New Treatment to Improve Vision Loss for People With Diabetes

By Novartis Pharmaceuticals Uk Ltd, PRNE
Sunday, January 9, 2011

For UK Media Only

FRIMLEY, England, January 13, 2011 - 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)

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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

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

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


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

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
: 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


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

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