• Data freshness should be verified as the last update date is in the future (2026-05-28).

Provenance

Source

FDA Adverse Event Reporting System (FAERS) database.

Collection Method

Retrospective pharmacovigilance study using disproportionality analysis.

Time Range

Fourth quarter of 2023 through the fourth quarter of 2024.

Freshness

Last updated 2026-05-28 04:48:10; freshness should be verified.