October 17, 2013
therapeutic benefits for
treatment of VMT patients suffering from
mild and moderate symptoms
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
. Since the introduction of the early benefit assessment procedure in
, 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
. 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"
Prof. Dr. Anselm Kampik
Director of the eye clinic of the
"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
The confirmation from G-BA that
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
also supporting the use of
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.
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
. ThromboGenics' commercial partner Alcon launched the drug in
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.