LEUVEN, Belgium, April 29, 2014 (GLOBE NEWSWIRE) -- ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines for the back of the eye, todayannounces that the 50th retina center has been activated to evaluate patients in the US ORBIT Phase IV study with JETREA®. ORBIT (Ocriplasmin Research to Better Inform Treatment) is an observational study designed to generate further data on the real-world use of JETREA® in the US. Patient enrollment is open and underway at all activated sites.
ORBIT will recruit 1,500 patients with symptomatic vitreomacular adhesion (VMA) 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 15 months on the market. .
Patients will be followed for up to 12 months following treatment with JETREA®. The ORBIT study is due to complete in mid-2016. Data will be presented on a regular basis. First data may be expected as early as by the end of 2014.
"I congratulate ThromboGenics on gathering real world data on the use of JETREA® for the treatment of symptomatic vitreomacular adhesion. By analyzing this large cohort we will be able to better determine which patients most benefit from this treatment and to also see the results of surgical intervention if needed. With this observational study, incidence of adverse events and true success rate can be further characterized," said David Boyer, MD- Retina-Vitreous Associates Medical Group, Beverly Hills, CA.
Dr Patrik De Haes, CEO of ThromboGenics, comments: "We are pleased to see this high level of interest from the US retina community to take part in the ORBIT study. With 50 centers already in a position to recruit patients, we are optimistic that we can complete this study by mid-2016, with first data potentially available by end of 2014. ThromboGenics' decision to undertake the ORBIT study underwrites our commitment to help the community gain further knowledge about the real world use of JETREA® and in particular to understand which patients gain the greatest benefit from the first pharmacological option for the treatment of symptomatic VMA/VMT. "
full press release http://hugin.info/137324/R/1780792/608976.pdf