ThromboGenics Submits Biologics License Application for Ocriplasmin to the U.S. FDA
LEUVEN, Belgium, December 23, 2011 /PRNewswire/ --
If approved, ocriplasmin will be the first pharmacological treatment for symptomatic vitreomacular adhesion (VMA) including macular hole
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that it has submitted a Biologics License Application (BLA) with the U.S. 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 U.S. 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 U.S. suffering from a sight-threatening disorder. A standard review by the FDA will allow us to manage our U.S. 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 U.S. 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 ophthalmology."
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 U.S. who could potentially benefit from ocriplasmin.
ThromboGenics is a biopharmaceutical company focused on developing innovative ophthalmic medicines. The Company's lead product ocriplasmin has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic vitreomacular adhesion (VMA). The MAA for ocriplasmin has been accepted for review in Europe and the BLA has been filed in the U.S. Ocriplasmin is in Phase II clinical development for additional vitreoretinal conditions.
ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International. These include TB-402 (anti-Factor VIII), a long-acting anticoagulant in Phase II, and TB-403 (anti-PlGF) in Phase Ib/II for cancer in partnership with Roche.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at http://www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
For further information please contact:
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Citigate Dewe Rogerson
David Dible / Nina Enegren / Sita Shah