Administrative guidelines precertification is required. Thrombogenics, leuven, belgium the only management options for symptomatic vmt and fullthickness macular hole. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. At oxurion we are dedicated to developing innovative treatments to preserve vision for patients with diseases affecting the back of the eye. It is a truncated form of the natural human protein plasmin, an enzyme that dissolves protein formations that are crucial to blood clot thrombus formation. Since that time, we now have about a 95% success rate in terms of closure of macular holes, he said. Novartis, thrombogenics eye drug jetrea gets green light in eu first drug specifically approved for vitreomacular adhesion novartis has bolstered its ophthalmology portfolio in the eu after winning approval for jetrea, the first drug specifically cleared for the eye disorder vitreomacular adhesion vma.
Some of the dosage forms listed on this page may not apply to the brand name jetrea in summary. Novartis, thrombogenics eye drug jetrea gets green light. Ocriplasmin not as costeffective as vitrectomy for. Thrombogenics, inc, is a subsidiary of oxurion nv full story. Thrombogenics nv, novartis ag win eu ok for jetrea eye drug read this article along with other careers information, tips and advice on biospace. Thrombogenics nv, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, has received malaysian approval for its jetrea ocriplasmin for the treatment of adults with vitreomacular traction vmt, including when associated with macular hole of diameter less than or equal to 400 microns. Shechtman is a member of thrombogenics optometric advisory board. The first nonsurgical alternative to eye surgery for a visionthreatening problem that affects approximately 250,000 people a year in the united states, is now available, jetrea. Thrombogenics is conducting a phase ii clinical study evaluating thr 317, a plgf inhibitor for the treatment of diabetic macular edema, as a standalone or as a. Vmt is often responsible for progressive sightthreatening.
European union approves thrombogenics jetrea for the. This document contains side effect information about ocriplasmin ophthalmic. Alcon and thrombogenics announce eu approval of pichia. Ocriplasmin for treating vitreomacular traction this guidance was developed using the single technology sta process. Macular hole treatment with jetrea ocriplasmin in england suzi is a 47 year old woman living in england. Jetrea ocriplasmin is an alpha2 antiplasmin reducer. The approval was based on the data from thrombogenics phase iii program where jetrea was shown to be superior to placebo for the treatment of symptomatic vma 26. Vitrectomy yields more macular hole closures than jetrea.
Thrombogenics is continuing to work closely with alcon to ensure patients across europe and rest of the world can access this innovative medicine and receive jetrea as soon as it becomes available in the respective countries. Jetrea receives positive chmp opinion hospital pharmacy. The mivitrust trial showed that macular holes closed in 40. Thrombogenics initiated phase ii clinical trials on jetrea in october 2011. Jetrea was approved by the us food and drug administration fda for treating symptomatic vma in october 2012. Whether you are a candidate for jetrea depends on the status of the vitreous and the size of the macular pucker. Watch the thrombgenics team discuss the companys commitment to the retina community and patients.
Ocriplasmin not as costeffective as vitrectomy for vitreomacular. Symptomatic vma is becoming increasingly recognized as a sightthreatening disease related to aging. Jetrea is the first pharmacological treatment indicated for use in patients diagnosed with vmt and macular hole of diameter less than or equal to 400 microns and was approved in the european union by the european commission in march 20. Aetna considers ocriplasmin jetrea medically necessary for the treatment of symptomatic vitreomacular adhesion vma of at least 6. Your eye care professional may have talked to you about your vision changes and a treatment option called jetrea ocriplasmin injection, for intravitreal injection, 1.
Thrombogenics plays long game for eye disease thrombogenicss expansion from the small neighborhood of vitreomacular adhesion to the big city of diabetic macular edema is a solid long term. After reading this blog she wrote to say that she had also had an injection of jetrea to treat a small macular hole. Ocriplasmin is approved for pharmacologic vitreolysis of symptomatic vma. The company has built a diverse portfolio of diseasemodifying therapies, including treatments for diabetic eye disease, a. Ocriplasmin is a recombinant truncated form of human plasmin with a molecular weight of 27. Jetrea ocriplasmin for treatment of symptomatic vitreomacular. It works by dissolving the proteins that link the vitreous to the macula. As can be seen in the oct image, when the vitreous sticks to the macula of a patient with symptomatic vma, it can start pulling on it. Unfortunately she hadnt been able to do so as although another woman presented with a macular hole, she didnt fit the characteristics which determine the most likely success with ocriplasmin. You are encouraged to report side effects of prescription drugs to the fda. Oxurion owns the global rights to jetrea ocriplasmin, the only pharmacological vitreolysis drug approved for the.
