LEUVEN, Belgium, March 2, 2015 (GLOBE NEWSWIRE) -- ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a new ready-diluted formulation of JETREA® (ocriplasmin). JETREA® is approved in the EU for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. VMT is an age-related progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness.
The introduction of the new formulation of JETREA® will eliminate the preparatory dilution steps prior to injection.
At the point of administration into the eye, the strength, potency, composition and pharmaceutical form of the ready-diluted formulation remain identical to the currently available formulation after dilution.
Dr. Patrik De Haes, CEO of ThromboGenics, said, "We are very pleased that the CHMP has provided a positive recommendation for our new ready-diluted formulation of JETREA®. With this new formulation, it will be easier and more convenient for retina physicians to use this novel pharmacological option for the treatment of patients with VMT. We anticipate a final approval decision from the European Commission within the next 2 to 3 months paving the way for the eventual introduction of this new formulation across all 28 European Union Member States plus Iceland and Norway."
ThromboGenics' partner Alcon, who is commercializing JETREA® outside the US, will be responsible for planning the launch of the new ready-diluted formulation.
For further information please contact:
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ThromboGenics Wouter Piepers, Global Head of Corporate Communications & IR +32 16 75 13 10 / +32 478 33 56 32 wouter.piepers@thrombogenics.com |
Citigate Dewe Rogerson David Dible/Malcolm Robertson Tel: +44 20 7282 2867 Malcolm.robertson@citigatedr.co.uk |
About ThromboGenics
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic and oncology medicines. The Company's lead product, JETREA® (ocriplasmin), has been approved by the US FDA for the treatment of symptomatic VMA and was launched in January 2013.
ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of JETREA® outside the United States.
ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com.
About JETREA® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin. In the US, JETREA® is indicated for the treatment of symptomatic VMA. In Europe, JETREA® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. 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.
JETREA® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
JETREA's Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA was generally well tolerated with most adverse events being transient and mild in severity.
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. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction.
No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.
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