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Speaker: Rates of adverse events comparable for ocriplasmin in clinical trials, postmarket data
MIAMI — Despite "vastly different methodology" in data capture between the clinical trial program for ocriplasmin as a treatment for symptomatic vitreomacular adhesion and the postmarketing analyses, which may be "woefully underreported," comparable frequencies of adverse events are seen between the two, Baruch D. Kuppermann, MD, said here.
"We're trying to get a handle on adverse events. It's a new product. There are adverse events that are occurring. It is important for us to understand them so we can set both physician and patient expectations," Kuppermann said at the Angiogenesis, Exudation, and Degeneration 2014 meeting.
Baruch D. Kuppermann
According to the presentation, rates of occurrence in the clinical trial program vs. postmarket experience are as follows for some of the adverse events of interest: acute reduction in visual acuity, 7.7% vs. 1.3%; significant reduction in visual acuity, 0.9% vs. 0.5%; dyschromatopsia, 1.6% vs. 0.5%; new or worsening macular hole, 6.7% vs. 0.1%; and inner segment/outer segment (ellipsoid zone) changes, not measured vs. 0.2%.
"Postmarketing safety data is always suspect," Kuppermann said, referring to the issue of underreporting. "In this case, we have reason to believe that [the data are] better than usual. The fact that we are a small community with a small number of injections, and the concern that we have is significant enough to report to the company, it seems to correlate very well with the clinical trial data set."
Disclosure: Kuppermann is a consultant for Alcon and does clinical research for Alcon and ThromboGenics.