Eylea approval for wet AMD
pharmafile | November 29, 2012 | News story | Sales and Marketing | Bayer, Eylea, Lucentis, Novartis, avastin, wet AMD
Bayer HealthCare’s Eylea has been appoved in Europe for the treatment of neovascular age-related macular degeneration (wet AMD).
The eye condition is the leading cause of blindness for people aged over 65 in Europe, and involves new blood vessels growing beneath the retina and leaking blood and fluid.
The European Commission has authorised Eylea (aflibercept solution for injection) at a recommended dose of 2mg, with injections every other month – a crucial improvement in convenience for patients – after three monthly ones to start with.
Current treatments include Novartis’ monthly injection Lucentis (ranibizumab), which has been under pressure from Roche’s Avastin, even though Avastin is not licensed in this therapy area.
The green light for Eylea – previously known as VEGF Trap-Eye – is based on positive results from two Phase III trials. VIEW 1 and VIEW 2 showed various doses, including the 2mg one, were as good as the standard 0.5mg monthly injection of Lucentis.
Bayer has developed Eylea with Regeneron, the latter holding exclusive US rights while Bayer has the rights for every other country.
Both companies share profits equally – except in Japan, where the drug is soon to be launched and Regeneron will receive a royalty on net sales. Analysts have predicted Eylea could hit peak sales of $2 billion.
It is thought that over 80% of visual impairment from conditions such as wet AMD is preventable, which makes extra indications potentially lucrative.
Bayer says Phase III trials have been completed with Eyelea in macular edema following central retinal vein occlusion (CRVO), and are ongoing in diabetic macular edema (DME) and myopic choroidal neovascularization (mCNV).
The manufacturer plans to submit the brand in Europe in the next month for macular edema following CRVO.
Adam Hil
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