ThromboGenics NV, a Leuven, Belgium-based biopharmaceutical company focused on developing innovative ophthalmic medicines, has submitted a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for ocriplasmin Intravitreal injection, 2.5 mg/mL, for the treatment of symptomatic VMA including macular hole.
The BLA submission, which includes data from two pivotal phase III trials involving 652 patients in the US and Europe, will undergo a standard review by the FDA. In October 2011, the European Medicines Agency accepted for review ThromboGenics’ Marketing Authorisation Application (MAA) for ocriplasmin for the same indication.
Dr Patrik De Haes, ThromboGenics’ CEO, said: “Today’s submission is a key step towards making ocriplasmin available to the many thousands of patients in the US suffering from a sight-threatening disorder. A standard review by the FDA will allow us to manage our US and European submissions in parallel. In anticipation of these approvals, we are continuing to invest in our commercial organization as we work to build advocacy with the US and international retinal specialist community. With the regulatory dossiers for ocriplasmin now filed, I believe we are making excellent progress towards our goal of becoming a leading biopharmaceutical company focused on addressing unmet needs in ophthalmoloy.”
Symptomatic VMA including macular hole is a progressive condition that if left untreated generally leads to significant visual distortion, deterioration in vision, and in some cases central blindness. Market research conducted by ThromboGenics suggests that there are approximately 500,000 patients annually in the major markets of the EU and the US who could potentially benefit from ocriplasmin.