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TGA approves first pharma option for proliferative diabetic retinopathy

For 40 years laser therapy has been the standard treatment for proliferative diabetic retinopathy (PDR), but now Australian ophthalmologists have a new option following regulatory approval of an existing drug.

Novartis has announced the Therapeutic Goods Administration approval of Lucentis (ranibizumab) for treating PDR in adults. It is the first pharmacological therapy in Australia for the vision-threatening complication of diabetes – and the sixth indication for Lucentis.

Until now, panretinal laser photocoagulation (PRP) has been the standard treatment for PDR but can result in permanent side effects, and negatively impact peripheral vision, affecting the ability to carry out daily activities, such as driving.

Regulatory approval of Lucentis was based on findings from a multicentre, randomised, active-controlled, parallel-assignment, non-inferiority phase 3 study in which 305 patients with PDR, with or without diabetic macular oedema (DME) at baseline, were enrolled. The study compared ranibizumab 0.5 mg intravitreal injections to standard treatment with PRP.

The findings were supported by pooled data from three key Novartis studies demonstrating that Lucentis led to an improvement in the diabetic retinopathy severity scale (DRSS).

Analysis of results at two years, with an additional follow-up with 66% of study participants at five years, favoured Lucentis over laser treatment and indicated a potential to prevent PDR disease progression.

Clinical Associate Professor of Sydney University and vitreoretinal ophthalmologist and surgeon, Dr Andrew Chang, said ophthalmologists welcome the TGA approval of Lucentis in treating blindness in patients suffering from diabetes.

“Study data shows that Lucentis is effective for improving the severity of retinopathy and treating complications due to proliferative retinopathy in addition to macular oedema,” he said.

Statistics show diabetic retinopathy (DR) is one of the top five causes of irreversible blindness among Australian adults and the leading cause of blindness amongst working age adults worldwide.

In can worsen over time from the non-proliferative form (NPDR) to the vision-threatening form, PDR. Without treatment, approximately 50% of people with very severe NPDR progress to PDR within a year and 25% of people who have had diabetes for 15 years will have PDR.

Macular Disease Foundation Australia (MDFA) CEO Ms Dee Hopkins welcomed the new indication for Lucentis “which provides another option for patients and their clinicians to treat this sight-threatening condition”.

While Lucentis is listed on the Pharmaceutical Benefits Scheme for several conditions including neovascular age-related macular degeneration and diabetic macular edema, it is not currently listed for PDR.

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