LEUVEN, Belgium, October 17, 2013 /PRNewswire/ --
Decision confirms therapeutic benefits for treatment of VMT patients suffering from mild and moderate symptoms , or 94% of the indicated VMT population
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces today that the Final Early Benefit Assessment from the German Federal Joint Committee (G-BA) has concluded that JETREA ® (ocriplasmin) demonstrates significant added benefit for VMT patients with mild and moderate symptoms when compared with existing comparative treatment (watchful waiting). The mild to moderate VMT population, as referred to by G-BA in its final assessment, represents the vast majority (94%) of the total patient population covered by the approved label.
G-BA is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. Since the introduction of the early benefit assessment procedure in Germany in January 2011, G-BA has assessed more than sixty innovative new drugs. JETREA ® is to-date one of only six innovative medicines appraised by G-BA to provide significant additional therapeutic benefits for patients.'Significant' demonstrates a sustained and large improvement in the therapy-relevant benefit. In its assessment, G-BA particularly considered the potential improvement in visual acuity and the avoidance of surgery in the back of the eye by JETREA ® as beneficial for patients. G-BA's final guidance confirms the recommendation made by the German Institute for Quality and Efficiency in Health Care (IQWiG) in August 2013. IQWiG is an independent federal organization that evaluates a drug's quality and efficiency and makes recommendations to G-BA. "Given the low risk profile of the injection , it is now possible to intervene in patients with VMT at a very early stage" , says Prof. Dr. Anselm Kampik , Director of the eye clinic of the University of Munich (LMU). "Many early stage patients still have a good visual function which , with a timely intervention , can be preserved , or even improved. So a better functional outcome can be expected , than when only treating the patient after a period of watchful waiting." Dr Patrik De Haes , CEO of ThromboGenics, said: " The confirmation from G-BA that JETREA ® represents a significant value treatment for patients with mild VMT is a very positive development. For the first time , patients can be treated early , meaning that they can avoid the adverse consequences of the current watch and wait approach. With the NICE FAD in the UK also supporting the use of JETREA ® in patients with the early symptoms of VMT such as metamorphopsia , our partner Alcon now has a solid platform to start building the European sales of this innovative new drug in the largest population of VMT patients. " JETREA ® is the first pharmacological treatment indicated for use in patients diagnosed with VMT, also when associated with macular hole of diameter less than or equal to 400 microns. It was approved for this indication in the European Union in March 2013. ThromboGenics' commercial partner Alcon launched the drug in Germany at the beginning of May. There are no other pharmacological treatments available for this condition. At present, patients have to watch and wait before they are considered eligible for surgery. Surgery is typically performed only at a later stage of a patient's disease, once symptoms progress and their sight deteriorates significantly.