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Phase III trial of Bayer and Regeneron's eye drug begins in China

VEGF-Trap-Eye (aflibercept) drug candidate to be studied in patients with wet age-related macular degeneration (AMD)

Bayer and Regeneron have initiated a phase III trial in China of their VEGF-Trap-Eye (aflibercept) drug candidate in patients with wet age-related macular degeneration (AMD).

"Currently, only photodynamic therapy with verteporfin is approved as a treatment for wet AMD in China," said Bayer's head of global development Kemal Malik, who notes this regimen is only approved for a subpopulation of  wet AMD patients.

The Chinese study, called SIGHT, will enrol around 300 patients and once complete will be the largest retinal trial ever conducted in China, according to Bayer, which has marketing rights to aflibercept outside the US. It will evaluate a monthly loading dose of the drug, followed by maintenance doses every eight weeks.

Regeneron won approval for aflibercept as a treatment for wet AMD in the US, where it will be sold as Eylea, just a few days ago. The company said it would launch the product this week.

The US go-ahead was based on two pivotal trials - VIEW 1 and VIEW 2 - which showed that Eylea given every eight weeks after an initial loading regimen was equivalent to Roche's anti-VEGF drug Lucentis (ranibizumab), the current standard of care for wet AMD which is injected every four weeks.

The reduced dosing frequency and patient monitoring demand means that Eylea bypasses the need for monthly doctor visits for wet AMD patients.

"After reporting positive data from our large VIEW program in wet AMD, we look forward to potentially bringing this new treatment to patients with wet AMD in China," said Malik.

Lucentis was launched in 2006 and remains the only approved drug to treat the condition in the US, reaping in sales of $2.9bn last year, although Roche/Genentech's Avastin (bevacizumab) is also being used off-label in AMD. 

Eylea has been launched at a modest discount to Lucentis, and Regeneron is also due to report data from a head-to-head trial of the two therapies in the coming weeks.

Analysts have estimated that Eylea could achieve over $100m in sales in 2012 - its first full-year on the market - with peak sales well in excess of $1bn. Avastin could be the joker in the pack, however, as it is priced well below Lucentis and Eylea and comparative clinical data has started to be generated to support its use.

In July, a two-year study reported by the US National Institutes of Health found that Avastin and Lucentis were equally effective in treating AMD.

28th November 2011

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