TARRYTOWN, N.Y. and BERLIN, June 7, 2011 /PRNewswire/ —
Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) and Bayer HealthCare today announced that Bayer
HealthCare has submitted an application for marketing authorization
in Europe for VEGF Trap-Eye for the treatment of the neovascular
form of age-related macular degeneration (wet AMD). Regeneron and
Bayer HealthCare are collaborating on the global development of
VEGF Trap-Eye for the treatment of wet AMD, central retinal vein
occlusion (CRVO), diabetic macular edema (DME), and myopic
choroidal neovascularization (mCNV).
“The submission of VEGF Trap-Eye for EU marketing authorization
represents a significant milestone in our goal to bring this
potentially important new therapy to patients with wet AMD across
the globe,” said Leonard S. Schleifer, M.D., Ph.D., President and
Chief Executive Officer of Regeneron.
The VEGF Trap-Eye submission is based on the positive results
from two Phase 3 trials, the VIEW 1 study and the VIEW 2 study.
In these trials, all regimens of VEGF Trap-Eye, including 2
mg VEGF Trap-Eye dosed every two months (following three loading
doses), successfully met the primary endpoint of non-inferiority,
compared to the current standard of care, ranibizumab 0.5 mg dosed
every month. The primary endpoint analysis was statistical
non-inferiority in the proportion of patients who maintained (or
improved) vision over 52 weeks compared to ranibizumab at the dose
that is currently known to provide the best possible efficacy.
A generally favorable safety profile was observed for both
VEGF Trap-Eye and ranibizumab. The ocular adverse events were
balanced across all treatment groups in both studies. There
were no notable differences in non-ocular adverse events among the
Regeneron submitted a Biologics License Application (BLA) for
marketing approval in wet