Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

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
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 2,800+ scientific posters on ePosters
  • More Than 4,000+ 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 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 Announces FDA Acceptance of IND Application
FDA acceptance for Phase II study with JETREA® for the treatment of non-proliferative diabetic retinopathy (CIRCLE).
Tuesday, November 24, 2015
ThromboGenics and VIB Launch New Oncology Company
Oncurious NV to develop TB-403 for pediatric brain tumors.
Tuesday, April 14, 2015
Thrombogenics Awarded €1.1 Million IWT Research Grant
Grant to fund the on-going research to further elucidate the pharmacological effects of ocriplasmin.
Thursday, February 05, 2015
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 Awarded €3 Million IWT Grant
Grant funding to support research new therapeutic for diabetic macular edema.
Tuesday, March 11, 2014
ThromboGenics Initiates Major Post-Marketing Patient Trial with JETREA® in the US
ORBIT study designed to generate further data on the “real world” use of JETREA®.
Thursday, March 06, 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 Acquires Exclusive Rights from Bicycle Therapeutics
Collaboration and license agreement to develop and commercialize novel drugs inhibiting a target for DME.
Friday, September 06, 2013
ThromboGenics Licenses Innovative Technology from Eleven Biotherapeutics
Company to develop novel drugs for the treatment of diabetic eye diseases.
Friday, July 05, 2013
ThromboGenics Business Update
US sales through end of April 2013 have exceeded $10 million.
Monday, May 27, 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
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
Revolutionary Technologies Developed to Improve Outcomes for Lung Cancer Patients
Breath test to detect lung cancer brings oxygen directly to the wound.
NIH Supports New Studies to Find Alzheimer’s Biomarkers in Down Syndrome
Initiative will track dementia onset, progress in Down syndrome volunteers.
Dementia Linked to Deficient DNA Repair
Mutant forms of breast cancer factor 1 (BRCA1) are associated with breast and ovarian cancers but according to new findings, in the brain the normal BRCA1 gene product may also be linked to Alzheimer’s disease.
Using Drug-Susceptible Parasites to Fight Drug Resistance
Researchers at the University of Georgia have developed a model for evaluating a potential new strategy in the fight against drug-resistant diseases.
Boosting Breast Cancer Treatment
To more efficiently treat breast cancer, scientists have been researching molecules that selectively bind to cancer cells and deliver a substance that can kill the tumor cells, for several years.
New Gene Map Reveals Cancer’s Achilles’ Heel
Team of researchers switches off almost 18,000 genes
New Discovery Sheds Light on Disease Risk
Gaps between genes interact to influence the risk of acquiring disease.
How Cells ‘Climb’ to Build Fruit Fly Tracheas
Mipp1 protein helps cells sprout “fingers” for gripping.
Research Finding Could Lead to Targeted Therapies for IBD
Findings published online in Cell Reports.
Scroll Up
Scroll Down
Skyscraper Banner

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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos