Vitreomacular Traction Treatment JETREA(R) Gains EU ApprovalMain Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Mar 2013 - 1:00 PDT
Vitreomacular Traction Treatment JETREA(R) Gains EU Approval
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ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, has announced that the European Commission has approved JETREA(R) (ocriplasmin) in the European Union.
JETREA(R) is approved for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. The EU approval triggers a EUR45 million milestone payment to ThromboGenics from its partner Alcon. The first sale of JETREA(R) in the EU by Alcon will trigger a further EUR45 million milestone payment to ThromboGenics.
Alcon, a division of Novartis, acquired the rights to commercialize JETREA(R) outside the United States in March 2012. ThromboGenics retains the right to commercialize the drug in the US. ThromboGenics launched JETREA(R) in the US in mid-January 2013 where it is approved for the treatment of patients with symptomatic vitreomacular adhesion (VMA).
Dr Patrik De Haes, CEO of ThromboGenics, says: "The European approval of JETREA(R) 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 VMA. Today's approval has triggered a EUR45 million milestone payment to ThromboGenics. We also anticipate a further EUR45 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 surgery."
JETREA(R) contains the active substance ocriplasmin. It is administered through a one-time, single intravitreal injection to treat adults with vitreomacular traction (VMT).
VMT, which in the US is referred to as symptomatic VMA, is an age-related progressive, sight-threatening condition. It is caused by the vitreous humour having an abnormally strong attachment to 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 recognising faces.
When the vitreous humour shrinks, the strong attachment results in a pulling force on the retina, which may lead to visual distortion, decreased visual acuity and central blindness. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).
JETREA(R) breaks down the protein fibers which cause the abnormal traction between vitreous and macula that causes VMT. By dissolving these proteins, JETREA(R) releases the traction, and helps to complete the detachment of the vitreous from the macula.
JETREA(R) can also be used when VMT has progressed and caused a small hole in the macula (central part of the light-sensitive layer at the back of the eye). It is estimated that 250,000 to 300,000 patients in Europe alone suffer from this condition.
Currently the only available treatment in the EU is 'observation' or 'watchful waiting' until a patient becomes a surgical candidate, usually at a late stage of the disease., A patient would then receive a surgical procedure and repair of the retina. However, for many patients this is not a suitable option, as irreversible damage to the retina may have already occurred.,
ThromboGenics is continuing to work with Alcon, across Europe, to ensure the necessary market access and reimbursement infrastructure in place so that patients can receive JETREA(R) as soon as it is available.
"Vitreomacular traction and macular hole formation are disabling eye diseases that influence visual function, and affect activities of patients in their daily life," said Prof. Dr. Peter Stalmans, Department of Ophthalmology, UniversityHospitals, Leuven, Belgium. "When the disease worsens, vitrectomy surgery is the only available treatment option. Release of the vitreous traction by pharmacologic vitreolysis can omit the need for vitrectomy.
"The EU approval of JETREA(R) is a very positive development for patients with VMT and the wider European retina community. This novel pharmacological approach will enable us to improve the treatment of VMT by allowing patients to be treated earlier thereby avoiding the deterioration in their condition that takes place during watchful waiting as well as the risks associated with the surgery. I am looking at quickly integrating the use of JETREA(R) into my clinical practice as soon as it becomes available."
The EU MAA submission was based on data from two pivotal phase III clinical trials that evaluated the safety and efficacy of a single administration of JETREA(R). Both studies met their primary endpoint and demonstrated that JETREA(R) successfully resolved VMT and macular holes compared to placebo.
All adverse reactions were ocular. The most commonly reported were vitreous floaters, eye pain and photopsia, as well as conjunctival haemorrhage resulting from the injection procedure. Most of the adverse reactions occurred within the first week after the injection. The majority of these reactions were non-serious, mild in intensity and resolved within 2 to 3 weeks.
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. Dugel PU, Brown DM, Humayun MS et al. Symptomatic vitreomacular adhesion: diagnosis, pathologic implications, and management. Retina Today 2011;(Suppl):1-14
. Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med 2012;367:606-615
22 May. 2013. <http://www.medicalnewstoday.com/releases/257800.php>
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