Advocacy & Practice Updates — Advocacy & Practice
FDA Alert: FDA Issues Safety Labeling Change for Jetrea
The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a safety labeling change for Jetrea (ocriplasmin intravitreal injection, 2.5 mg/mL, ThromboGenics, Inc, Iselin, NJ). In the "Use in Specific Populations" section, the FDA has added, "The use of Jetrea in pediatric patients is not recommended."
According to the FDA, researchers conducted "a single-center, randomized, placebo-controlled, double-masked clinical study to investigate the safety and efficacy of a single intravitreal injection of 0.175 mg ocriplasmin in pediatric subjects as an adjunct to vitrectomy." The study involved 24 eyes of 22 patients, and found "no statistical or clinical differences between groups for the induction of total macular PVD, any of the secondary endpoints, or adverse events."
Updated July 15, 2014