Bayer and Regeneron report positive Phase III VIVID-DME trial results of Eylea

21st July 2014 (Last Updated July 21st, 2014 18:30)

Bayer HealthCare and Regeneron Pharmaceuticals have reported positive results from the Phase III VIVID-DME trial of Eylea (aflibercept) injection for treatment of diabetic macular edema (DME).

Bayer HealthCare and Regeneron Pharmaceuticals have reported positive results from the Phase III VIVID-DME trial of Eylea (aflibercept) injection for treatment of diabetic macular edema (DME).

In the VIVID-DME trial, patients were randomised to receive either Eylea injection into the eye every month (n=136), Eylea injection every two months (n=135), or the comparator treatment of laser photocoagulation (n=132).

The trial showed that Eylea 2mg in both treatment groups showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100, compared with laser photocoagulation.

Patients receiving Eylea injection every month had a mean gain from baseline in BCVA of 11.4 letters, while those receiving it every two months had a mean gain from baseline in BCVA of 9.4 letters.

"The trial showed that Eylea 2mg in both treatment groups showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100, compared with laser photocoagulation."

Individuals in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.7 letters.

In addition, 31.1% of patients receiving Eylea injection 2mg every two months achieved an increase of greater than or equal to 15 letters, a gain of three lines from baseline as one of the endpoints compared to the laser treatment group with only 12% achieving a similar gain.

In the trial, Eylea had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the Eylea treatment groups and the laser control group.

Regeneron chief scientific officer and Regeneron Laboratories president George Yancopoulos said: "These data showed that treatment with Eylea in this trial improved vision and maintained the improvement over two years in patients with diabetic macular edema."

In the US, EYLEA was approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) in November 2011 and for macular edema following central retinal vein occlusion (CRVO) in September 2012.

The drug has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO.

Bayer and Regeneron are collaborating on the global development of Eylea, with Regeneron maintaining exclusive rights of the drug in the US and Bayer having exclusive marketing rights outside the US.