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

ThromboGenics Initiates Major Post-Marketing Patient Trial with JETREA® in the US

Published: Thursday, March 06, 2014
Last Updated: Thursday, March 06, 2014
Bookmark and Share
ORBIT study designed to generate further data on the “real world” use of JETREA®.

ThromboGenics NV has announced that it is to shortly initiate a US Phase IV study with JETREA®. The Ocriplasmin Research to Better Inform Treatment (ORBIT) study is designed to generate further data on the real-world use of JETREA®.

The ORBIT study will recruit 1,500 patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) patients across 120 retina centers in the US. The prospective, observational study will assess clinical outcomes and safety of JETREA® administered in a real-world setting for the treatment of symptomatic VMA/VMT by assessing both anatomical and functional outcomes.

The study will look at a number of parameters including resolution of VMA, Full Thickness Macular Hole (FTMH) closure, changes in visual acuity (VA) and occurrence and time to vitrectomy. It will also monitor adverse drug reactions (ADRs) and changes from baseline in ocular signs and symptoms across time. These data will further characterize the efficacy and safety profile of the product and provide data complementary to those from the phase III clinical program and its first year on the market.

Patients will be followed for up to 12 months following treatment with JETREA®. The ORBIT study is expected to start recruiting patients this month and is due to complete in mid-2016.

Dr Patrik De Haes, CEO of ThromboGenics, comments: “The start of the ORBIT study in the US reflects ThromboGenics’ commitment to gain further knowledge on the real world use of JETREA®. We feel that it is important with such a novel treatment option as JETREA® to conduct a significant post marketing study in order to assess which patients gain the greatest benefit from the first pharmacological option that is designed for the treatment of symptomatic VMA/VMT. The desire for more information on the real-world experience with JETREA® is shared by our partner Novartis/Alcon which is conducting a parallel patient study outside the US.”


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 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 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 Business Update
US sales through end of April 2013 have exceeded $10 million.
Monday, May 27, 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
ThromboGenics NV - Business Update
Company to build a first-class US commercial organization to launch JETREA in January 2013.
Friday, November 09, 2012
ThromboGenics NV - Business Update
ThromboGenics sign an important strategic deal with Alcon.
Monday, October 22, 2012
U.S. FDA Approves ThromboGenics’ JETREA® (Ocriplasmin)
JETREA® is the first pharmacological agent approved for the treatment of symptomatic VMA.
Thursday, October 18, 2012
ThromboGenics Announces Publication of New England Journal of Medicine Paper
Paper highlights that ocriplasmin is superior to placebo in resolving VMT and closing macular holes in patients with VMA.
Saturday, September 15, 2012
ThromboGenics and BioInvent Announce Results from Phase IIb VTE Prevention Study with TB-402
All further development of TB-402 will be stopped.
Thursday, July 05, 2012
ThromboGenics and BioInvent Complete Enrolment of Phase IIb Trial with TB-402 Ahead of Schedule
The companies announced they have completed the enrolment of a 632-patient Phase IIb trial with their long-acting anticoagulant TB-402 (factor VIII inhibitor).
Friday, December 16, 2011
ThromboGenics Announces that Microplasmin Meets Primary Endpoint in Phase III Trial for VMA
Highly significant trial result demonstrates the potential of microplasmin in the treatment of retinal disease.
Monday, April 26, 2010
ThromboGenics Announces Results From a Phase IIa Trial Evaluating Microplasmin for the Treatment of Diabetic Macular Edema (MIVI II DME)
ThromboGenics NV announces results of a Phase IIa trial evaluating microplasmin intravitreal injection for the treatment of Diabetic Macular Edema (MIVI II DME). The data from this trial were presented at the ASRS (American Society of Retina Specialists) Conference in New York on 3 October, 2009 by Professor Peter Stalmans, University Hospitals Leuven, Belgium.
Friday, October 09, 2009
ThromboGenics Completes Patient Enrolment for Phase II Trial of Microplasmin for the Treatment of DME
The MIVI II DME trial is a Phase II clinical trial evaluating the safety and initial efficacy of intravitreal microplasmin for the treatment of DME patients.
Monday, March 09, 2009
Scientific News
Therapy Halts Progression of Lou Gehrig’s Disease
Researchers at Oregon State University announced today that they have essentially stopped the progression of amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, for nearly two years in one type of mouse model used to study the disease – allowing the mice to approach their normal lifespan.
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.
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.
UTSW Researchers Identifies How Drugs Alter Pancreatic Cancer Cells
The findings were published in Cell Reports.
Researchers Identify Process that Causes Chronic Neonatal Lung Disease
Study determines how the NLRP3 inflammasome activates the protein Interleukin 1 beta.
Dengue Vaccine Enters Phase 3 Trial
Investigational vaccine to prevent ‘breakbone fever’ developed at NIH.
Trying to Conceive Soon After a Pregnancy Loss May Increase Chances of Live Birth
NIH study finds no reason for delaying pregnancy attempts after a loss without complications.
BRCA1 Deficiency Increases the Sensitivity of Ovarian Cancer Cells to Auranofin
An anti-rheumatic drug could improve the prognosis for ovarian cancer patients exhibiting a deficiency of the DNA repair protein BRCA1, a study suggests.
Shingles Vaccine Helps Protect Older Patients with End-stage Renal Disease
Kaiser Permanente study advances knowledge about safety and effectiveness of vaccine commonly given to older adults.
AMRI Acquires Whitehouse Laboratories
Strategically extends AMRI's analytical offerings in rapidly expanding area of outsourcing services.
Scroll Up
Scroll Down
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!