August 2, 2013
ThromboGenics NV (Euronext Brussels: THR) a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces today that the German Institute for Quality and Efficiency in Health Care (IQWiG) has confirmed that JETREA
(ocriplasmin) demonstrates major / significant added value in VMT patients with mild / moderately severe symptoms compared with existing comparative treatment, when treating vitreomacular traction (VMT) including when associated with a macular hole of less than or equal to 400 microns.
is the first pharmacological treatment indicated for use in patients diagnosed with VMT and macular hole of diameter less than or equal to 400 microns. It was approved for this indication in the European Union in
. Partner Alcon launched the drug in
at the beginning of May.
There are no other pharmacological treatments in development for VMT. Currently patients either 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.
IQWiG is an independent federal organization that evaluates a drug's quality and efficiency, which makes a recommendation to the Federal Joint Committee (G-BA). G-BA is expected to issue final guidance on JETREA
IQWiG recognizes that the data submitted by ThromboGenics in the course of the value assessment provides an indication (
) for a major added value for VMT patients with mild symptoms and a significant added value for patients with moderately severe symptoms. Since the introduction of the Early Benefit Assessment in
, this is the very first time that IQWiG confirms an indication for a major added value (
Hinweis auf einen erheblichen Zusatznutzen
) for an innovative new drug substance.
Dr Patrik De Haes, CEO of ThromboGenics
s assessment confirming the significant additional benefits of
for VMT validates the importance of our novel drug in treating patients with this major sight-threatening disease. For the first time, patients can be treated at an earlier stage of their disease, rather than having to watch and wait until their symptoms worsen. We, and our partner Alcon, look forward to working with G-BA to ensure that the positive benefits shown by
are reflected in its final guidance.
Earlier this year, JETREA
was classified as a breakthrough innovation, the highest rating in the so-called 'Fricke and Klaus' assessment
. This assessment evaluates how innovative the mechanism of action of a new medicine is compared to existing therapies available in
contains the active substance ocriplasmin. It is administered through a single intravitreal injection to treat adults with vitreomacular traction (VMT).
VMT is a progressive, sight-threatening condition. It is caused by the vitreous humour having an abnormally strong attachment to the macula, the central part of the retina (the light sensitive membrane at the back of the eye). The macula provides central vision that is needed for everyday tasks such as driving, reading and recognizing faces.