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Retinal Pigment Epithelium Transplantation in a Non-human Primate Model for Degenerative Retinal Diseases
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Post-Marketing Survey of Adverse Events Following Ocriplasmin

Sumit P Shah, Karen W Jeng-Miller, Howard F Fine

    Ophthalmic Surgery, Lasers & Imaging Retina
    |February 16, 2016
    PubMed
    Abstract

    Insights

    Retinal physicians reported adverse events with ocriplasmin (Jetrea), including vision decline and retinal detachment. Further studies are needed to understand these ocular side effects.

    Area of Science:

    • Ophthalmology
    • Retinal Diseases
    • Pharmacovigilance

    Background:

    • Ocriplasmin (Jetrea) is a therapeutic agent used for vitreomacular traction.
    • Post-marketing surveillance is crucial for evaluating drug safety in real-world clinical settings.

    Purpose of the Study:

    • To investigate the post-marketing safety profile of ocriplasmin in the United States.
    • To document ocular adverse events (AEs) experienced by patients treated with ocriplasmin.

    Main Methods:

    • A survey was distributed to 2,465 retinal physicians in the United States.
    • Physicians reported their frequency of ocriplasmin use and observed ocular adverse events.

    Main Results:

    • 270 physicians (11%) reported treating 1,056 eyes with ocriplasmin.
    • Adverse events included acute visual acuity decline (16.95%), submacular fluid/serous retinal detachment (10.23%), and dyschromatopsia (9.09%).
    • Other reported AEs included macular hole progression (8.71%), retinal detachment (2.65%), and retinal tear (1.99%).

    Conclusions:

    • Some reported ocular AEs are comparable to those in phase 3 trials.
    • Additional phase 4 studies are necessary to understand the pathophysiology and clinical significance of ocriplasmin's ocular AEs.

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