Eylea receives new European approval
pharmafile | August 30, 2013 | News story | Research and Development, Sales and Marketing | Bayer, CRVO, Eylea, Lucentis, Novartis, wet AMD
Bayer and Regeneron’s Eylea has been approved in Europe to treat visual impairment due to macular oedema following central retinal vein occlusion (CRVO).
The new indication means Eylea (aflibercept) will continue to challenge another vascular endothelial growth factor (VEGF) eye trap, Novartis’ established eye drug Lucentis (ranibizumab).
Analysts predict peak sales of $2 billion per year for Eylea, co-developed by Bayer (which has rights to the drug outside the US) and Regeneron (which has US exclusivity).
It is already authorised to treat wet age-related macular degeneration (AMD) in European Union countries – and has both licenses in the US, gaining the most recent in September last year.
Trials suggest that anti-VEGF treatment may help decrease vascular permeability and oedema in the retina in patients with CRVO, a condition causing retinal damage and loss of vision.
“The results of the two Phase III studies were encouraging with the majority of patients with macular oedema secondary to CRVO experiencing a significant improvement in visual acuity with Eylea,” said Frank Holz, professor in the University of Bonn’s Department of Ophthalmology, and lead principal investigator of the GALILEO trial.
CRVO, caused by obstruction of the central retinal vein that leads to an accumulation of deoxygenated blood and fluid in the retina, affects more than 66,000 people in Europe and over 100,000 in the US.
Kemal Malik, head of global development for Bayer, called the new indication ‘great news’ for sufferers in Europe. “The loss of vision from macular edema secondary to CRVO not only impacts patients but also their families’ lives,” he added.
Lucentis, which was first approved in 2006 and made sales of over $1 billion last year, also has a licence to treat diabetic macular oedema (DME) – an indication that Bayer is keen to emulate and which may well be next on its list for approval.
The German firm has released encouraging results for Eylea in DME, with the drug achieving its primary endpoint in two Phase III studies: a significantly greater improvement in best-corrected visual acuity from baseline, compared to laser photocoagulation at 52 weeks.
The company has also completed Phase III trials of the treatment in myopic choroidal neovascularization (mCNV).
Bayer and Regeneron share equally the profits from sales of Eylea – except in Japan where Regeneron gets a royalty on net sales.
Adam Hill
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