SAFETY PROFILE OF OCRIPLASMIN FOR THE PHARMACOLOGIC TREATMENT OF SYMPTOMATIC VITREOMACULAR ADHESION/TRACTION. Issue 6 (June 2015)

• Record Type: Journal Article
• Authors: Kaiser, Peter K.; Kampik, Anselm; Kuppermann, Baruch D.; Girach, Aniz; Rizzo, Stanislao; Sergott, Robert C.
• Is Part Of: Retina. Volume 35:Issue 6(2015:Jun.)
• Publication Date: 2015-06
• Subjects: Retina -- Diseases -- Periodicals; Retinal Diseases; Vitreous Body; 617.735
• DOI: 10.1097/IAE.0000000000000448
• Languages: English
• ISSNs: 0275-004X

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <sec> <title>Purpose:</title> <p>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.</p> </sec> <sec> <title>Methods:</title> <p>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.</p> </sec> <sec> <title>Results:</title> <p>A total of 465 eyes were injected with ocriplasmin (125 <italic>µ</italic>g), 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.</p> </sec> <sec> <title>Conclusion:</title> <p>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 <italic>µ</italic>m in diameter.</p> </sec> </abstract>