Post-Marketing Survey of Adverse Events Following Ocriplasmin.
Ophthalmic Surg Lasers Imaging Retina
; 47(2): 156-60, 2016 Feb.
Article
em En
| MEDLINE
| ID: mdl-26878449
ABSTRACT
BACKGROUND AND OBJECTIVE:
To study the post-marketing safety profile of ocriplasmin (Jetrea; ThromboGenics, Iselin, NJ) as experienced by retinal physicians in the United States. STUDY DESIGN/MATERIALS ANDMETHODS:
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%).CONCLUSION:
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Fragmentos de Peptídeos
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Vigilância de Produtos Comercializados
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Fibrinolisina
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
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Fibrinolíticos
Tipo de estudo:
Incidence_studies
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Prognostic_studies
Limite:
Female
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Humans
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Male
Idioma:
En
Revista:
Ophthalmic Surg Lasers Imaging Retina
Ano de publicação:
2016
Tipo de documento:
Article