title: Post-Marketing Survey of Adverse Events Following Ocriplasmin.
abstract: OBJECTIVE
  To study the post-marketing safety profile of ocriplasmin (Jetrea; ThromboGenics, Iselin, NJ) as experienced by retinal physicians in the United States.
  
  
  METHODS
  Two thousand four hundred sixty-five retinal physicians were surveyed regarding their frequency of use of ocriplasmin and reports of ocular adverse events.
  
  
  RESULTS
  There were 270 respondents (11%) who reported treating 1,056 eyes with ocriplasmin. The reports of adverse events (AE) were as follows: acute decline in visual acuity (16.95%), development of submacular fluid or serous retinal detachment (10.23%), dyschromatopsia (9.09%), progression of vitreomacular traction to macular hole (8.71%), development of retinal detachment (2.65%), development of retinal tear (1.99%), development of afferent pupillary defect (1.80%), electroretinography abnormalities (0.57%), crystalline lens instability (0.38%), and vasculitis (0.28%).
  
  
  CONCLUSIONS
  Although the frequency of some ocular AEs reported in this study are comparable to those reported in the phase 3 registration trials, additional phase 4 safety studies are warranted to better understand the pathophysiology and clinical relevance of ocular AEs of ocriplasmin.
authors.forename: Sumit P
authors.initials: SP
authors.lastname: Shah
authors.forename: Karen W
authors.initials: KW
authors.lastname: Jeng-Miller
authors.forename: Howard F
authors.initials: HF
authors.lastname: Fine
authors.forename: H Matthew
authors.initials: HM
authors.lastname: Wheatley
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Roth
authors.forename: Jonathan L
authors.initials: JL
authors.lastname: Prenner
mesh_terms: D004363:Drug Utilization / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005341:Fibrinolysin / Q000009:adverse effects*; D005343:Fibrinolytic Agents / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D009885:Ophthalmology / Q000706:statistics & numerical data; D010446:Peptide Fragments / Q000009:adverse effects*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D014792:Visual Acuity / Q000502:physiology
chemical_list: D005343:Fibrinolytic Agents; D010446:Peptide Fragments; C054561:microplasmin; D005341:Fibrinolysin