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National Institute For Health And Care Excellence (NICE) In The UK Recommends Reimbursing ThromboGenics' JETREA® For Treatment Of A Broad Range Of Patients With Vitreomacular Traction (VMT), Including When Associated With Macular Hole

LEUVEN, Belgium, October 23, 2013 /PRNewswire/ --

Final guidance confirms metamorphopsia, an early symptom of VMT, as severe and distressing, requiring early treatment

  • NICE final guidance recommends reimbursement of JETREA for treatment of a broad range of VMT patients, from early stage to late-stage: patients with epiretinal membranes (ERMs) are excluded
  • NICE recommends reimbursement for patients suffering from VMT with full thickness macular hole (FTMH) < 400 microns
  • NICE recommends reimbursement of JETREA for treatment of patients showing early symptoms of VMT such as metamorphopsia (blurred vision); NICE considers patient impact of metamorphopsia to be equal to the loss of two lines in visual acuity

ThromboGenics NV (Euronext Brussels: THR) a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces that the UK's National Institute for Health and Care Excellence (NICE) final guidance has recommended that JETREA ® (ocriplasmin) should be reimbursed within the National Health Service (NHS) in England and Wales as an option for treating VMT patients. JETREA has been marketed by ThromboGenics partner, Alcon, mainly to private hospitals in the UK since April 2013.            

The NICE final guidance again highlighted metamorphopsia as a 'severe and distressing' symptom, with its impact on the patient being comparable to a loss of two lines in visual acuity. In its final ruling NICE has recommended reimbursing JETREA when used to treat patients suffering from metamorphopsia, one of the early signs of VMT.

Currently patients with VMT are observed (termed watch and wait) before they are considered eligible for surgery. Surgery is only performed at a later stage of a patient's disease, once symptoms progress and their sight deteriorates significantly.  

Dr Patrik De Haes, CEO of ThromboGenics, said: " We are very pleased with NICE ' s final guidance recommending that the NHS in England and Wales should reimburse the use of  JETREA ®   for a broad range of patients with VMT and macular hole. This outcome marks the start of a paradigm shift in treatment as it means that physicians will be able to use the first and only pharmacological option to proactively treat this progressive disease much earlier and as soon as patients start experiencing symptoms such as metamorphopsia.

"NICE's view that metamorphopsia is a 'severe and distressing' symptom and that early treatment with J ETREA ®   should be reimbursed is in line with our own view that this novel drug delivers significant clinical and quality of life benefits to patients with VMT.  

"There is growing evidence that if left untreated prolonged VMT may lead to progressive vision loss and importantly, an increased risk that subsequent intervention may be less successful. With JETREA ® , an innovative new drug, we believe that patients will be able to benefit, for the first time, by having access to a reimbursed alternative to watchful waiting. We are confident that today's NICE recommendation will lead to a significant change in the way this important sight-threatening condition is treated in the UK. "  

"People affected by vitreomacular traction can suffer vision changes that have a significant impact on their lives, making it difficult to do everyday activities like reading, watching TV and driving, " said Tim Jackson, Retinal Surgeon at King's College Hospital. " Until now, eye doctors have only had surgical options to treat this disease, once it progressed to a severe stage. This new treatment is a welcome advance, meaning some patients can now avoid surgery, and others who might not be suitable for surgery can now be treated. "

JETREA ® is the first and only potentially curative pharmacological treatment indicated for use in patients diagnosed with VMT, including when associated with 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. Alcon, a division of Novartis, acquired the rights to commercialize JETREA ® outside the United States in March 2012. In April 2013, Alcon launched JETREA ® in the UK, its first market in Europe, resulting in ThromboGenics receiving €90 million in milestone payments.

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 humor 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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