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HomeminewsEylea Studies Prove it for AMD: Same Results, Fewer Injections

Eylea Studies Prove it for AMD: Same Results, Fewer Injections

24 October was a day that will go down in history for Bayer in Australia.

The company released positive results from a large global study (View 1 & 2) into the ability of Eylea (Aflibercept) to treat Neovascular (wet) Age Related Macular Degeneration (AMD). And, the government announced that from 1 December 2012, Eylea will be listed on the Pharmaceutical Benefits Scheme (PBS) for use by both new and existing patients.

The government’s decision is significant. In March, Eylea was approved as a treatment for new patients with Wet AMD. Patients currently being treated with Ranibizumab – which is commercially marketed as Lucentis – and/or Avastin – were unable to be switched to Eylea, which according to studies, requires fewer injections to keep the disease progression at bay.

This most recent decision from the government 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 announced that from 1 December 2012, Eylea will be listed on the Pharmaceutical Benefits Scheme (PBS) for use by both new and existing patients

View 1 & 2 Results Revealed

According to clinical data from the View 1 and View 2 studies, which was presented to ophthalmologists at an interactive evening meeting in Sydney, Melbourne, Adelaide and Brisbane in 24 October, Aflibercept is as effective as Ranibizumab in halting and even reversing the effect of wet Macular Degeneration.

Furthermore, in US post-marketing experience, some patients with sub optimal results to treatment with Ranibizumab have responded to treatment from Aflibercept.

The View 1 and View 2 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.

Professor Mitchell, detailed the research criteria and findings to attendees at the Bayer meeting. In summarising the data he 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.

Professor Mitchell added that there were no unexpected significant ocular or non ocular adverse effects from either treatment.

The meeting crossed to a live presentation from Dr. Jeffrey Heier, MD, a Vitreoretinal Specialist, and Director of Vitreoretinal Service at Ophthalmic Consultants of Boston. Dr. Heier, who 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, and diagnostic imaging of the retina, spoke about his experiences treating patients with Eylea over the past 12 months.

Dr. Heier said he has had significant success when treating patients with Eylea. He said that of 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.

An Ability to Trap VEGF

At the meeting, attendees heard from Professor Robyn Guymer, Consultant Ophthalmologist – Medical Retial Unit at the Royal Victorian Eye and Ear Hospital. Dr. Guymer described the molecular design and mode of action of Aflibercept, which she said is unlike Ranibizumab, because it is designed to ‘trap’ Vascular Endothelial Growth Factor (VEGF).

Prof. Guymer acknowledged the assistance of the Macular Degeneration Foundation and ophthalmologists in lobbying the Government to approve Eylea for new and existing people with macular degeneration.

The 180 attendees at the evening meetings in Sydney, Adelaide, Brisbane and Melbourne heard that the cost of treatment with Eylea will be exactly the same as the treatment using Lucentis. The treatment will be available in Australia from December 1.