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Wednesday / June 19.
HomeminewsEylea Approved for Diabetic Macular Edema

Eylea Approved for Diabetic Macular Edema

Eylea (aflibercept) has been included on the Pharmaceutical Benefits Scheme (PBS) for the treatment of Australian adults living with Diabetic Macular Edema (DME) from 1 October 2015.

DME is estimated to affect 72,000 Australians in 2015.1 Everyone living with type 1 or type 2 diabetes is at risk of developing diabetic eye disease, including DME.2,3 It is caused by chronic high blood sugar levels secondary to the condition2,4 and occurs when fluid leaks into the macula. If left untreated, DME can impact visual acuity and ultimately lead to severe vision loss and blindness.

Data from Phase 3 trials (VIVID-DME and VISTA-DME) show that DME patients treated with Eylea gained, on average, one line in best-corrected visual acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, after the first injection and the ability to read approximately two additional lines of letters within the first year.4 One third of patients gained three lines within the first year (range 31.1 per cent–41.6 per cent, p<0.0001)4 and importantly, results were maintained at 100 weeks.5 Treatment involves one intravitreal injection per month for the first five consecutive months, followed by one injection every two months. After the first twelve months, the treatment interval may be extended based on visual and anatomic outcomes.5

“Losing just one line of visual acuity can mean losing your job, your driver’s licence and your ability to maintain your independence”, said Professor Paul Mitchell, Head of Ophthalmology at Sydney’s Westmead Hospital. “The PBS listing of Eylea is an important additional therapy option for ophthalmologists and their patients. This means we have another tool available to address this serious, and in many cases, life-changing complication associated
with diabetes.”

Losing just one line of visual acuity can mean losing your job, your driver’s licence and your ability to maintain your independence

DME is one of the leading causes of blindness in working-age adults in most developed countries,3 and the number of people living with the condition is predicted to increase by 42 per cent to 102,000 over the next 15 years due to the expected increase in diabetes prevalence.1

“The impact DME has on the individual and the community is the reason that early detection and treatment of DME is so important to prevent or delay vision loss,“ said Professor Mitchell. “GPs, diabetes educators and optometrists play an invaluable role in supporting people living with diabetes to have their regular, bi-annual eye checks and if necessary receive timely treatment to save their sight.”

Eylea is also available on the PBS for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) from 1 October 2015. CRVO is caused by an obstruction of the central retinal vein, which can cause vision loss due to blood and fluid leaking into the retina. Treatment is initiated with one injection per month for three consecutive months. After the first three montly injections, the treatment interval may be extended based on visual and anatomic outcomes.5

Eylea is already PBS listed for the treatment of neovascular (wet) age-related macular degeneration (wetAMD).

References:

1. Deloitte Access Economics Pty Ltd, 2015, The Economic Impact of Diabetic Macular Oedema in Australia.

2. The Angiogenesis Foundation, 2014, A Patient Guide to Diabetes Macular Edema.

3. Ciulla TA, Amador AG, Zinman B, 2003, Diabetic Retinopathy and Diabetic Macular Edema: Pathophysiology, Screening, and Novel Therapies, Diabetes Care 26(9): 2653-64.

4. Korobelnik, Jean-Francios et. al. Intravitreal Aflibercept for Diabetic Macular Edema. Opthalmology. 2014.

5. EYLEA Product Information April 2015.