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Published on 12 August 2014

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EYLEA® receives third licence in Europe

 

 

Bayer HealthCare has announced that EYLEA® (aflibercept solution for injection) has been approved by the European Commission for the treatment of visual impairment due to diabetic macular oedema (DMO).(1) 
EYLEA is an established treatment for other eye conditions that could now offer patients with DMO significant visual benefits, from start of treatment, without the need for strict monthly hospital visits (after an initial five monthly loading doses); potentially reducing the burden of treatment for patients already having to manage their diabetes.(2,3)
Bayer plans to launch EYLEA in the UK for this indication in the coming months; with guidance from the Scottish Medicines Consortium (SMC) and the National Institute for Health and Care Excellence (NICE) expected in November 2014 and June 2015, respectively.
Dr Sobha Sivaprasad, Consultant Ophthalmologist, Moorfields Eye Hospital and King’s College Hospital London said, “It is good news for patients and ophthalmologists that we now have a further treatment option available for visual impairment due to DMO. Eylea has shown impressive results in clinical trials, with significant visual gains, meaning it has the potential to save people’s sight.”
The recommended dose of EYLEA for the treatment of DMO is 2mg. Treatment is initiated with one injection per month for five consecutive doses, followed by one injection every two 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.(2)
The submission to the European Commission for the EYLEA DMO indication was based on data from the positive Phase III VIVID-DME and VISTA-DME studies which showed that EYLEA is capable of delivering sustained visual acuity gains compared to laser photocoagulation.(3)
In the VIVID-DME study, after Week 52, patients receiving EYLEA 2mg every other month (after 5 initial monthly injections) had a mean gain from baseline in best corrected visual acuity (BCVA) of +10.(7) letters (p<0.0001). This is equivalent to a gain of more than two lines on the Early Treatment Diabetic Retinopathy Scale (ETDRS) (eye chart to assess visual acuity). Patients receiving laser photocoagulation had a mean change from baseline in BCVA of +1.2 letters.(3)
In the VISTA-DME study, after Week 52, patients receiving EYLEA 2 mg every other month (after 5 initial monthly injections) had a mean gain from baseline in BCVA of +10.7 letters (p<0.0001), compared to patients receiving laser photocoagulation who had a mean change from baseline in BCVA of +0.2 letters. Further secondary endpoints in the VIVD-DME and VISTA-DME studies included the change from baseline in central retinal thickness, diabetic retinopathy severity score and vision related quality of life.(3)
In both studies, EYLEA was well tolerated with a similar overall incidence of adverse events (AEs), serious ocular AEs, and serious non-ocular AEs across the treatment groups and the laser control group.(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 SMC for use within NHS Scotland for the treatment of wAMD in April 2013.(4) It was recommended by 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.(5)
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.(6) NICE recommended EYLEA for this indication in February 2014 for use in England and Wales,(7) with the SMC accepting EYLEA for use within NHS Scotland for this indication in April 2014.(8)
References
  1. EC decision date of approval 6th August 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 accessed: July 2014)
  4. Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®) SMC No. (857/13). Available at: http://www.scottishmedicines.org.uk (Last accessed: July 2014)
  5. National Institute for Health and Care Excellence. Technology Appraisal 294. Aflibercept solution for injection for treating wet age related macular degeneration. July 2013
  6. European Medicines Agency. Eylea (Aflibercept). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_and_scientific_information_after_authorisation/human/002392/WC500148632.pdf (Last accessed: July 2014)
  7. 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
  8. Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®). April 2014. Available at: http://www.scottishmedicines.org.uk


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