NICE recommends aflibercept and dexamethasone as possible treatment options for diabetic macular oedema

The National Institute for Health and Care Excellence (NICE) has recommended aflibercept solution for injection (Eylea, Bayer Pharma), and dexamethasone intravitreal implant (Ozurdex, Allergan) as possible treatment options for some people with diabetic macular oedema.

Diabetic macular oedema is a common complication associated with diabetic retinopathy, and is the most common cause of visual impairment in people with diabetes. It develops when blood vessels in the eye are damaged by a continuously high blood sugar level, causing plasma to leak into the eye. Abnormal new blood vessels also form under the retina. This causes a build-up of excess fluid (oedema) in the macular, which is the central part of the retina. The oedema impairs light perception, causing blurred vision. If it is not treated effectively, it can lead to irreversible vision loss.

Aflibercept helps treat swelling in the retina caused by oedema

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It prevents abnormal new blood vessels from forming under the retina. It also helps treat swelling in the retina caused by oedema.

The final draft guidance recommends aflibercept solution for injection as a treatment option in people only if:

• the eye has a central retinal thickness of 400 micrometres or more at the start of treatment, and
• the company provides aflibercept with the discount agreed in the patient access scheme.

Dexamethasone inhibits the release of inflammatory compounds that cause damage to the eye

Dexamethasone works by suppressing inflammation and preventing oedema forming in the eye. It reduces plasma leakage from blood vessels and inhibits the release of inflammatory compounds that cause damage to the eye.

In the second piece of final draft guidance, dexamethasone intravitreal implant is recommended as a treatment option in people only if:

• the implant is to be used in an eye with an intraocular (pseudophakic) lens, and
• their diabetic macular oedema does not respond to non-corticosteroid treatment or such treatment is unsuitable.

The dexamethasone intravitreal implant is injected into the eye, with each implant delivering around 700 micrograms of dexamethasone to the back of the eye over a period of 6 months or more. The implant remains in the vitreous for up to 270 days before fully dissolving. Re-treatment can be performed after approximately 6 months if the patient experiences decreased vision with or without an increase in retinal thickness with recurrent or worsening diabetic macular oedema.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said, “NICE is pleased to give the green light to both dexamethasone intravitreal implant and aflibercept as treatment options for some people with diabetic macular oedema in final draft guidance. The condition affects around 189,000 people with diabetes in the UK, and can have a substantial negative impact on quality of life and daily activities. These decisions will therefore be welcome news to both patients and healthcare professionals alike.”