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Alcon, the global leader in eye care, is pleased that the National Institute for Health and Care Excellence (NICE) Appraisal Committee has delivered a positive Final Appraisal Determination (FAD) for Jetrea®, recommending its use to treat adults with 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.
The Jetrea FAD follows the initial positive NICE recommendation (ACD) in June and is the last step in the process before final guidance is issued. Provided the final NICE guidance, expected by autumn, confirms these recommendations, Jetrea will be approved for National Health Service (NHS) patients in England and Wales.
Mr Tim Jackson, Consultant Retinal Surgeon at King's College Hospital, said, "People affected by vitreomacular traction or macular hole suffer vision changes that can have a significant impact on their life, making it difficult to read, watch TV, drive, or keep their jobs in some cases. For suitable patients, the injection offers a treatment that may avoid the need for eye surgery, and means those unsuited to surgery can now be treated, often before their condition deteriorates. Today's decision is an important step forward in increasing the treatment options for patients and eye doctors."
Vitreomacular traction and macular hole are age-related, sight-threatening conditions that can cause blind spots, visual distortion and reduced visual acuity. If left untreated it may progressively lead to irreversible visual distortion, loss in visual acuity and central blindness.,,,,
Alcon is committed to working with NICE and the NHS to support the implementation of Final Guidance to deliver real benefits to patients who currently have no pharmaceutical treatment option.
Up to now, the clinical approach for vitreomacular traction patients has been 'watchful waiting', meaning patients must undergo a period of observation before they become eligible for eye surgery. Due to the potential risks and complications, surgery is mostly reserved for patients who are heavily impacted by the symptoms of vitreomacular traction; these patients are usually in the later stage of the disease, often with macular hole, so lost vision may not be fully recovered.
Jetrea® was licensed 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. 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.
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.
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. 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. Vitreomacular traction is often responsible for progressive sight-threatening symptoms and irreversible vision loss.
 Carpineto P,Di Antonio L,Aharrh-Gnama A et al. Diagnosing and Treating Vitreomacular Adhesion. Retina 2011 69-73
 Hikichi T, Yoshida A, Trempe C. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1):55-61
 Bottós, Juliana, et al. Vitreomacular Traction Syndrome. Journal of Opthalmalic and Vision Research. 2012;7(2):148-161
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 Jetrea® Summary of Product Characteristics. ThromboGenics NV. Belgium; March 2013
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Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Alcon. "Alcon receives positive recommendation from NICE Appraisal Committee for use of Jetrea® in patients with vitreomacular traction and macular hole." Medical News Today. MediLexicon, Intl., 30 Aug. 2013. Web.
12 Dec. 2013. <http://www.medicalnewstoday.com/releases/265430>
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