TGA approves ranibizumab for proliferative diabetic retinopathy


Ranibizumab (Lucentis) has become the first drug treatment to be approved in Australia for the treatment of proliferative diabetic retinopathy (PDR).

The Therapeutic Goods Administration (TGA) has approved ranibizumab for the treatment of adults with the eyesight-threatening condition, which is currently treated with panretinal laser photocoagulation (PRP) therapy.

The anti-vascular endothelial growth factor (anti-VEGF) antibody drug is given by intravitreal injection, and according to sponsor Novartis, it has been shown in phase 3 trial to produce >2 step improvement for patients on the diabetic retinopathy severity scale (DRSS) compared to laser therapy.

Around one in five Australians with diabetes have diabetic retinopathy, with one in 24 over the age of 40 experiencing the proliferative form of the disease.

Ranibizumab has been available in Australia for several years as a treatment for other eye conditions such as diabetic macular oedema and aged-related macular degeneration (AMD).

“The TGA approval of [ranibizumab] in treating blindness in patients suffering from diabetes is welcomed by ophthalmologists. Study data shows that [ranibizumab] is effective for improving the severity of retinopathy and treating complications due to proliferative retinopathy in addition to macular oedema”, said Clinical Associate Professor of Sydney University and Vitreoretinal Ophthalmologist and Surgeon, Dr Andrew Chang.

The drug is not listed on the PBS for the condition and according to recent reports could cost a patient up to $7,000 over a year on private prescription.

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