BETHESDA, MD 18 October 2012—Belgium-based ThromboGenics NV today announced that FDA approved the marketing of ocriplasmin, or Jetrea, for the treatment of symptomatic vitreomacular adhesion, a condition that can eventually damage patients' eyesight.
The recombinant enzyme breaks down the protein structure of the gel-like vitreous body, imitating the normal aging process, the company said. In instances when this aging process does not occur, the vitreous body does not completely separate from the macula, which adversely affects patients' vision.
Until the approval of ocriplasmin, according to ThromboGenics, surgical removal of the vitreous body has been the only treatment for symptomatic vitreomacular adhesion.
The labeling (PDF) for ocriplasmin states that a single injection of the drug into the vitreous cavity resolved the adhesion in about one fourth of patients.
Jetrea will be available as a solution that must be diluted with preservative-free 0.9% sodium chloride injection immediately before use. Although the properly diluted solution contains 0.5 mg of drug in 0.4 mL and the recommended dose is 0.125 mg, or 0.1 mL, the labeling explicitly states that the solution is for single use only.
According to the product's labeling, the most commonly reported adverse reactions to ocriplasmin during the clinical trials were vitreous floaters, conjunctival hemorrhage, eye pain, photophobia, and blurred vision.
The company said those adverse reactions were mainly transient.
Jetrea vials must be stored frozen at or below –20 °C until shortly before use. The labeling recommends keeping the vials in their original package to protect the drug from light.
ThromboGenics said it plans to launch the product in January 2013.