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Regeneron, Bayer initiate DME drug Phase 3 trial

Regeneron and Bayer have commenced first of two Phase 3 clinical trials in Australia, investigating the safety and efficacy of an experimental new agent to treat certain eye diseases, in the treatment of diabetic macular edema (DME), VEGF Trap-Eye (aflibercept ophthalmic solution).

Led by Bayer Healthcare, the first Phase 3 trial VIVID-DME, in DME is also expected to be organized in Europe and Japan.

However, the second trial will be led by Regeneron in the US, Canada, and other countries, and is expected to be start in late 2011.

Bayer HealthCare Executive Committee Global Development head Kemal Malik said after reporting positive results from the global Phase 3 program (VIEW 1 and VIEW 2 studies) for the treatment of the neovascular form of age-related macular degeneration (wet AMD), they are pleased to start a Phase 3 program with VEGF Trap-Eye in DME which may help to address this significant unmet medical need.