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Published on 3 July 2014

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EYLEA recommended for approval

Bayer HealthCare has announced that EYLEA has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular oedema (DMO).(1)

Bayer HealthCare has announced that EYLEA has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular oedema (DMO).(1)

The final decision of the European Commission is expected in the coming months. EYLEA (aflibercept solution for injection) is an established treatment for other eye conditions that could offer patients with DMO significant visual benefits, from start of treatment, without the need for strict monthly hospital visits (after five monthly initial loading doses), potentially reducing the burden of treatment for patients already having to manage their diabetes.(2,3)

Dr Sobha Sivaprasad, Consultant Ophthalmologist, Moorfields Eye Hospital and King’s College Hospital London said, “Early diagnosis and effective treatment of visual impairment due to DMO is paramount to ensure sight is saved, so having another treatment option available that has shown significant visual gains will be good news for patients and ophthalmologists.”

DMO, a serious eye condition affecting people with diabetes, is the commonest cause of blindness among people of working age in the developed world.(4) The number of people with DMO is set to increase significantly with the expected growth of the diabetes population, adding to what is already a major public health concern.(5)

DMO is caused by a complication of diabetes – diabetic retinopathy. Clinically significant DMO occurs when fluid leaks from damaged blood vessels beneath the macula, the part of the retina responsible for central vision. Fluid beneath the macula can cause severe sight loss or blindness.(6)

The recommended dose of EYLEA for the treatment of DMO is 2 mg. Treatment is initiated with one injection per month for five consecutive doses, followed by one injection every 2 months without any requirement for monitoring between injections. After the first 12 months of treatment, the treatment interval may be extended based on visual and anatomic outcomes.(1)

The submission to the European Commission for the EYLEA DMO indication is based on data from the positive phase III VIVID-DME and VISTA-DME studies which showed 2 mg of EYLEA, every other month, achieved rapid and sustained visual acuity gains compared with treatment with laser photocoagulation.(3)

EYLEA has been licensed in the UK for the treatment of wet age related macular degeneration (wAMD) since November 2012.(2) EYLEA was accepted by the Scottish Medicines Consortium (SMC) for use within NHS Scotland for the treatment of wAMD in April 2013.(7) It was recommended by National Institute for Care and Excellence (NICE) for this use on the NHS in England and Wales in July 2013 and availability to eligible wAMD patients is now mandated across England and Wales.(8)

EYLEA was licensed in the UK for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) in August 2013.(2) The NICE recommended EYLEA for this indication in February 2014 for use in England and Wales,(9) with the SMC accepting EYLEA for use within NHS Scotland for this indication in April 2014.(10)

Regulatory submissions have been made in Japan, Asia Pacific, Latin America and the U.S., for the treatment of DMO. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularisation secondary to pathologic myopia (mCNV). Furthermore, a regulatory submission has been made in Europe and the U.S. for EYLEA for the treatment of visual impairment due to macular oedema following branch retinal vein occlusion.

References

  1. European Medicines Agency. Committee for Medical Products for Human Use. Summary of opinion. Eylea for the treatment of visual impairment due to diabetic macular oedema (DMO). June 2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002392/WC500169306.pdf (Last accessed June 2014).
  2. Eylea® (VEGF Trap-Eye) summary of product characteristics (SmPC).
  3. U.Schmidt-Erfurth. Efficacy and Safety of Intravitreal aflibercept in DME: Results of two phase III studies (VIVID-DME and VISTA-DME). Free Paper Session: New drug treatment and technology. EURETINA 13th Congress. September 2013. Available at: http://www.euretina.org/hamburg2013/programme/free-papers-details.asp?id=2732&day=0 (Last asscessed: June 2014).
  4. Romero-Aroca P, Managing diabetic macular edema: The leading cause of diabetes blindness. World J Diabetes. 2011 2(6):98–104
  5. Help Diabetes, National Institute for Health Research, Rising obesity causes number of diabetes to double in 20 years. Available at: http://www.researchforthefuture.org/2013/09/rising-obesity-causes-number-of-diabetes-cases-to-double-in-20-years/ (Last accessed: June 2014).
  6. Macular Society. Diabetic macular oedema. Available at: http://www.macularsociety.org/about-macular-conditions/Other-macular-conditions/Diabetic-macular-oedema (Last accessed: June 2014).
  7. Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®) SMC No. (857/13). Available at: http://www.scottishmedicines.org.uk (Last accessed March 2014).
  8. National Institute for Health and Care Excellence. Technology Appraisal 294. Aflibercept solution for injection for treating wet age related macular degeneration. July 2013.
  9. National Institute for Health and Care Excellence. Final Appraisal Determination. Aflibercept for treating visual impairment caused by macular oedema secondary to central retinal vein occlusion. February 2014.
  10. Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®). April 2014. Available at: http://www.scottishmedicines.org.uk  (Last accessed March 2014).


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