LEUVEN, Belgium, January 18, 2013 /PRNewswire/ --
Positive opinion clears the way for the potential EMA approval of JETREA ® as the first pharmacological option for the tr eatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for JETREA ® (ocriplasmin), recommending JETREA ® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
VMT, in the US referred to as symptomatic VMA, is an age-related progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness. It is estimated that 250,000 to 300,000 patients in Europe alone suffer from this condition. [ 1 ]JETREA ®, a recombinant form of a human protein (plasmin), is administered through a one-time, single intravitreal injection. It targets the protein fibers which cause the abnormal pulling between vitreous and macula that causes VMT. By dissolving these proteins, JETREA ® releases the traction, and helps to complete the detachment of the vitreous from the macula. Alcon, a division of Novartis, acquired the rights to commercialize JETREA ® outside the United States in March 2012. ThromboGenics retains the rights to commercialize the drug in the US. In the US, JETREA ® has received FDA approval for the treatment of patients with symptomatic vitreomacular adhesion (VMA). Earlier this week, ThromboGenics introduced JETREA ® in the US. The first patients have already received this novel treatment in multiple locations across the country. " We are very pleased that the CHMP has provided a positive recommendation for JETREA ® for the treatment of VMT, including when associated with macular holes, " says Dr Patrik De Haes, CEO of ThromboGenics. " With our partner Alcon, ThromboGenics, as the marketing authorization holder, will continue to work with the European Medicines Agency and the European Commission as it finalizes the JETREA ® European Marketing Authorization Application. Today, more than ever, we are convinced that VMT is an area of unmet medical need. With today ' s positive CHMP opinion, we anticipate a final decision by the European Commission within the next 2 to 3 months. The decision will be applicable to all 27 European Union Member states plus Iceland and Norway . Upon the Commission ' s final approval and completion of pricing and reimbursement, we intend to support our partner Alcon in making this novel treatment option available to patients in the EU as soon as possible, " De Haes concludes. JETREA ® is used to treat adults with an eye disease called vitreomacular traction (VMT), including when it is associated with a small hole in the macula (central part of the light-sensitive layer at the back of the eye). VMT is caused by traction resulting from a persistent attachment of the vitreous (jelly-like material in the center of the eye) to the macula at the back of the eye. The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces. VMT can cause symptoms such as distorted or decreased vision. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).