Home » Drug Information » FDA Approved Drugs » 2012
Medical Areas: Ophthalmology | Family Medicine | Infections and Infectious Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved October 2012
Treatment Area: symptomatic vitreomacular adhesion
Jetrea (ocriplasmin) is an alpha-2 antiplasmin reducer. It is a truncated form of the natural human protein plasmin, an enzyme that dissolves protein formations that are crucial to blood clot (thrombus) formation.
Jetrea is specifically indicated for the treatment ofsymptomatic vitreomacular adhesion.
Jetrea is supplied as a solution for intravitreal injection. The recommended dose is 0.125 mg (0.1 mL of the diluted solution) administered by intravitreal injection to the affected eye once as a single dose.
The FDA approval of Jetrea was based on two multicenter, randomized, double masked, placebo-controlled, six month studies in 652 subjects with VMA. The subjects were treated with a single injection of Jetrea or placebo. In both of the studies, the proportion of subjects who achieved VMA resolution at Day 28, the primary endpoint, was significantly higher in the ocriplasmin group compared with the placebo group through Month 6. Study 1: 60% in the Jetrea arm versus 15% in the placebo arm (p<0.02). Study 2: 65% versus 10%, respectively (p<0.01). In addition, a statistically significantly higher percentage of the Jetrea treated arm achieved total posterior vitreous detachment (PVD) at Day 28 compared to the placebo treated arm in Study 1 (16% vs. 6%; p=0.014) and in Study 2 (11% vs. 0%; p<0.01).
Adverse events associated with the use of Jetrea may include, but are not limited to, the following:
- vitreous floaters
- conjunctival hemorrhage
- eye pain
- blurred vision
- macular hole
- reduced visual acuity
- visual impairment
- retinal edema
Mechanism of Action
Jetrea (ocriplasmin) is an alpha-2 antiplasmin reducer. It is a truncated form of the natural human protein plasmin. Ocriplasmin has proteolytic activity against protein components of the vitreous body and the vitreoretinal interface, thereby dissolving the protein matrix responsible for the vitreomacular adhesion.
Stalmans P, Delaey C, de Smet MD, van Dijkman E, Pakola S Intravitreal injection of microplasmin for treatment of vitreomacular adhesion: results of a prospective, randomized, sham-controlled phase II trial (the MIVI-IIT trial). Retina 2010 Jul-Aug;30(7):1122-7
Benz MS, Packo KH, Gonzalez V, Pakola S, Bezner D, Haller JA, Schwartz SD A placebo-controlled trial of microplasmin intravitreous injection to facilitate posterior vitreous detachment before vitrectomy. Ophthalmology 2010 Apr;117(4):791-7
de Smet MD, Gandorfer A, Stalmans P, Veckeneer M, Feron E, Pakola S, Kampik A Microplasmin intravitreal administration in patients with vitreomacular traction scheduled for vitrectomy: the MIVI I trial. Ophthalmology 2009 Jul;116(7):1349-55, 1355.e1-2. Epub 2009 May 17
For additional information regarding Jetrea or symptomatic vitreomacular adhesion, please visit the Jetrea web page.