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Contact: Oxurion
General Information
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 of symptomatic 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.
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.
Side Effects
Adverse events associated with the use of Jetrea may include, but are not limited to, the following:
- vitreous floaters
- conjunctival hemorrhage
- eye pain
- photopsia
- blurred vision
- macular hole
- reduced visual acuity
- visual impairment
- retinal edema
Clinical Trial Results
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).
Approval Date: 2012-10-01
Company Name: Oxurion