20 Feb 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Regeneron Pharmaceuticals and Bayer HealthCare have initiated a new phase III trial (named Vivid East-DME) to evaluate the efficacy and safety of Eylea (aflibercept) Injection in the treatment of Diabetic Macular Edema (DME) in Russia, China, and other Asian countries.
The companies are extending their global development program for Eylea in DME after promising results in the global phase II DME program.
"DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes and represents a significant unmet medical need, especially in China, where currently the only therapy for DME is macular laser photocoagulation," said Mr Kemal Malik , member of the Bayer HealthCare executive committee and head of global development. "With this new trial, we look forward to potentially bringing another treatment option to patients with DME in Asia and Russia."
Eylea was approved in the US 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. In Japan Eylea was approved for use in wet AMD in September 2012. Eylea was also approved in Europe, Australia, and in several other countries for use in wet AMD last year.
Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the US. Bayer HealthCare licensed the exclusive marketing rights outside the US, where the companies will share equally the profits from any future sales of Eylea, except for Japan where Regeneron will receive a royalty on net sales.