– EYLEA® (aflibercept) approved in Australia for the treatment of diabetic macular oedema
(DME) in adults1
– Cootamundra has one of the highest rates of diabetes in the country with 7.6% of people
reported to be living with diabetes2
– Australian research found more than 22% of study participants (49 years plus) with
diabetes developed diabetic eye disease (diabetic retinopathy) within five years

Bayer Australia Ltd today announced the approval by the Therapeutic Goods
Administration (TGA) of EYLEA (aflibercept) for the treatment of diabetic macular oedema (DME)
in adults.

DME may develop from an eye condition called diabetic retinopathy (DR), which is a complication of type 1 and type 2 diabetes4,5 and has been identified to be one of the leading causes of permanent vision loss in working-age people with diabetes.

While there is limited data showing current numbers of people suffering from DME, estimates have been calculated from published data (British Journal of Ophthalmology 2000) and ABS 2012 data suggest that approximately more than 45,000 Australians over 35 years of age may have DME.

The number of people with diabetic eye disease, including DME, may be even higher as Australian prevalence studies have found that there are further undiagnosed people in the population.

Retinal ophthalmologist, Dr Andrew Chang said diabetic patients are at risk of developing some
form of eye disease including diabetic retinopathy. “It is the most common cause of blindness for working-age Australians aged 30-69 years. For these patients, regaining central vision will have broad and real implications to their lives.” “It may mean keeping their job and supporting themselves and their families, holding a driver’s licence and being able to read, watch TV and recognise faces,” Dr Chang said.

The underlying cause of diabetic retinopathy and diabetic macular oedema is damage (caused by abnormal blood glucose levels) to the blood vessels feeding the retina (the lining of light-sensitive cells along the back of the eye). DME occurs when blood vessel leakage affects the macula, the centre of the retina that facilitates pinpoint vision that allows us to read and recognise faces.

Symptoms of DME can include blurred or double vision, the appearance of blind or dark spots,
colours appearing washed-out, distorted lines and, if DME is left untreated, it can eventually lead to severe vision loss and blindness.

“The approval of EYLEA for those living with DME provides treating doctors with another tool to
combat vision loss in their patients which is so important in supporting our aim of helping these
Australians maintain their independence”, said Dr Chang.

EYLEA works by blocking the triggers (known as VEGF receptors) believed to be involved in the
growth of these abnormal, leaky blood vessels in the retina. Treatment involves one injection per month for the first five consecutive months, followed by one injection every two months. After the first 12 months, the treatment interval may be extended based on visual and anatomic outcomes.

“It is important that Australians with diabetes who are concerned about their sight or have suspected DME discuss the appropriate testing and treatment approach with their ophthalmologist,” Dr Chang added.

Following the approval by the TGA, Bayer is working with the Government to secure timely
reimbursement and listing on the Pharmaceutical Benefit Scheme (PBS) for EYLEA in DME.
In addition to the Australian registration, EYLEA is also approved for treatment of DME in the US, Canada, EU and Japan.

TGA approved indications

EYLEA (aflibercept) is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (wet AMD), visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) and diabetic macular oedema (DME).

Consumer Medicine Information (CMI)

For further information about EYLEA please speak with a healthcare professional and access the full Consumer Medicine Information (CMI) available at: http://bayer.com.au/scripts/pages/en/bayerrsquos_products/index.php aktion=details&id=642&l1=
&l2=