Eylea trial boost in DME
pharmafile | August 7, 2013 | News story | Research and Development, Sales and Marketing | Bayer, DME, Eylea, regenenron
The rival treatment to Novartis’ Lucentis has posted encouraging new study results in patients with diabetic macular oedema (DME).
In two Phase III studies for the treatment of DME, Regeneron and Bayer’s Eylea (aflibercept) achieved its primary endpoint of a significantly greater improvement in best-corrected visual acuity from baseline, compared to laser photocoagulation at 52 weeks.
Regeneron which owns rights to the drug in the US, says it now expects to submit an application for marketing approval in the country for the treatment of DME in 2013 – a year ahead of the previously announced timeline.
Bayer which markets the drug outside the US, also plans to submit an application for DME in Europe in this year.
Eylea was approved in the US for the treatment of wet age-related macular degeneration (AMD) in November 2011, and for macular oedema following central retinal vein occlusion (CRVO) in September 2012.
It is competing with Novartis’ Lucentis (ranibizumab) which also has licences for wet AMD and CRVO, as well as for DME. The drug which was first approved in 2006 made sales of over $1 billion last year.
“We are pleased with these positive data in another potentially important indication for Eylea,” said George Yancopoulos, chief scientific officer of Regeneron. “Diabetes is a growing disease worldwide and DME is a major cause of vision loss in people with diabetic retinopathy. We hope to be able to offer a new treatment option for patients suffering from this potentially blinding retinal disease.”
Eylea sales stalls
Alongside the release of these new data, Regeneron also posted its second quarter earnings this week, which showed that sales of its new drug have begun to slow as dosing regimens become less frequent.
US sales of the drug rose 70% in the second quarter to $330 million, but this has slowed from the 153% growth achieved in the first quarter.
“As the dosing interval increases, the number of doses per quarter do decline, so we’re dependent on getting new patients into the marketplace,” explained Regeneron’s chief executive Leonard Schleifer in a conference call with analysts.
Eylea is introduced by injection into the eye every four weeks for the first three months, and then is subsequently only administered every two months.
But the company raised its 2013 sales estimate for Eylea to between $1.3 billion and $1.35 billion, up from its earlier estimate of $1.25 billion to $1.33 billion, meaning it still sees its new treatment as a growth driver.
Ben Adams
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