NEW ORLEANS — A post-marketing safety evaluation thus far has been consistent with the pre-marketing clinical trial program for ocriplasmin, according to a speaker here.
“At the most recent retina meeting, it became clear that there was significant concern among colleagues regarding post-marketing events surrounding ocriplasmin [Jetrea, ThromboGenics],” Paul Hahn, MD, PhD, said at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting. In response to that concern, the American Society of Retina Specialists convened a Therapeutic Surveillance Committee to compile post-marketing data.
ThromboGenics provided raw, unfiltered data that were independently and objectively analyzed by the committee, Hahn said.
Pre-marketing data are based on 999 total injections, with 465 that went on to phase 3 trials; post-marketing data are based on 4,387 injections as of July.
“Post-market analysis is critical to understand 'real-world' drug- and device-related experiences. As a novel first-in-class therapy, ocriplasmin has introduced a unique side effect profile, which we have not previously seen,” Hahn said. “For all newly marketed therapies, known complications should be put into context, and patient expectations should be managed accordingly.”
Disclosure: Hahn has no relevant financial disclosures.