SAFETY PROFILE OF OCRIPLASMIN FOR SYMPTOMATIC VITREOMACULAR ADHESION: A Comprehensive Analysis of Premarketing and Postmarketing Experiences. Retina 2015 Jun;35(6):1128-34
Date
01/31/2015Pubmed ID
25635575DOI
10.1097/IAE.0000000000000519Scopus ID
2-s2.0-84930480357 (requires institutional sign-in at Scopus site) 53 CitationsAbstract
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.
Author List
Hahn P, Chung MM, Flynn HW Jr, Huang SS, Kim JE, Mahmoud TH, Sadda SR, Dugel PUMESH terms used to index this publication - Major topics in bold
Clinical Trials as TopicColor Vision Defects
Drug Evaluation, Preclinical
Drug-Related Side Effects and Adverse Reactions
Electroretinography
Eye Diseases
Fibrinolysin
Fibrinolytic Agents
Humans
Intravitreal Injections
Lens Subluxation
Peptide Fragments
Photoreceptor Cells, Vertebrate
Product Surveillance, Postmarketing
Reflex, Pupillary
Retinal Detachment
Retinal Diseases
Retinal Perforations
Retrospective Studies
Tissue Adhesions
Visual Acuity
Vitreous Body
