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• W2313331343 startingPage "1111" @default.
• W2313331343 abstract "In Brief Purpose: To report the safety of intravitreal ocriplasmin injection based on 2 Phase 3 clinical trials in patients with symptomatic vitreomacular adhesion/vitreomacular traction, including when associated with full-thickness macular holes. Methods: Safety analyses were based on 2 completed Phase 3 studies assessing intravitreal ocriplasmin injection. Adverse events (AEs), serious AEs, and suspected adverse drug reactions are reported. The authors also report AEs of special interest from 8 other completed Phase 2 studies and 2 ongoing studies. Results: A total of 465 eyes were injected with ocriplasmin (125 µg), and 187 eyes were treated with placebo injection in Phase 3 studies. Overall AE rate was 69.0% in the placebo group and 76.6% for ocriplasmin-treated patients. Most AEs were in the study eye, mild or moderate in severity, and transient. All suspected adverse drug reactions were ocular; the majority was nonserious, of mild intensity, and transient. Conclusion: Intravitreal ocriplasmin injection provides a generally well-tolerated pharmacologic treatment option for patients with symptomatic vitreomacular adhesion/vitreomacular traction, including when associated with full-thickness macular holes ≤400 µm in diameter. In 2 Phase 3 clinical trials, intravitreal ocriplasmin injection in patients with symptomatic vitreomacular adhesion/vitreomacular traction was generally well tolerated. Most adverse events were ocular, occurred in study eye, and were mild or moderate in severity and transient." @default.
• W2313331343 created "2016-06-24" @default.
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• W2313331343 date "2015-06-01" @default.
• W2313331343 modified "2023-09-27" @default.
• W2313331343 title "SAFETY PROFILE OF OCRIPLASMIN FOR THE PHARMACOLOGIC TREATMENT OF SYMPTOMATIC VITREOMACULAR ADHESION/TRACTION" @default.
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• W2313331343 doi "https://doi.org/10.1097/iae.0000000000000448" @default.
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