On-going ORBIT and OZONE real-world data studies with JETREA® progressing as planned
Leuven, October 14, 2014 - ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that it will be undertaking a wide ranging program of activities to highlight the benefits of JETREA® (ocriplasmin) at the upcoming American Association of Ophthalmology (AAO) 2014 meeting, which is taking place in Chicago from 17-21 October. The AAO meeting is the largest ophthalmology meeting in the world with more than 24,000 people expected to attend.
ThromboGenics' activities at AAO will focus on continued medical education to help the retina community further characterize both the efficacy and safety profile of its lead drug JETREA®. The Company will host a number of expert presentations at its booth during AAO, outlining personal experiences in using this novel medicine, the first and only pharmacologic intervention approved for the treatment of symptomatic vitreomacular adhesion (VMA).
Medical affairs staff will be available to meet the retina physicians taking part, or interested in the on-going ORBIT and OZONE studies which have been designed to provide further real-world data on JETREA®. These studies are intended to help the retina community to further characterize JETREA®'s efficacy and safety profile, allowing specialists to build the proper level of confidence while treating patients suffering from symptomatic VMA. Symptomatic VMA is a progressive sight-threatening disease, which if left untreated, might lead to a macular hole and central blindness.
Paul G. Howes, Executive Chairman of ThromboGenics Inc., said: "We plan a broad range of medical education activities at this major conference which are designed to help drive the adoption of this novel medicine. We are looking forward to further dialogue with the many retinal physicians who are taking part in the on-going ORBIT and OZONE studies as we work to generate the additional real-world data needed to ensure that JETREA® is used optimally for the benefit of the many people in the US suffering from symptomatic VMA."
Dr Patrik De Haes, the CEO of ThromboGenics, said: "This year's AAO meeting is another key moment for ThromboGenics as we continue to underwrite our strong commitment and continued support to the US retina community."
Ends
For further information please contact:
| ThromboGenics Wouter Piepers, Global Head of Corporate Communications & Investor Relations +32 16 75 13 10 / +32 478 33 56 32 wouter.piepers@thrombogenics.com | Citigate Dewe Rogerson David Dible/ Sita Shah Tel: +44 20 7638 9571 sita.shah@citigatedr.co.uk |
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.
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.
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.