The FDA has approved Jetrea (ocriplasmin; ThromboGenics) for the treatment of symptomatic vitreomacular adhesion (VMA), a progressive sight threatening condition. Jetrea is the first phamacological agent to be approved for this indication. Symptomatic VMA is a progressive condition that if left untreated frequently leads to retinal distortion, further deterioration in vision and has the potential to cause irreversible damage and complications.
The approval was based on data from ThromboGenics’ Phase 3 program where Jetrea was shown to be superior to placebo for the treatment of symptomatic VMA (26.5% versus 10.1%; p<0.01).
Jetrea is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion. It will be supplied as a single-use glass vial containing 0.5mg in 0.2mL solution for intravitreal injection (2.5mg/mL). The product will be available January 2013.
For more information visit www,jetrea,com or call (855) 538-7321.