ThromboGenics has taken steps to expand its research of treatments for vitreomacular adhesion (VMA) and diabetic macular edema (DME).
The company announced that is will soon initiate a U.S.-phase IV study with ocriplasmin (Jetrea). The Ocriplasmin Research to Better Inform Treatment (ORBIT) study is designed to generate further data on the real-world use of the drug.
“The start of the ORBIT study in the United States reflects ThromboGenics’ commitment to gain further knowledge on the real-world use of (the drug),” said Patrik De Haes, MD, chief executive officer of ThromboGenics. “We feel that it is important with such a novel treatment option as (ocriplasmin) to conduct a significant post-marketing study in order to assess which patients gain the greatest benefit from (it).”
The study will recruit 1,500 patients with symptomatic VMA/vitreomacular traction (VMT) patients across 120 retina centers in the United States.
The prospective, observational study will assess clinical outcomes and safety of the drug administered in a real-world setting for the treatment of VMA/VMT by examining both anatomical and functional outcomes. The study will look at a number of parameters including resolution of VMA, full-thickness macular hole closure, changes in visual acuity, and occurrence and time to vitrectomy.
It will also monitor adverse drug reactions 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 the drug.
The study is expected to start recruiting patients this month, and is due to complete in mid-2016.
Additionally, the company has been awarded a €3 million grant from the Flemish agency for Innovation by Science and Technology (IWT).
The grant funding will be used by the company to support research into potential new biotherapeutics for the treatment of DME. The aim of these new therapeutics will be to reduce the vascular leakage and inflammation which are central to the sight-threatening condition.
“The award of this grant from IWT will enable us to continue to progress our research activities in the field of diabetic eye diseases,” Dr. De Haes said. “DME is a very prevalent condition where there is still scope to improve on the clinical outcomes delivered by current treatment options.”
The company intends to use the funding to develop a better understanding of the role of a novel pathway in DME as the basis for discovering new pre-clinical therapeutic candidates. This pathway is thought to play an important role in the development of DME by modulating vascular leakage and inflammation.
A key part of the IWT grant-funded work will be the development of new in vitro assays and in vivo models to identify biotherapeutics which activate the pathway. This will allow the company to identify pre-clinical candidates that meet a target product profile based around in vitro potency, in vivo efficacy, and drug-like properties.
These new candidates will be generated by the company leveraging the AMP-Rx protein design technology, which ThromboGenics licensed from Eleven Biotherapeutics in May.
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