ThromboGenics to begin Jetrea study in USA

Belgium-based biopharma firm ThromboGenics (Euronext Brussels: THR) will soon initiate a US Phase IV study with Jetrea (ocriplasmin). 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 USA. 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.

More real world data needed