The Scottish Medicines Consortium (SMC) has accepted German drugmaker Bayer’s (BAYN: DE) Eylea (aflibercept solution for injection) for restricted use within NHS Scotland for the treatment of visual impairment due to diabetic macular edema.
Eligible patients in Scotland will now have access to a further treatment option that has shown to be effective from the start of treatment, without the need for monthly hospital visits (after an initial five monthly loading injections). The recommended dose of Eylea for the treatment of visual impairment due to DME 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.
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 patients treated with Eylea had sustained visual acuity gains compared to patients treated with laser photocoagulation. Results seen in both clinical trials are largely similar in terms of efficacy and tolerability.
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