Eylea (aflibercept solution for injection) 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).
EYLEA 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 a five monthly initial loading doses), potentially reducing the burden of treatment for patients already having to manage their diabetes.
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. 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 issue. It 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.
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.
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 2mg of EYLEA, every other month, achieved rapid and sustained visual acuity gains compared to treatment with laser photocoagulation.