Eylea beats rivals in government-sponsored head-to-head trial

Results from a trial comparing three treatments for serious eye disease have shown that Regeneron and Bayer's Eylea is the most effective.

The trial was sponsored by the US government-funded National Institutes of Health (NIH) and the Diabetic Retinopathy Clinical Research Network, and compared Eylea versus Novartis' rival treatment Lucentis, and Roche's Avastin.

The trial came about because of extensive off-label prescribing of Avastin against eye diseases such as age-related macular degeneration (AMD) and Diabetic Macular Oedema by ophthalmologists, because of its much lower cost than Lucentis.

The latest data consolidates the superior profile of Eylea, first confirmed in an earlier release of data from the NIH trial last October.

The trial will help Regeneron and Bayer seize more share from Novartis' market leader Lucentis, sales of which rose 5 per cent in 2014 to $2.44 billion.

The comparative effectiveness study in patients with Diabetic Macular Oedema (Protocol T) was published in the New England Journal of Medicine and a corresponding slide set was posted online at DRCR.net. Eylea (aflibercept) Injection demonstrated significantly greater improvement on the primary endpoint of mean visual acuity letter score change at one year [Eylea +13 letters; bevacizumab (Avastin) +10; ranibizumab (Lucentis) +11].

"In this independent, government-sponsored diabetic macular oedema study, Eylea provided significantly greater efficacy, despite one fewer injection and fewer laser treatments than comparators," said George D Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories. "The improvements with Eylea relative to alternative anti-VEGF therapies were particularly apparent in the group with moderate or worse vision loss at the start of the trial, where there was a greater opportunity to demonstrate gains in vision."

Italy dispute

The new NIH study adds further fuel to the controversy surrounding the therapy area, specifically the off-label use of Avastin.

Last week Europe's pharmaceutical industry organisation EFPIA launched a complaint against moves in Italy to allow off-label prescribing of Avastin to treat AMD. EFPIA, along with the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European association for bio-industries (EuropaBio) says Italy's regulations "infringe and undermine the European Union's marketing authorisation system," and therefore also pose a risk to patient safety.

The group also says the actions go against against a European Court of Justice ruling which indicated that EU countries may not use off-label prescribing as a cost-containment measure in cases where approved alternatives exist.