title: Safety profile of ocriplasmin for the pharmacologic treatment of symptomatic vitreomacular adhesion/traction.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors: *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.
authors: Peter K
authors: PK
authors: Kaiser
authors: Anselm
authors: A
authors: Kampik
authors: Baruch D
authors: BD
authors: Kuppermann
authors: Aniz
authors: A
authors: Girach
authors: Stanislao
authors: S
authors: Rizzo
authors: Robert C
authors: RC
authors: Sergott
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002386:Cataract / Q000139:chemically induced; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology*; D005128:Eye Diseases / Q000188:drug therapy*; D005260:Female; D005341:Fibrinolysin / Q000009:adverse effects* / Q000627:therapeutic use; D005343:Fibrinolytic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000009:adverse effects* / Q000627:therapeutic use; D012164:Retinal Diseases / Q000188:drug therapy*; D000267:Tissue Adhesions / Q000188:drug therapy; D014792:Visual Acuity / Q000187:drug effects; D014822:Vitreous Body / Q000187:drug effects*; D055815:Young Adult
chemical_list: D005343:Fibrinolytic Agents; D010446:Peptide Fragments; C054561:microplasmin; D005341:Fibrinolysin