• Peter K Kaiser, Anselm Kampik, Baruch D Kuppermann, Aniz Girach, Stanislao Rizzo, and Robert C Sergott.
• *Department of Ophthalmology, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; †Department of Ophthalmology, Ludwig Maximilians University, Munich, Germany; ‡Retina Service, Gavin Herbert Eye Institute, University of California, Irvine, California; §NightstaRx Ltd., London, United Kingdom (formerly of ThromboGenics NV); ¶Santa Chiara Hospital, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy; **Neuro-Ophthalmology Service at Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania; and ††Optic Nerve Research Center, Claymont, Delaware.
• Retina (Philadelphia, Pa.). 2015 Jun 1; 35 (6): 1111-27.

PurposeTo 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.MethodsSafety 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.ResultsA 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.ConclusionIntravitreal 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.

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