Safety profile of ocriplasmin for symptomatic vitreomacular adhesion - a comprehensive analysis of pre- and post-marketing experiences

Abstract

Purpose: Following the recent approval of ocriplasmin by the Food and Drug Administration, post-marketing safety concerns have been raised by the vitreoretinal community. The American Society of Retina Specialists (ASRS) Therapeutic Surveillance Committee (TSC) was commissioned to monitor post-marketing drug- and device-related adverse events. The purpose of this report is to analyze the post-marketing safety experience in the context of available pre-marketing, clinical trial safety data.

Methods: Periodic aggregate safety reports consisting of pre-marketing, or clinical trial, data (n=999 injections) and post-marketing reports (n=4,387 injections) were analyzed by the TSC. The aggregate data were analyzed to classify adverse events, and post-marketing safety data for each event type were compared to the pre-marketing data.

Results: Eight categories of adverse events were identified. Acute reduction in visual acuity, electroretinogram changes, dyschromatopsia, retinal tears and detachments, lens subluxation or phacodonesis, impaired pupillary reflex, and retinal vessel findings were reported in both the pre- and post-marketing experiences. Ellipsoid zone (inner segment/outer segment) findings were only reported in the post-marketing experience. Rates of post-marketing reports were lower than in the pre-marketing data. Adverse events were generally transient, and characteristics of these adverse events were generally similar between the pre- and post-marketing experience.

Conclusions: Based on this report, it is the opinion of the TSC that the post-marketing safety profile following ocriplasmin administration has thus far been consistent with the pre-marketing clinical trial program. Post-market analysis can uncover unidentified adverse events and places known events in context but is limited by the nature of voluntary reporting. The TSC urges informed management of patient expectations and active post-market surveillance by all practitioners.

Keywords: 763 vitreous • 462 clinical (human) or epidemiologic studies: outcomes/complications • 503 drug toxicity/drug effects