April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Postmarketing Surveillance Survey of Adverse Events of Ocriplasmin (Jetrea®)
Author Affiliations & Notes
  • Sumit P Shah
    NJ Retina, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ
  • Karen Jeng
    NJ Retina, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ
  • Howard F Fine
    NJ Retina, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ
  • Harold M Wheatley
    NJ Retina, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ
  • Daniel B Roth
    NJ Retina, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 2208. doi:
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    • Get Citation

      Sumit P Shah, Karen Jeng, Howard F Fine, Harold M Wheatley, Daniel B Roth; Postmarketing Surveillance Survey of Adverse Events of Ocriplasmin (Jetrea®). Invest. Ophthalmol. Vis. Sci. 2014;55(13):2208.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose
 

To study the postmarketing safety profile of ocriplasmin (Jetrea®) as experienced by retinal physicians in the United States.

 
Methods
 

Two thousand four hundred sixty-five (2465) retinal physicians were surveyed via the web based SurveyMonkey® software regarding their frequency of use of ocriplasmin and incidence of ocular adverse events.

 
Results
 

There were 270 respondents (11.0%) who reported treating 1056 eyes with ocriplasmin; 91.5% of respondents were male and 8.5% were female. Geographic distribution of respondents was: Northeast (32.1%), South (24.4%), Midwest (24.4%), and West coast (19.1%). Practice type distribution included: retina group practice (49.4%), multispecialty group practice (23.2%), full time academic practice (16.2%), solo private practice (10.7%). The incidence of adverse events were as follows: acute decline in visual acuity 179 (16.95%), development of submacular fluid or serous retinal detachment 108 (10.23%), dyschromatopsia 96 (9.09%), progression of VMT to macular hole 92 (8.71%), development of retinal detachment 28 (2.65%), development of retinal tear 21 (1.99%), development of afferent pupillary defect 19 (1.80%), ERG abnormalities 6 (0.57%), crystalline lens instability 4 (0.38%), and vasculitis 3 (0.28%). 15.9% of physicians who experienced an adverse event reported their incident to the Food and Drug Administration and 84.1% did not.

 
Conclusions
 

Although the incidence of many ocular adverse events reported in this study are comparable to those reported in the phase III registration trials, additional phase IV safety studies are warranted to better understand the pathophysiology of ocular adverse events of ocriplasmin.

 
Keywords: 462 clinical (human) or epidemiologic studies: outcomes/complications • 692 retinal adhesion • 503 drug toxicity/drug effects  
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