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Published on 24 October 2013

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Positive NICE recommendation for Jetrea®

 

 

Alcon, the global leader in eye care, and second largest division of Novartis, is pleased that the National Institute for Health and Care Excellence (NICE) has recommended Jetrea® (ocriplasmin) as a clinically and cost-effective treatment option for eligible patients suffering from vitreomacular traction including when associated with macular hole. 
With this final NICE guidance, Jetrea® is now recommended for use within the National Health Service (NHS) in England and Wales as the first and only pharmacological treatment for this sight-threatening eye condition.
“We are very pleased by the NICE decision, as Jetrea® represents a breakthrough treatment option for patients in the UK, which is now recommended for use in the NHS,” said Stuart Raetzman, Area President Europe, Middle East and Africa, Alcon. “At Alcon, we aim to deliver positive patient outcomes through innovative medicines and medical devices. We work closely with doctors and health care providers to shape the future of eye care and offer solutions to address unmet patient needs.”
Vitreomacular traction and macular hole is an age-related, sight-threatening condition that may lead to visual distortion and central blindness.[1–5] Up to now, the clinical approach for treating vitreomacular traction has been ‘watchful waiting,’ meaning patients undergo a period of observation before they become eligible for eye surgery due to worsening of their condition. Due to the potential risks and complications, surgery is mostly reserved for patients who are heavily impacted by the symptoms of vitreomacular traction.
“People affected by vitreomacular traction can suffer vision changes that have a significant impact on their lives, making it difficult to do everyday activities like reading, watching TV and driving.” said Tim Jackson, Retinal Surgeon at King’s College Hospital. “Until now, eye doctors have only had surgical options to treat this disease, once it progressed to a severe stage. This new treatment is a welcome advance, meaning some patients can now avoid surgery, and others who might not be suitable for surgery can now be treated.”
Jetrea® was approved in March 2013 by the EU Commission for the treatment of vitreomacular traction, in adults, including when associated with macular hole of less than or equal to 400 microns.[6] In the UK, NICE recommended Jetrea® to treat patients suffering from vitreomacular traction, including macular hole of less than or equal to 400 microns when an epiretinal membrane is absent, or adults with vitreomacular traction and severe symptoms, when an epiretinal membrane and macular hole are both absent.[7]
It is delivered as a single, once-only injection into the eye, and studies showed that within 28 days, in approximately one out of four patients, Jetrea® successfully resolved vitreomacular adhesion. In addition, over 40% of patients treated with Jetrea® achieved closure of a macular hole by day 28.[8]
Alcon acquired the rights to commercialise Jetrea® outside the US from the Belgian biopharmaceutical company, ThromboGenics, which retains the rights to commercialise the drug in the US. In October 2012, Jetrea® was licensed in the US for the treatment of patients with symptomatic vitreomacular adhesion.
About vitreomacular traction, including macular hole
As people get older, the vitreous (jelly-like material inside the eye that helps maintain the round shape) detaches naturally from the retina (the light-sensitive layer of tissue located at the back of the eyeball).
However, in some cases, the vitreous remains attached to areas of the retina, particularly at the macula (the area of the retina responsible for central vision needed for everyday tasks such as driving, reading and recognising faces). This is known as vitreomacular adhesion.
If left unresolved, these areas of vitreomacular adhesion can exert a ‘pulling force’ on the macula, a condition known as vitreomacular traction. Vitreomacular traction may eventually lead to the formation of a hole in the macula and is often responsible for progressive, sight-threatening symptoms and irreversible vision loss. Risk factors for vitreomacular traction and macular hole are undetermined, meaning anyone can be affected as they age.[9]
References:
  1. Carpineto P, Di Antonio L, Aharrh-Gnama A, et al. Diagnosing and Treating Vitreomacular Adhesion. Retina 2011 69-73.
  2. Hikichi T, Yoshida A, Trempe C. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1):55-61.
  3. Bottós, Juliana, et al. Vitreomacular Traction Syndrome. Journal of Opthalmalic and Vision Research. 2012;7(2):148-161.
  4. Jaffe NS. Vitreous traction at the posterior pole of the fundus due to alterations in the vitreous posterior. Trans Am Acad Ophthalmol Otolaryngol. 1967;71(4):642-652.
  5. Johnson MW. Perifoveal vitreous detachment and its macular complications. Trans Am Ophthalmol Soc. 2005;103:537-567.
  6. Jetrea® Summary of Product Characteristics. ThromboGenics NV. Belgium; March 2013.
  7. NICE. Ocriplasmin for treating vitreomacular traction. NICE technology appraisal guidance 297. October 2013.
  8. 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.
  9. Steidl S, Hartnett ME. Clinical Pathways In Vitreoretinal Disease 2003;2:212.


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