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NICE Macular Oedema (Branch Retinal Vein Occlusion) Final Technology Appraisal

26 August 2016

Response to NICE announcing their positive final guidance for Eylea® for the treatment of adult patients with visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO)

The Royal College of Ophthalmologists welcomes the Final Appraisal Determination (FAD) from NICE recommending Eylea (aflibercept) as a first-line treatment option for patients with visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO). This recommendation will provide patients with access to an effective treatment option at the time of presentation and is in line with our 2015 Guidelines for Retinal Vein Occlusion which recommend prompt treatment with anti-VEGF agents.

We hope that clinical commissioning groups will support the rapid implementation of the final guidance in order for patients to benefit from anti-VEGF treatment as soon as possible.

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.  Eylea has been shown in a 52-week phase III randomised VIBRANT trial to achieve the target vision gain (≥15 ETDRS[1] letters) in twice as many patients, compared to laser (52.7% vs 26.7%, p=0.0003), in the first 24 weeks of treatment. Patients receiving Eylea also achieved significantly better vision overall than those receiving laser over the same period (mean improvement from baseline best corrected visual acuity at week 24 was 17.0 ETDRS letters in the Eylea group vs 6.9 ETDRS letters in the laser group (p<0.0001)).

The recommended dose for Eylea is 2mg (0.05ml), with treatment given monthly after the initial injection. The interval between two doses should not be shorter than one month. If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, Eylea should be discontinued. Monthly treatment continues until maximum visual acuity is achieved and/or there are no signs of disease activity. Treatment may then be continued to maintain stable visual and/or anatomic outcomes.

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[1] Early Treatment Diabetic Retinopathy Study https://clinicaltrials.gov/ct2/show/NCT00000151