Novartis Pharmaceuticals UK Ltd announced that Lucentis® (ranibizumab) has 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. Until now, laser treatment has been the current standard treatment but has not been shown to improve vision. Ranibizumab not only offers stabilisation of vision loss but can also lead to significant improvements in vision. It is the first licensed therapy to improve vision and vision-related quality of life in people with visual impairment due to diabetic macular oedema.3
Approval for this new indication for ranibizumab was based on data from two pivotal randomised Phase III trials, which demonstrated ranibizumab provided rapid, superior and sustained vision gains compared to the current standard of treatment.3,4 Data from the RESTORE Phase III study (354 eyes), show that ranibizumab is significantly more effective at treating visual impairment due to DMO, compared to laser treatment.3 At one year, the RESTORE results show that on average 37% of people treated with ranibizumab 0.5 mg alone, and 43% of those treated with ranibizumab plus laser therapy, gained a substantial vision improvement of 10 letters or more on an eye-chart, versus 16% of people treated with laser alone.3 In addition, ranibizumab was shown in the RESTORE Phase III study to provide a significant improvement in quality of life.3
The safety profile of ranibizumab in RESTORE is consistent with that previously observed in large controlled clinical trials for wet age-related macular degeneration (wet AMD), with no new safety risks observed. These efficacy and safety data support the earlier results of the pivotal RESOLVE study comparing ranibizumab to sham treatment.4
Mr. Nicholas Beare, Consultant Ophthalmologist, Royal Liverpool University Hospital, UK investigator in the RESTORE trial, explains what this new option means for the future of treating this condition “It is great news for both clinicians and people with diabetes alike that ranibizumab is now available to treat DMO in the UK. Ranibizumab has the potential to transform the way we treat DMO in the UK. For the last 25 years, laser therapy has been the standard of care in DMO but it is not generally associated with visual improvement, whereas ranibizumab has been shown to produce a rapid and sustained improvement in vision.”
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 For people with diabetes, visual impairment is one of the most feared complications of the condition8 and is most often caused by DMO. People with visual impairment due to DMO are less able to live and work independently.
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
Ranibizumab is currently licensed and marketed for wet AMD in more than 8010 countries, and it benefits from continuous safety monitoring through systematic pharmacovigilance.
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.11, 12, 13
Ranibizumab has been approved in the UK and more than 8010 countries for the intraocular treatment of wet age-related macular degeneration (AMD) under the brand name Lucentis®. 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.
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%14 of people with diabetes,6,7 and DMO is a leading cause of blindness in the working-age population in most developed countries.
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. Data on file. Novartis Pharmaceuticals UK Ltd. LUCDOF-007- RESOLVE study
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. Davidov E et al. Graefes Arch Clin Exp Ophthalmol 2009;247:267-272
9. National Institute for Health and Clinical Excellence. Draft scope for the proposed appraisal of ranibizumab for the treatment of diabetic macular oedema, 2010.
10. Data on file. Novartis Pharmaceuticals UK Ltd LUCDOF10-014
11. Rosenfeld PJ et al. N Engl J Med 2006;355:1419-1431
12. Brown DM et al. Ophthalmology 2009;116:57-65
13. Regillo CD et al. Am J Ophthalmol 2008;145:239-248
14. Data on file. Novartis Pharmaceuticals UK Ltd. LUCDOF10-009
View drug information on Lucentis.