Belgium's ThromboGenics is trying to make its likely New Year's wish a reality: A 2012 commercial launch of ocriplasmin to treat symptomatic vitreomacular adhesion by way of an injection into the eyeball.
The company announced in late December that it had filed a biologics license application with the FDA for the indication. ThromboGenics submitted a similar application in October with European regulators. And so CEO Patrik De Haes emphasized in a year-end statement that the company is building its commercial capabilities with anticipation of that launch, and also reaching out to hundreds of retinal specialists in the U.S. and overseas.
For the FDA submission, ThromboGenics backed its application with two Phase III studies involving 652 patients in the U.S. and Europe. The company believes that the drug has significant market potential with as many as 500,000 patients in the U.S. and major European markets eligible for treatment once it launches commercially.
Symptomatic VMA can permanently damage vision if left untreated. ThromboGenics notes that its drug, if approved, would be the first of its kind for the condition. Right now, surgery is the only option, and only when the degeneration reaches a certain point. An approved drug would represent a success story for delivering treatments to the eye. It is often a struggle to develop sufficient levels of a drug that can penetrate the eye and reach its target.
- here's the release
- check out the Pharmaceutical Business Review story
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