Corporate Banner
Satellite Banner
Medicinal Chemistry
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

ThromboGenics’ JETREA® Granted EU Approval for VMT

Published: Monday, April 15, 2013
Last Updated: Monday, April 15, 2013
Bookmark and Share
EU approval of JETREA® triggers a €45 million milestone payment from Alcon.

ThromboGenics NV has announced that the European Commission has approved JETREA® (ocriplasmin) in the European Union.

JETREA® 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 €45 million milestone payment to ThromboGenics from its partner Alcon.

The first sale of JETREA® in the EU by Alcon will trigger a further €45 million milestone payment to ThromboGenics.

Alcon, a division of Novartis, acquired the rights to commercialize JETREA® outside the United States in March 2012.

ThromboGenics retains the right to commercialize the drug in the US. ThromboGenics launched JETREA® 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® 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 €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 surgery.”

JETREA® 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 recognizing 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® breaks down the protein fibers which cause the abnormal traction 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.

JETREA® can also be used when VMT has progressed and caused a small hole in the macula (central part of the lightsensitive 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® 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, University Hospitals, 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® 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® into my clinical practice as soon as it becomes available.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,900+ scientific posters on ePosters
  • More than 4,200+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

ThromboGenics Appoints Dominique Vanfleteren as New CFO
Dominique has over 25 years of experience in senior finance, operational, control and reporting roles.
Saturday, January 17, 2015
ThromboGenics’ JETREA® Gains First Asian Approval in Malaysia
JETREA® (ocriplasmin) has been approved for the treatment of adults with vitreomacular traction.
Tuesday, April 22, 2014
ThromboGenics’ JETREA® Receives Positive Common Drug Review in Canada
CDR provides formulary listing recommendations to Canada’s publicly funded drug plans.
Monday, December 30, 2013
ThromboGenics Appoints Dr David Guyer to its Board of Directors
Dr Guyer is currently the Co-Founder and Chief Executive Officer of Ophthotech Corporation.
Monday, December 23, 2013
ThromboGenics’ Founder Prof Desire Collen Retiring as Chairman
Dr Staf Van Reet appointed as new Chairman of the Board.
Monday, December 09, 2013
ThromboGenics’ JETREA® Available in Germany Public and Private Market
Company could receive a further €210 million in milestones plus significant royalties.
Friday, May 03, 2013
ThromboGenics Receives Positive CHMP Opinion for JETREA®
Positive opinion clears the way for the potential EMA approval of JETREA® as the first pharmacological option for the treatment of VMT, including when associated with macular hole of diameter less than or equal to 400 microns.
Wednesday, April 24, 2013
JETREA® Selected for Single Technology Appraisal by UK’s NICE
The outcome of the STA is expected later in 2013.
Monday, March 25, 2013
ThromboGenics Announces Business Update and 2012 Full-Year Results
Transformational 2012 delivers euro 30 million in net profit.
Tuesday, March 19, 2013
Scientific News
Spero Therapeutics Announces $30 Million Series B Preferred Financing
Company has announced financing of $30 million to support development of novel therapies to treat gram-negative bacterial infections.
Keeping Tumor Growth at Bay
Engineers at Washington University in St. Louis found a way to keep a cancerous tumor from growing by using nanoparticles of the main ingredient in common antacid tablets.
Future of Medicine Could be Found in a Tiny Crystal Ball
A Drexel University materials scientist has discovered a way to grow a crystal ball in a lab. Not the kind that soothsayers use to predict the future, but a microscopic version that could be used to encapsulate medication in a way that would allow it to deliver its curative payload more effectively inside the body.
Improving Delivery of Poorly Soluble Drugs Using Nanoparticles
A technology that could forever change the delivery of drugs is undergoing evaluation by the Technology Evaluation Consortium™ (TEC). Developed by researchers at Northeastern University, the technology is capable of creating nanoparticle structures that could deliver drugs into the bloodstream orally – despite the fact that they are normally poorly soluble.
Faster Drug Discovery?
Startup develops more cost-effective test for assessing how cells respond to chemicals.
New Mechanism of Antitumor Action Identified
A team of UAB researchers and collaborators from the Catalan biotech company Ability Pharmaceuticals (UAB Research Park), have described a new mechanism of anti-tumour action, identified during the study and development of the new drug ABTL0812.
Nanoparticles Deliver Tumor Suppressors to Damaged Livers
UT Southwestern Medical Center chemists have successfully used synthetic nanoparticles to deliver tumor-suppressing therapies to diseased livers with cancer, an important hurdle scientists have been struggling to conquer.
Experimental Combination Surprises with Anti-HIV Effectiveness
A compound developed to protect the nervous system from HIV surprised researchers by augmenting the effectiveness of an investigational antiretroviral drug beyond anything expected.
A New Type of Anticancer Agent
Success in the development of a ?-tubulin specific inhibitor.
Nanoparticles Proven Effective Against Antibiotic-Resistant “Superbugs”
In the ever-escalating evolutionary battle with drug-resistant bacteria, humans may soon have a leg up thanks to adaptive, light-activated nanotherapy developed by researchers at the University of Colorado Boulder.
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!