Ocriplasmin outcomes favorable in post-marketing experience

October 20, 2014

Data reported by American surgeons using ocriplasmin for treatment of symptomatic vitreomacular adhesion (VMA) show that it is possible to increase the success rate through careful patient selection, said David Chow, MD.

Chicago-Data reported by American surgeons using ocriplasmin for treatment of symptomatic vitreomacular adhesion (VMA) show that it is possible to increase the success rate through careful patient selection, said David Chow, MD.

However, practice pattern data show that use of ocriplasmin (Jetrea, ThromboGenics) by American surgeons still lags behind surgery as the preferred method for managing VMA/vitreomacular traction, even in ideal patients.

In the ocriplasmin pivotal trials, resolution of VMA at day 28 post-injection was achieved in 26.5% of ocriplasmin-treated eyes compared with 10% of vehicle-treated controls. Subsequent analyses led to the identification of predictors of response, and outcomes from U.S. centers using this information as criteria for patient selection show a near doubling of the success rate compared with that achieved in the pivotal trial.

“With the data pooled, these reports include 359 eyes and show a success rate of 50%,” said Dr. Chow, assistant professor of ophthalmology and vision sciences, University of Toronto, Ontario.

“In Canada, ocriplasmin has only been available for 9 months, and so far, more than 200 treatments have been done,” he said. “We are reviewing the outcomes for a later presentation, but anecdotally, the results are very good as well with adherence to the ideal patient criteria for case selection.”

 

Information on utilization of ocriplasmin in the U.S. comes from findings of the 2014 American Society of Retina Specialists Practice and Trends Survey.

When asked: “How do you manage a patient with a stage 2 macular hole with concurrent traction?”, 75% of surgeons said they would choose surgery and only 14.5% said ocriplasmin. When asked: “How is a patient with a symptomatic focal vitreomacular traction and visual acuity of 20/60 best managed?”, 26% of US surgeons said ocriplasmin, while 62% chose surgery.

Dr. Chow also noted that the side effect profile of ocriplasmin in post-market approval use has been acceptable. In an analysis of more than 10,000 treated eyes, various adverse events of special interest occurred at lower rates than in the pivotal trials.

He said that some concerns about safety that emerged in the pivotal trials are now being more thoroughly studied in ongoing trials, including a phase IV registry-based study that is gathering data on real world experience and the side effect profile of ocriplasmin.