You are here

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

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.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks