- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Okays Jetrea (Ocriplasmin) for Symptomatic Vitreomacular Adhesion
First drug approved for sight-threatening condition (Oct. 18)
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 < 0.01). Treatment with Jetrea was associated with transient ocular adverse events.
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.