Regeneron, Bayer commence phase-3 trial for diabetic macular edema treatment

TARRYTOWN, N.Y. and BERLIN — Regeneron and Bayer HealthCare have initiated 1-of-2 late-stage clinical trials of their aflibercept ophthalmic solution in the treatment of a complication caused by diabetic retinopathy.

The drug makers said that it would evaluate the efficacy of VEGF Trap-Eye (aflibercept ophthalmic solution) in the treatment of diabetic macular edema, a prevalent cause of vision loss among diabetes patients, after promising results from its previous clinical trial.

The first phase-3 trial, VIVID-DME, being led by Bayer HealthCare, has commenced in Australia and also will be conducted in Europe and Japan. A second study led by Regeneron, VISTA-DME, is expected to begin later in 2011 in the United States, Canada and other countries.

"Clinically significant DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes," said Kemal Malik, head of global development and member of the Bayer HealthCare executive committee. "We are pleased to start a phase-3 program with VEGF Trap-Eye in DME, which may help to address this significant unmet medical need."