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HomeminewsEylea Now PBS Listed to Treat All Wet AMD Patients

Eylea Now PBS Listed to Treat All Wet AMD Patients

The Federal Government has announced that from 1 December 2012, Eylea (Aflibercept) will be listed on the Pharmaceutical Benefits Scheme (PBS) for use by both new and existing patients.

This makes Australia the first country in the world to make Eylea a government funded pharmaceutical for the treatment of wet Age Related Macular Degeneration.

The government’s decision is significant. In March, Eylea was approved as a treatment for new patients with Wet AMD, but patients currently being treated with Ranibizumab – which is commercially marketed as Lucentis – and/or Avastin – were unable to be switched to Eylea.

In large scale global studies (View 1 & 2), Eylea has been shown to achieve the same results as Ranibizumab when treating for Neovascular (wet) Age Related Macular Degeneration (AMD). However, Eylea requires fewer injections and therefore is an easier treatment program for patients with AMD to follow.

The Macular Degeneration Foundation has welcomed the government’s decision

The Macular Degeneration Foundation has welcomed the government’s decision. “The Government’s decision on extending listings for Macular Degeneration medicines, which will enable switching between drugs, is a very welcome one,” said Macular Degeneration Foundation CEO, Julie Heraghty.

“This will mean that ophthalmologists have the option to now assess patients for the most appropriate drug on an individualised basis to ensure the best outcome for the patient.”

“Most importantly, for some patients, this decision will mean fewer injections for the treatment of wet Age-related Macular Degeneration, lessening the burden of treatment for the patient, their carers and family,” said Ms. Heraghty.

View 1 and 2 Results

Clinical data from the View 1 and View 2 studies were revealed at an interactive evening meeting for ophthalmologists, hosted by Bayer in October. Professor Paul Mitchell told attendees the studies followed 2,412 patients and compared responses to treatment with Ranibizumab against treatment with Aflibercept. The View 1 study followed patients in America. View 2 followed patients in Europe, Asia Pacific and Latin America. It included 50 patients in Australia.

Patients being treated with Aflibercept were given 2mg dosage every eight weeks. Patients treated with Ranibizumab were given 0.5mg every four weeks.

In summarising the data, Professor Mitchell said there were no significant differences between the outcomes across the two treatment groups. He said 32 per cent of patients treated with Ranibizumab compared to 31 per cent of patients treated with Aflibercept gained three lines of vision after treatment. Both groups experienced a similar reduction in Central Retinal Thickness.

He said there were no unexpected significant ocular or non-ocular adverse effects from either treatment.

The meeting crossed to Dr. Jeffrey Heier, MD, a Vitreoretinal Specialist, and Director of Vitreoretinal Service at Ophthalmic Consultants of Boston. Dr. Heier is described as one of America’s leading clinical researchers for new treatments in exudative and non-exudative macular degeneration, diabetic macular edema, venous occlusive disease, vitreoretinal surgical techniques and instrumentation. He told attendees that in US post-marketing experience, some patients with sub optimal results to treatment with Ranibizumab have responded to treatment from Aflibercept.

Dr. Heier said that in his experience of treating 155 sub-optimal responders to Ranibizumab, 79 per cent had responded positively to Aflibercept. He said the patients treated had advanced stages of neo vascular macular degeneration, and while fluid levels had decreased, visual acuity did not improve.

Eylea is available in Australia from 1 December 2012.