TARRYTOWN, N.Y. and BERLIN, April 8, 2011 /PRNewswire/ —
Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) and Bayer HealthCare today announced that they have
initiated the first of two Phase 3 clinical trials evaluating the
efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic
solution), an investigational new agent for the treatment of
certain eye diseases, in the treatment of Diabetic Macular Edema
(DME). The companies are extending their development program
for VEGF Trap-Eye in DME after promising results in the global
Phase 2 DME program.
The first Phase 3 trial in DME, named VIVID-DME, is being led by
Bayer HealthCare and has started in Australia. The trial will
also be conducted in Europe and Japan. A second study led by
Regeneron, named 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 Dr. Kemal
Malik, Head of Global Development and member of the Bayer
HealthCare Executive Committee. “After reporting positive
results from our global Phase 3 program (VIEW 1 and VIEW 2 studies)
for the treatment of the neovascular form of age-related macular
degeneration (wet AMD), 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.”
The Phase 3 program in DME expands the companies’ global
development collaboration for VEGF Trap-Eye. The companies
announced positive data for two Phase 3 studies in patients with
wet AMD in November 2010 and for the first of two Phase 3 studies
in patients with Central Retinal Vein Occlusion (CRVO) in December
2010.
About the Phase 3 DME Program
The VIVID-DME study (VEGF Trap-Eye In
Vision Impairmen
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