Safety profile of ocriplasmin for symptomatic vitreomacular adhesion: A comprehensive analysis of premarketing and postmarketing experiences

Paul Hahn, Mina M. Chung, Harry W Flynn, Suber S. Huang, Judy E. Kim, Tamer H. Mahmoud, Srinivas R. Sadda, Pravin U. Dugel

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Purpose: After the recent approval of ocriplasmin by the Food and Drug Administration, postmarketing safety concerns have been raised by the vitreoretinal community. The American Society of Retina Specialists Therapeutic Surveillance Committee was commissioned to monitor postmarketing drug-related and device-related adverse events. The purpose of this report is to analyze the postmarketing safety experience in the context of available premarketing safety data. Methods: Periodic aggregate safety reports consisting of premarketing, or clinical trial, data (n 999 injections) and postmarketing reports through July 16, 2013 (n 4,387 injections), were retrospectively analyzed by the TSC. The aggregate data were analyzed to classify adverse events, and the postmarketing safety data for each event type were compared with the premarketing data. Results: Eight categories of adverse events were identified. Acute reduction in visual acuity attributable to either worsening of macular pathology or development of subretinal fluid, electroretinogram changes, dyschromatopsia, retinal tears and detachments, lens subluxation or phacodonesis, impaired pupillary reflex, and retinal vessel findings were reported in both the premarketing and postmarketing experiences. Ellipsoid zone (inner segment/outer segment) findings were only reported in the postmarketing experience. Rates of postmarketing reports were lower than in the premarketing data. Adverse events were generally transient, and characteristics of these adverse events were generally similar between the premarketing and postmarketing experience. Conclusion: Postmarket analyses are limited by significant underreporting, and in the case of ocriplasmin as a first in-class drug, they may not have captured safety events that have only more recently been identified. Nonetheless, postmarket analyses can identify the scope of potential safety events based on real-world experiences. Ocriplasmin administration should be guided by an appropriate and informed risk-benefit discussion with the patient. Ongoing active postmarket surveillance by all practitioners will continue to be critical to better understand this safety profile.

Original languageEnglish (US)
Pages (from-to)1128-1134
Number of pages7
JournalRetina
Volume35
Issue number6
DOIs
StatePublished - Jun 6 2015

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Safety
Pupillary Reflex
Lens Subluxation
Pharmacy and Therapeutics Committee
Subretinal Fluid
Retinal Vessels
Retinal Perforations
Injections
microplasmin
Retinal Detachment
United States Food and Drug Administration
Pharmaceutical Preparations
Visual Acuity
Retina
Clinical Trials
Pathology
Equipment and Supplies

Keywords

  • adverse events
  • ocriplasmin
  • postmarketing
  • premarketing
  • safety
  • vitreomacular adhesion

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Safety profile of ocriplasmin for symptomatic vitreomacular adhesion : A comprehensive analysis of premarketing and postmarketing experiences. / Hahn, Paul; Chung, Mina M.; Flynn, Harry W; Huang, Suber S.; Kim, Judy E.; Mahmoud, Tamer H.; Sadda, Srinivas R.; Dugel, Pravin U.

In: Retina, Vol. 35, No. 6, 06.06.2015, p. 1128-1134.

Research output: Contribution to journalArticle

Hahn, Paul ; Chung, Mina M. ; Flynn, Harry W ; Huang, Suber S. ; Kim, Judy E. ; Mahmoud, Tamer H. ; Sadda, Srinivas R. ; Dugel, Pravin U. / Safety profile of ocriplasmin for symptomatic vitreomacular adhesion : A comprehensive analysis of premarketing and postmarketing experiences. In: Retina. 2015 ; Vol. 35, No. 6. pp. 1128-1134.
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