Jetrea Granted EU Approval for Vitreomacular Traction - Pharmaceutical Technology

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Jetrea Granted EU Approval for Vitreomacular Traction



ThromboGenics' eye drug, Jetrea (ocriplasmin) has been approved in the EU for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. The approval triggered a €45 million milestone payment to ThromboGenics from partner Alcon, a division of Novartis. ThromboGenics also stands to receive another €45 million from first sales of the drug after the EU launch by Alcon. Alcon acquired rights to commercialize Jetrea outside the US in March 2012. ThromboGenics retains marketing rights in the US.

"The European approval of Jetrea just weeks after the US launch is another major milestone for the company as we maintain, with our partner Alcon, the momentum of the global roll out of this novel pharmacological treatment for symptomatic vitreomacular adhesion (VMA). Today’s approval has triggered a €45 million milestone payment to ThromboGenics. We also anticipate a further €45 million as a result of Alcon’s first sale of the product in the EU which is expected to take place soon. Patients across Europe will now have access to our innovative drug for an important sight-threatening condition. VMT is a considerable unmet medical need and places a huge burden on patients across Europe who until now have had no treatment option other than watchful waiting or surger," said Dr Patrik De Haes, CEO of ThromboGenics, in a press statement.

Jetrea is administered through as a one-time, single intravitreal injection to treat adults with VMT or symptomatic VMA, which is an age-related progressive, sight-threatening caused by the vitreous humour having an abnormally strong attachment to the central part of the retina. The macula provides central vision for daily tasks such as driving, reading and recognising faces. When the vitreous humour shrinks, the strong attachment causes a pulling force on the retina that could lead to visual distortion, decreased visual acuity and central blindness. As the disease progresses, the traction may eventually result in the formation of a hole in the macula, known as a macular hole.

Jetrea works by breaking down the protein fibers that are responsible for the abnormal traction between vitreous and macula. The drug releases the traction by dissolving these proteins, thereby helping to complete the detachment of the vitreous from the macula.

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