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Response to NICE announcing their positive draft final guidance for EYLEA® for the treatment of visual impairment due to diabetic macular oedema (DMO)

2 June 2015

The Royal College of Ophthalmologists welcomes the draft Final Appraisal Determination (FAD) from NICE recommending EYLEA (aflibercept) as a treatment option for patients with visual impairment due to diabetic macular oedema (DMO) and a central retinal thickness of >400 micrometers. We hope that this decision will become final and that clinical commissioning groups will support the rapid implementation of the final guidance so patients can benefit from a further treatment option for this potentially debilitating condition.

EYLEA is a soluble human fusion protein which binds to vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF), tighter than their natural receptors do, in order to inhibit their action. This drug has been shown in two licensing trials, VIVID-DME and VISTA-DME, to deliver sustained visual acuity gains compared to laser photocoagulation after two years of EYLEA 2 mg every other month, following five initial monthly injections (VIVID-DME: mean gain from baseline for BCVA was 9.4 letters with EYLEA and 0.7 letters with laser photocoagulation. VISTA-DME: mean gain from baseline for BCVA was 11.1 letters with EYLEA and 0.9 letters with laser photocoagulation).

The recommended dose for EYLEA is 2mg (0.05ml) administered by intravitreal injection monthly for five months at the start of treatment, followed by one injection every two months without the need to visit the hospital for monitoring between injections. After the first 12 months of treatment with EYLEA, the treatment interval may be extended based on visual and / or anatomic outcomes. The schedule for monitoring should be determined by the treating physician.

 

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