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ThromboGenics' JETREA® Receives Positive Initial NICE Recommendation For Vitreomacular Traction And Macular Hole

LEUVEN, Belgium, June 12, 2013 /PRNewswire/ --

ThromboGenics NV (Euronext Brussels: THR) a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces today that the UK's National Institute for Health and Care Excellence (NICE) has provisionally recommended JETREA ® (ocriplasmin) for reimbursement within the National Health Service (NHS). The NICE Appraisal Consultation Document (ACD) initially recommends JETREA ® as an option for treating vitreomacular traction (VMT) in adults, including when associated with a macular hole of less than or equal to 400 microns, when patients have severe symptoms and an epiretinal membrane is not present.

JETREA ® 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 and was approved in the European Union by the European Commission in March 2013. Partner Alcon launched the drug in the UK, its first market in Europe, in April, resulting in ThromboGenics receiving €90 million in milestone payments. Alcon, a division of Novartis, acquired the rights to commercialize JETREA ® outside the United States in March 2012.

The NICE appraisal committee considers evidence submitted by the manufacturer and makes a judgment on whether or not the technology should be recommended as a clinically and cost-effective use of NHS resources, or whether it should only be recommended for specific subgroups of patients. This process also takes into account testimony from clinical experts, patient groups and carers.

After publication of the ACD, NICE invites formal consultees, commentators and the general public to comment on the ACD. After considering these comments, the Committee then finalizes its recommendations and submits them to NICE in the form of a Final Appraisal Determination (FAD). The final NICE guidance on JETREA ® is expected in the third quarter of 2013.

Dr Patrik De Haes, CEO of ThromboGenics, said: " We are delighted by the preliminary NICE recommendation for  JETREA ® , the first and only pharmacological treatment licensed for VMT and macular hole. The Institute has concluded that treatment with  JETREA ®   early in the course of the disease represents a step-change in how patients with VMT are currently managed, preserving visual function and quality of life for patients with this distressing, sight-threatening condition. We particularly welcome NICE ' s endorsement that  JETREA ®   is a cost-effective use of finite NHS resources, and represents good value for money in the patients in whom it is recommended. "

" People affected by VMT and macular hole can suffer significant vision distortion that can make it difficult for them to read, watch TV and drive. The draft NICE recommendation published today is important in improving their treatment options. For suitable patients it offers a simple treatment that may avoid the need for eye surgery, and means patients unsuited to surgery can now be treated, often before their condition deteriorates, " said Mr Tim Jackson, Consultant Retinal Surgeon at King's College Hospital.

JETREA ® 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.

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