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News

 18th January 2011
Novartis

New Treatment to Improve Vision Loss for People With Diabetes

FRIMLEY, England

First Licensed Treatment in 25 Years(1) for Diabetic Macular Oedema, One of the Leading Causes of Visual Impairment in the UK Working Population(2) Launched Today

Novartis Pharmaceuticals UK Ltd today announced that Lucentis(R) (ranibizumab) is being launched in the UK for the treatment of visual impairment due to diabetes, specifically diabetic macular oedema (DMO). This offers fresh hope for people with this serious and common complication of diabetes. Ranibizumab is the first licensed therapy to improve vision and vision-related quality of life in people with visual impairment due to DMO.(3)

For people with diabetes, visual impairment is one of the most feared complications of the condition(4) and is often caused by DMO. People with visual impairment due to DMO are less able to live and work independently. Until now, laser treatment has been the standard treatment, offering stabilisation of vision loss but no significant improvement. In some people with diabetes who are experiencing visual impairment, ranibizumab can offer rapid and sustained vision gains compared to laser alone. The visual improvements of at least two additional lines on an eye chart could make an extraordinary difference to the person's quality of life and independence.(2)

DMO affects 5-10% of people with diabetes, and in many it will cause visual impairment.(5) Visual loss due to DMO occurs in around 50,000 people in the UK.(6,7) Diabetes is a condition in which blood glucose levels are above normal and is known to cause serious health complications, including heart disease, stroke, blindness, kidney failure, and lower-extremity amputations.(7)

Simon O'Neill, Director of Care, Information and Advocacy at Diabetes UK commented on the importance of good eye health for those with diabetes "DMO is one of many serious and common complications of diabetes, therefore it is important that people with diabetes undergo annual eye tests, including a retinal photograph, and have a greater awareness of their eye health, so that they can immediately respond to any changes in their vision."

If DMO is left untreated, there is a 25-30% risk of developing clinically significant macular oedema, leading to vision loss.(8) Moderate visual loss will occur in approximately 24% of untreated eyes where clinically significant macular oedema has developed.(8) Furthermore, even with current treatment, 12% of eyes develop moderate visual loss after 3 years.(1)

Mr. Nicholas Beare, Consultant Ophthalmologist, Royal Liverpool University Hospital, who led clinical research investigating the use of ranibizumab for treating DMO, explains what this new option means for the future of treating this condition "Ranibizumab has the potential to transform treatment for people with diabetic macular oedema in the UK. For the last 25 years, laser therapy has been the standard treatment for DMO but it is not generally associated with visual improvement, whereas ranibizumab has been shown to produce a rapid and sustained improvement in vision."

The safety profile of ranibizumab in DMO is comparable to that seen in previous studies for Age-related Macular Degeneration (AMD), adding further weight to its established safety profile, shown through the robust ranibizumab clinical trial programme.(9,10,11)

About ranibizumab Ranibizumab has been approved in the UK and more than 80(12) countries for the intraocular treatment of wet age-related macular degeneration (AMD) under the brand name Lucentis(R). Ranibizumab is the only NICE approved treatment for wet AMD and received EMA approval for the treatment of DMO with visual impairment on January 07, 2011. 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.

About DMO Diabetic macular oedema (DMO) is a consequence of diabetic retinopathy, the most common diabetic eye complication, and is characterised by changes in the blood vessels of the retina, the light-sensitive layer at the back of the eye. In people with DMO, leakage from these abnormal blood vessels occurs in the central portion of the retina, called the macula. Because this part of the eye is responsible for sharp central vision, DMO can lead to significant visual impairment. DMO affects 5-10%,(5) and with visual impairment approximately 1-3%(13) of people with diabetes,(6,7) and DMO is a leading cause of blindness in the working-age population in most developed countries.(2)

About Novartis Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group's continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100.000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

About Diabetes UK Diabetes UK is the leading charity for over 3.5 million people in the UK with diabetes, funding research, campaigning and helping people living with the condition. Our mission is to improve the lives of people with diabetes and work towards a future without diabetes. All of this and more is only made possible through donations and by people supporting Diabetes UK. For more information visit http://www.diabetes.org.uk.

References

1. Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol. 1985 Dec;103(12 ):1796-806.

2. Cuilla TA et al. Diabetes Care 2003; 26:2653-2664

3. Data on file. Novartis Pharmaceuticals UK Ltd LUCDOF10 -008 - RESTORE 12 month data

4. Davidov E et al. Graefes Arch Clin Exp Ophthalmol 2009;247:267-272

5. Chen et al 2010 Curr Med Res Opin 2010; 26: 1587-97

6. Data on file. Novartis Pharmaceuticals UK Ltd. Advanced notification and planning information for NHS decision makers and policy holders, July 2009: ranibizumab (Ranibizumab)

7. Diabetes UK. Diabetes in the UK 2010: Key statistics on diabetes. 2010

8. National Institute for Health and Clinical Excellence. Draft scope for the proposed appraisal of ranibizumab for the treatment of diabetic macular oedema, 2010.

9. Rosenfeld PJ et al. N Engl J Med 2006;355:1419-1431

10. Brown DM et al. Ophthalmology 2009;116:57-65

11. Regillo CD et al. Am J Ophthalmol 2008;145:239-248

12. Data on file. Novartis Pharmaceuticals UK Ltd LUCDOF10-014

13. Data on file. Novartis Pharmaceuticals UK Ltd LUCDOF 10-009

Video: http://multivu.prnewswire.com/mnr/prne/novartis/47579/

Source: Novartis Pharmaceuticals UK Ltd

Novartis UK Press Office: +44-(0)1276-698691, pressoffice-uk.phgbfr@novartis.com. Michelle Sykes, Weber Shandwick, +44-(0)207-067-0237, msykes@webershandwick.com


 

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