ThromboGenics Receives US FDA Approval for New 'Already-Dilu
ThromboGenics Receives US FDA Approval for New 'Already-Diluted' Formulation of JETREA®
LEUVEN , Belgium , June 8, 2016 /PRNewswire/ --
ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on developing novel medicines for back of the eye disease, today announces that the Office of Biotechnology Products of the U.S. Food and Drug Administration (FDA) has approved a new already-diluted formulation of its JETREA ® (ocriplasmin ).
The new formulation of JETREA ® offers the additional benefit of eliminating the current preparatory dilution steps prior to injection. At the point of administration into the eye, the strength, potency, composition and pharmaceutical form of the already-diluted formulation remain identical to the currently available formulation after dilution.
JETREA ® is approved in the USA for the treatment of symptomatic vitreomacular adhesion (VMA), an age-related progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness .
ThromboGenics Inc., which is commercializing JETREA ® in the US, plans to launch the already-diluted formulation of JETREA® in the first half of 2017.
ThromboGenics is a biopharmaceutical company focused on developing innovative treatments for diabetic eye disease. The company's attractive pipeline of disease modifying drug candidates is targeting the key segments of the diabetic eye disease market.
ThromboGenics is conducting the CIRCLE study, a Phase II clinical trial to assess THR-409 (ocriplasmin ) as a potential treatment to prevent the patients with non-proliferative diabetic retinopathy progress to proliferative diabetic retinopathy. The study is recruiting patients in the US, Canada and Europe.
THR-317 , a PIGF inhibitor being developed to treat diabetic macular edema, or as a combination therapy with anti-VEGF treatments, is expected to enter the clinic by year end 2016. In addition, THR-149 , a plasma kallikrein inhibitor, which has resulted from research collaboration with Bicycle Therapeutics , and THR-687 , an integrin antagonist , which was in-licensed from Galapagos are in late stage pre-clinical development.
ThromboGenics pioneered the new drug category of pharmacological vitreolysis with JETREA ® (ocriplasmin ) which is now approved for the treatment of vitreomacular traction in 54 countries worldwide. ThromboGenics is commercializing JETREA ® via its subsidiary ThromboGenics , Inc. in the US. Novartis commercializes JETREA ® outside the United States.
ThromboGenics is headquartered in Leuven , Belgium , and is listed on the NYSE Euronext Brussels exchange under the symbol THR.
More information is available at www.thrombogenics.com