The fda recently approved october 2012 this injectable drug, jetrea, that is specifically indicated for the condition known as vitreo macular adhesion vma or vitreo macular traction syndrome vmt. Hi i had the jetrea shot to treat a macular hole in my right eye a week ago and a scan performed 3. This may lead to a macular hole, so it is important for you to report all symptoms and any changes in your vision. Boston visual outcomes were similar in eyes with bilateral macular holes that underwent a vitrectomy or intravitreal ocriplasmin injection, but. Member has not received previous treatment with jetrea ocriplasmin in the same eye currently requested. Jetrea ocriplasmin, thrombogenics was approved by the fda in 2012 to treat vitreomacular adhesion. To prepare jetrea for intravitreal injection, adhere to the following instructions. See below for a comprehensive list of adverse effects. Thrombogenics, the manufacturer of ocriplasmin, encountered several. I asked dr s if they had been able to use jetrea with any other patients since i had the injection a month ago. Thrombogenics jetrea shows significant added value to. Jetrea approved in canada for vitreomacular adhesion. Jetrea is the first pharmacological agent to be approved for this indication.
Jetrea ocriplasmin injection, for intravitreal injection, 1. Jetrea ocriplasmin is a truncated form of human plasmin. Asked 20 oct 2014 by ummee1952 updated 31 december 2014 topics. You may also report side effects of jetrea online directly to thrombogenics by clicking here if you are a health care professional. Thrombogenics plays long game for eye disease the motley.
Thrombogenics jetrea receives positive initial nice. Hi i had the jetrea shot to treat a macular hole in my. Ocriplasmin trade name jetrea is a recombinant protease with activity against fibronectin and. Jetrea is specifically indicated for the treatment ofsymptomatic vitreomacular adhesion. Thrombogenics business update fy 2016 markets insider. It works by dissolving the proteins that link the vitreous to the macula, resulting in posterior detachment of the vitreous from. All patients were imaged with spectral domain optical coherence tomography sdoct. Thrombogenics is a proteolytic enzyme administered as a single 0. Thrombogenics jetrea launched in denmark and sweden.
Optimized patient outcomes following jetrea injection may require a thorough clinical evaluation for pertinent baseline findings. You may also report side effects of jetrea online directly to thrombogenics by clicking here if you are a patient or here if you are a health care professional. 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. It is a big breakthough in the the treatment of patients with this. Eight patients with stage 2 macular holes, as defined by. Thrombogenics lead product, jetrea, has been approved by the us food and drug administration for the treatment of symptomatic vitreomacular adhesion. Thrombogenics nv, novartis ag win eu ok for jetrea eye. Alcon, the global leader in eye care and a division of novartis, announces the positive opinion from the committee for medicinal products for human use chmp of the european medicines agency ema for jetrea ocriplasmin, for the treatment of vitreomacular traction vmt, including when associated with macular hole of diameter less than or equal to 400 microns. Is there any treatment for a macular pucker other than. Thrombogenics launched jetrea in the us in midjanuary 20 where it is approved for the treatment of patients with symptomatic vitreomacular adhesion vma. In the controlled trials, the incidence of retinal detachment was 0. Thrombogenics jetrea receives malaysian approval to treat.
Ocriplasmin trade name jetrea is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface. Ocriplasmin jetrea medical clinical policy bulletins aetna. My doctor had mentioned that there was a new medication for it answer. It is used for treatment of symptomatic vitreomacular adhesion, for which it received fda approval on 17 october 2012. The company has built a diverse portfolio of diseasemodifying therapies, including treatments for diabetic eye disease, a leading cause of blindness in people of working age worldwide.
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