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UK's NICE Final Appraisal Determination (FAD) Confirms Positive Recommendation For ThromboGenics' JETREA® For Treatment Of Vitreomacular Traction And Macular Hole

Stocks in this article: THR

LEUVEN, Belgium, September 2, 2013 /PRNewswire/ --

  Metamorphopsia confirmed as a severe and distressing symptom deserving immediate attention and early treatment with reimbursement

  • NICE FAD recommending reimbursement of JETREA for treatment of VMT patients, from early stage to late-stage (full thickness macular hole (FTMH) < 400 microns), when severe and distressing symptoms; patients with ERMs are excluded
  • NICE FAD recommending reimbursement of JETREA for treatment of patients showing symptoms of metamorphopsia (blurred vision); metamorphopsia patient impact considered severe and distressing, and equal to loss of 2 lines in visual acuity
  • Confirmation of reimbursement for patients suffering from VMT with FTMH < 400 microns

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) has confirmed, in its Final Appraisal Determination (FAD), its recommendation that JETREA ® (ocriplasmin) is an innovative new treatment and should be reimbursed within the National Health Service (NHS) in England and Wales.

The NICE FAD confirms NICE's earlier Appraisal Consultation Document (ACD), which initially recommended 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.

In its Final Appraisal Determination, NICE for the first time also characterized metamorphopsia as a 'severe and distressing' symptom with its impact on the patient being comparable to a loss of 2 lines in visual acuity.

As a result, NICE not only recommends full reimbursement of JETREA ® for patients with VMT and FTMH, smaller or equal to 400 microns, it also recommends reimbursement for those VMT patients with early stage VMT symptoms including  metamorphopsia.  

There are no other pharmacological treatments in development for the treatment of VMT. Currently patients either have to 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.  

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