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: acute vision loss -- adverse event -- dyschromatopsia -- electroretinogram -- intravitreal injection -- lens subluxation -- macular hole -- ocriplasmin -- symptomatic vitreomacular adhesion -- vitreomacular traction; Retina -- Diseases -- Periodicals; Retinal Diseases; Vitreous Body; 617.735
• DOI: 10.1097/IAE.0000000000000448
• Languages: English
• ISSNs: 0275-004X

Abstract

Abstract : 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 µ 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. 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 µ m in diameter. Abstract : 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.Supplemental Digital Content is Available in the Text.