ThromboGenics Initiates Major Post-Marketing Patient Trial with JETREA® in the US
LEUVEN, Belgium, March 4, 2014 /PRNewswire/ --
Ocriplasmin Research to Better Inform Treatment (ORBIT) study designed to generate further data on the "real world" use of JETREA®
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines for the back of the eye, today announces that it is to shortly initiate a US Phase IV study with JETREA®. The Ocriplasmin Research to Better Inform Treatment (ORBIT) study is designed to generate further data on the real-world use of JETREA®.
The ORBIT study will recruit 1,500 patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) patients across 120 retina centers in the US. The prospective, observational study will assess clinical outcomes and safety of JETREA® administered in a real-world setting for the treatment of symptomatic VMA/VMT by assessing both anatomical and functional outcomes. The study will look at a number of parameters including resolution of VMA, Full Thickness Macular Hole (FTMH) closure, changes in visual acuity (VA) and occurrence and time to vitrectomy. It will also monitor adverse drug reactions (ADRs) and changes from baseline in ocular signs and symptoms across time. These data will further characterize the efficacy and safety profile of the product and provide data complementary to those from the phase III clinical program and its first year on the market.
Patients will be followed for up to 12 months following treatment with JETREA®. The ORBIT study is expected to start recruiting patients this month and is due to complete in mid-2016.
Dr Patrik De Haes, CEO of ThromboGenics, comments: "The start of the ORBIT study in the US reflects ThromboGenics' commitment to gain further knowledge on the real world use of JETREA®. We feel that it is important with such a novel treatment option as JETREA® to conduct a significant post marketing study in order to assess which patients gain the greatest benefit from the first pharmacological option that is designed for the treatment of symptomatic VMA/VMT. The desire for more information on the real-world experience with JETREA® is shared by our partner Novartis/Alcon which is conducting a parallel patient study outside the US."
About JETREA® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin. 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.
In the US and Canada, JETREA® is indicated for the treatment of symptomatic vitreomacular adhesion (VMA). In Europe, JETREA® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter ≤ 400 microns.
JETREA® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the US 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.
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. Under this agreement, ThromboGenics will receive significant royalties from Alcon's net sales of JETREA®. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.
Alcon has launched JETREA® in the UK, Germany, Italy, Finland, Denmark, Norway, Sweden and Canada.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403, for the treatment of ophthalmic and oncology 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 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.
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.
For further information please contact:
Wouter Piepers, Global Head of Corporate Communications
+32-16-75-13-10 / +32-478-33-56-32
Citigate Dewe Rogerson
David Dible/ Sita Shah