ThromboGenics Starts Evaluating JETREA(r) for the Treatment of Retinal Vein Occlusion (RVO)

LEUVEN, Belgium, April 23, 2015 (GLOBE NEWSWIRE) -- Company receives € 0.6 million research grant from IWT, the Flemish Agency for Innovation by Science and Technology

ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative medicines for the treatment of vitreo-retinal diseases, today announces that it is evaluating JETREA^® (ocriplasmin) as a potential treatment for Retinal Vein Occlusion (RVO).

RVO is the third indication ThromboGenics has underway for JETREA^®.

The new research will build on earlier ThromboGenics Phase IIa data pointing out the potential of ocriplasmin (formerly known as microplasmin) for the treatment of peripheral arterial occlusions. With this new vitreo-retinal project, ThromboGenics will demonstrate the potential of using locally delivered ocriplasmin for lysing the blood clots (in the retinal veins) that are responsible for this sight threatening condition.

In support of this research, ThromboGenics has secured a €0.6 million grant from the Flemish Agency for Innovation by Science and Technology (IWT). The Company will use this grant to evaluate ocriplasmin's ability to lyse the clots that cause RVO by local intravenous administration of this thrombolytic agent in pre-clinical models of the disease. For that, the Company will collaborate with the Ophthalmology Department of the University Hospital UZLeuven in Belgium.

The grant will also support a partnership of ThromboGenics with the Mechanical Engineering Department of the KU Leuven. The Department is developing a robotic-assisted system which has the capacity to deliver local administration of ocriplasmin in the retinal veins.

At present, there is no treatment option for clearing retinal veins of RVO-patients. The current standard of care for RVO primarily focuses on the treatment of visual impairment due to macular edema resulting from an existing retinal vein occlusion (central or branch retinal vein occlusion). Although the current treatment paradigm improves the vision of the patient, it comes with a relatively high cost associated with continued drug administrations and follow up by the physician.

"Retinal Vein Occlusion (RVO) is known to be the second most common retinal vascular disease, and thought to negatively impact the quality of life of 16 million patients worldwide, says Prof Dr Peter Stalmans of the Department of Ophthalmology of UZLeuven. RVO, caused by the formation of clots in either the central retinal vein or in branch retinal veins, profoundly affects visual acuity. I'm looking forward to work with ThromboGenics and the robotics experts from the Mechanical Engineering Department of KU Leuven, for the evaluation of ocriplasmin as a potential new treatment of RVO," he concludes.

Dr Patrik De Haes, CEO of ThromboGenics, said, "We are very happy to announce the start of the development of JETREA^® for this third indication. We believe that, when delivered locally, the proven clot busting capabilities of JETREA^® really hold the potential for our drug to become an effective treatment for the many patients globally who suffer from RVO." 

ThromboGenics is a partner of the Leuven Retina Meeting 2015, in Leuven, from 23 to 25 April, 2015. More information at www.LeuvenRetinaMeeting.eu

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About JETREA ^® (ocriplasmin)

JETREA^® (ocriplasmin) is a truncated form of human plasmin. JETREA^® acts as 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.

In the US, JETREA^® is indicated for the treatment of symptomatic vitreomacular adhesion. 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^® was 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. This 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.

In March 2015, ThromboGenics reported top line results from OASIS, a Phase IIIb study. This randomized, sham controlled, double masked study followed-up patients for 24 months post injection. In this study, retina physicians were able to use us SD-OCT to select patients with focal VMA and patients without Epiretinal Membrane (ERM), two criteria which have been shown to lead to better treatment outcomes with JETREA®. OASIS data have shown to include still over 20% ERM patients.

The trial showed that 41.7% of patients treated with JETREA® achieved VMA resolution at Day 28 post injection compared with only 6.2% of patients who received a sham injection (p<0.001); and that the drug's safety profile in the 24 month follow period was consistent with the drug's overall safety profile as known from the approved label.

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) was approved by the US FDA for the treatment of symptomatic VMA and was launched by ThromboGenics in January 2013. 

ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of JETREA^® outside the United States in 2012. To-date JETREA^® has been approved in over 50 countries globally.

JETREA^® is currently being evaluated for two further indications, diabetic retinopathy (DR) and retinal vein occlusion (RVO).

ThromboGenics is the major shareholder in Oncurious NV, a cancer focused company that was formed in conjunction with VIB, a leading life science institute in Flanders (Belgium). Oncurious was created to develop TB-403, initially for medulloblastoma, the most frequent form of pediatric brain cancer. ThromboGenics has retained the exclusive rights to use TB-403 for ophthalmic indications.

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.

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