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FDA Okays Jetrea (Ocriplasmin) for Symptomatic Vitreomacular Adhesion
The FDA has approved Jetrea (ocriplasmin, ThromboGenics) for the treatment of symptomatic vitreomacular adhesion (VMA), a progressive sight-threatening condition.
Jetrea is the first pharmacological agent to be approved for this indication.
The drug’s 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 injection. Jetrea is provided as a single-use glass vial containing 0.5 mg in 0.2 mL of solution for intravitreal injection (2.5 mg/mL).
The FDA approval was based on data from a phase III program in which Jetrea was shown to be superior to placebo for the treatment of symptomatic VMA (26.5% versus 10.1%, respectively; P
Symptomatic VMA is a progressive condition that, if left untreated, often leads to retinal distortion and further deterioration in vision that can ultimately result in irreversible damage. Market surveys suggest that approximately 500,000 patients in the U.S. and Europe may benefit from treatment with Jetrea each year.
The U.S. launch is scheduled for January 2013.
Source: ThromboGenics, October 18, 2012.