November 27, 2012
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that JETREA
(ocriplasmin) has been selected to receive a Single Technology Appraisal (STA) from the UK's National Institute for Health and Clinical Excellence (NICE). The outcome of the STA, in the form of NICE guidance, is expected later in 2013, following the launch of JETREA
in the UK.
European Marketing Authorisation Application is currently under review by the European Medicines Agency. A decision on European approval is expected in the first half of 2013. JETREA
was recently approved by the U.S. Food and Drugs Administration for the treatment of symptomatic Vitreomacular Adhesion (VMA). In
, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside
the United States
The NICE STA process is designed to provide recommendations on the use of new medicines in the National Health Service (NHS). The STA is specifically designed to appraise a single product with a single indication, and enables NICE to produce guidance soon after the technology is introduced in the UK. During the appraisal process, NICE seeks evidence from several sources. ThromboGenics and its partner Alcon, will submit the principal evidence for the JETREA
STA shortly. This submission will be assessed by an Evidence Review Group (ERG), an external independent academic organization, which will produce a review of the evidence submission. The STA also relies on information and evidence from clinical consultants, and NHS commissioning authorities as well as patient groups.
Dr Patrik De Haes, CEO at ThromboGenics
"We are delighted that the
Department of Health has asked NICE to appraise
for the treatment of vitreomacular traction
. We strongly believe that JETREA
has the potential to dramatically change the treatment paradigm in the
for this progressive sight threatening condition".
We plan to submit, along with our partner Alcon, our dossier for the STA shortly and look forward to working with NICE and all parties involved in the appraisal process.
(ocriplasmin) is a truncated form of human plasmin for the treatment of symptomatic VMA. JETREA
is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and
involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
's Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA
was generally well tolerated with most adverse events being transient and mild in severity.