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In a Final Appraisal Determination (FAD) published October 25, The National Institute for Health and Care Excellence (NICE) has recommended that Lucentis® (ranibizumab) be approved for use within the NHS in England and Wales as an option to treat people with visual impairment due to choroidal neovascularisation associated with pathological myopia (myopic CNV)6.
Myopic CNV is the growth of abnormal leaky blood vessels in the back of the eye in high myopia (severe near sightedness). Without treatment, myopic CNV has a poor long-term prognosis, with approximately 90 percent of affected patients developing severe vision loss after five years1,2,7. Ranibizumab is the first licensed treatment which has been shown to improve vision in those with the condition4,5. The decision by NICE to move straight to a positive FAD will mean earlier access to ranibizumab for an estimated 2,000 people in the UK each year who develop visual impairment associated with myopic CNV8,9,10.
Patient groups and the clinical community will welcome today's recommendation. Until now people with myopic CNV have had to face the possibility of irreversible sight loss because available licensed treatment has been limited to verteporfin photodynamic therapy (vPDT) (Visudyne®), which at best can stabilise but not improve vision and is not widely used in the NHS5,6. In evidence presented to the NICE Committee, both patient and clinical representatives outlined the urgent need for effective treatment of myopic CNV and the distress that delays in accessing sight saving treatment can have on this group of patients and their families11.
Mr Adnan Tufail, Consultant Ophthalmologist at Moorfields Eye Hospital comments: "The decision by NICE to recommend ranibizumab for the treatment of myopic CNV is great news for people with this condition. Myopic CNV usually affects people under the age of 50, who are likely to be working and have families, so the loss of vision can have an enormous impact, affecting their ability to work and do everyday things such as drive or read. Being able to offer patients access to ranibizumab will make a significant difference to the treatment outcomes we can achieve. As the clinical trials have shown, ranibizumab can restore vision rapidly in some patients and importantly with just a few injections."
In the RADIANCE clinical trial, ranibizumab demonstrated superior improvement in visual acuity compared with vPDT in patients with myopic CNV12,13. These data showed around 40 percent of ranibizumab treated patients compared with 15 percent of vPDT treated patients gained 15 or more letters of visual acuity at month three14. Mean visual acuity gains of approximately 14 letters at one year were demonstrated, when patients received one initial injection of ranibizumab (0.5 mg) on day one and were then treated with a flexible dosing regimen at month one based on disease activity; this was with a median of 2.5 injections12,14.
Novartis looks forward to the publication of the institute's final Technology Appraisal Guidance (TAG) on ranibizumab for the treatment of visual impairment due to myopic CNV, which is expected in November.
About myopic CNV
Myopic choroidal neovascularisation (myopic CNV) is the most common vision-threatening macular complication observed in pathological myopia (PM)5,15. Myopic CNV is characterised by an excessive elongation of the eyeball associated with degenerative changes of the light-sensitive tissue and the formation of abnormal blood vessels. These vessels originate from the choroid layer of the eye and may leak or bleed into the retina, which can result in irreversible deterioration of central vision1-3.
About Lucentis® (ranibizumab)
Ranibizumab is an anti-VEGF also licensed for the treatment of visual impairment due to macular oedema secondary to Retinal Vein Occlusion (RVO) (central and branch), visual impairment due to Diabetic Macular Oedema (VI-DMO) and wet Age-related Macular Degeneration (AMD). It is approved by NICE and the SMC for eligible patients across these indications16,17,18,19,20,21.
In these indications ranibizumab is injected according to individual need, so patients can gain and maintain vision, while reducing the risk associated with over or under treatment. This flexible treatment regimen means that once vision is stable, treatment with ranibizumab can be stopped. In RVO and VI-DMO if there is no improvement in visual acuity over the course of the first three injections, continued treatment is not recommended. Patients are then monitored monthly to detect any loss of visual acuity, with retreatment initiated if vision becomes unstable4.
Patients with myopic CNV receive one injection, with any further injections administered as required. Retreatment is based on vision and anatomical changes and monitoring is required monthly for the first two months and then at least quarterly up to one year; in the second year monitoring is at the discretion of the treating physician4.
The safety profile of ranibizumab is well-characterised with over 2 million patient-treatment years of exposure and a clinical development programme which has enrolled more than 15,000 patients across all its indications22,23.
Ranibizumab was developed by Genentech and Novartis. Genentech has the commercial rights in the US, while Novartis has exclusive rights in the rest of the world.
 RNIB, Myopia and high degree Myopia: http://www.rnib.org.uk/eyehealth/eyeconditions/eyeconditionsdn/Pages/high_degree_myopia.aspx. Accessed September 2013
 Chan WM, Ohji M, Lai TY, Liu DT, Tano Y, Lam DS. Br J Ophthalmol 2005;89(11):1522-1528
 Tong JP, Yao YF. Clin Biochem 2006;39(3):267-276
 Lucentis SmPC: http://www.medicines.org.uk/emc/medicine/19409/SPC/Lucentis+10+mg+ml+solution+for+injection Accessed October 2013
 Neelam K, et al. Progress in Retinal Eye Research. 2012.
 NICE Final appraisal determination. Ranibizumab for treating choroidal neovascularisation associated with pathological myopia. October 2013
 Yoshida T et al. Ophthalmology 2003;110:1297-1305
 Vongphanit J, Mitchell P, Wang JJ. Ophthalmology 2002;109:704-11.
 Hampton GR, Kohen D, Bird AC. Ophthalmology 1983;90:923-6.
 Ohno-Matsui K, Yoshida T, Futagami S et al. Br J Ophthalmol 2003;87:570-3.
 Choroidal neovascularisation (pathological myopia) - ranibizumab: response to comments on the draft scope and provisional matrix: http://guidance.nice.org.uk/TAG/336/ResponseCCCommentsDraftScopeProvisionalMatrix/pdf/English. Accessed October 2013
 Bandello F. Twelve-month efficacy and safety of ranibizumab 0.5 mg versus verteporfin photodynamic therapy in the treatment of visual impairment due to choroidal neovascularization secondary to pathologic myopia. Association for Research in Vision and Ophthalmology 2013
 Novartis Data on File – LUCDOF13-009
 Novartis data on file – LUCDOF 13-010
 NICE, 2012, available online: http://www.nice.org.uk/nicemedia/live/14019/63645/63645.pdf accessed July 2013
 NICE TA274 Ranibizumab for treating diabetic macular oedema (rapid review of technology appraisal guidance 237). Available athttp://publications.nice.org.uk/ranibizumab-for-treating-diabetic-macular-oedema-rapid-review-of-technology-appraisal-guidance-ta274. Accessed July 2013
 NICE TA283. Ranibizumab for treating visual impairment caused by macular oedema secondary to retinal vein occlusion. Available at http://guidance.nice.org.uk/TA283. Accessed July 2013
 SMC. Ranibizumab (Lucentis) Novartis Pharmaceuticals UK Ltd SMC No. (381/07) – May 2007
 SMC. Ranibizumab (Lucentis) Novartis Pharmaceuticals UK Ltd SMC No. (711/11) – November 2012
 SMC. Ranibizumab (Lucentis) Novartis Pharmaceuticals UK Ltd SMC No. (732/11) – April 2013
 NICE TA155 Macular degeneration (age-related) - ranibizumab and pegaptanib: guidance. Available at http://guidance.nice.org.uk/TA155/Guidance/pdf/English. Accessed July 2013
 Novartis Data on File – LUCDOF13-006
 Novartis Data on File – LUCDOF13-014
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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