20,000 patients have been treated with JETREA® globally since its launch
LEUVEN, Belgium, Nov. 13, 2015 (GLOBE NEWSWIRE) -- ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that there will be a number of presentations on JETREA®, including further preliminary analysis of the OASIS data at the upcoming American Academy of Ophthalmology (AAO) 2015 meeting, which is taking place in Las Vegas from 14-17 November. The AAO meeting is the largest ophthalmology meeting in the world with more than 24,000 people expected to attend.
The previously announced top-line results from the OASIS study, in patients being treated for symptomatic vitreomacular adhesion (sVMA), 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-up period was consistent with the drug's overall safety profile as known from the approved label. The 24-month follow-up data is the longest period patients with this condition have been studied post-treatment with this novel medicine. Since launch, over 20,000 patients globally with symptomatic VMA/VMT have been treated with JETREA®.
Dr Patrik De Haes, the CEO of ThromboGenics, comments: "This year's AAO meeting is a milestone event for the ThromboGenics team and the US retina community it serves. We will see the full data analysis of the OASIS study, which showed an excellent top-line outcome in terms of VMA resolution, despite over 20% of patients having ERM at baseline. The positive efficacy results, alongside the product's confirmed safety profile, clearly demonstrate that with improved patient selection, a single injection of JETREA® is a very compelling treatment option for an important group of patients with symptomatic VMA.
"The FDA's recent acceptance of our Investigational New Drug (IND) Application is a key step in allowing us to develop JETREA® for an important new indication. We intend to use our presence at AAO to start to brief retina physicians on our planned CIRCLE study in patients with diabetic retinopathy. This Phase II study, which is due to start around the end of 2015, will assess the ability of multiple doses of JETREA® to treat patients with moderately to very severe Non-Proliferative Diabetic Retinopathy (NPDR) to reduce their risk of progression to Proliferative Diabetic Retinopathy (PDR)".
For further information about the AAO meeting please visit www.aao.org/annual-meeting
For searching ocriplasmin in the program, please consult https://secure.aao.org/apps/
For further information please contact:
| ThromboGenics |
Wouter Piepers, Global Head of Corporate Communications & IR
+32 16 75 13 10 / +32 478 33 56 32
| Citigate Dewe Rogerson |
David Dible/Sylvie Berrebi
Tel: +44 20 7282 2867
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. To-date over 20.000 patients with symptomatic VMA/VMT globally have been treated with JETREA®.
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 SD-OCT to select patients with focal VMA and without Epiretinal Membrane (ERM), two criteria which have been shown to lead to better treatment outcomes with JETREA®. Despite this, OASIS data showed over 20% of the patients recruited into study had ERM.
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.
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative treatments for diabetic eye disease.
The Company's first product, JETREA® (ocriplasmin), has been approved in 53 countries across the globe. In the US, ThromboGenics is commercializing JETREA® via its subsidiary ThromboGenics Inc. ThromboGenics signed an agreement with Alcon, a division of Novartis, for the commercialization of JETREA® outside the United States.
ThromboGenics is planning a Phase II clinical trial with JETREA® in diabetic retinopathy. In addition to JETREA®, the Company is evaluating drug candidates that could potentially deliver a number of next generation treatments for eye disease.
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.
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