TARRYTOWN, N.Y. and BERLIN, Dec. 20, 2010 /PRNewswire-FirstCall/
— Regeneron Pharmaceuticals, Inc. (Nasdaq:
REGN) and Bayer HealthCare today announced positive top-line
results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the
COPERNICUS study, which is led by Regeneron, the first of two Phase
3 studies in patients with macular edema due to central retinal
vein occlusion (CRVO). In this trial, 56.1 percent of
patients receiving VEGF Trap-Eye 2 milligrams (mg) monthly gained
at least 15 letters of vision from baseline, compared to 12.3
percent of patients receiving sham injections (p<0.0001), the
primary endpoint of the study. Patients receiving VEGF
Trap-Eye 2mg monthly gained, on average, 17.3 letters of vision
compared to a mean loss of 4.0 letters with sham injections
(p<0.001), a secondary endpoint. The second Phase 3 study,
GALILEO, is currently ongoing and is led by Bayer HealthCare.
VEGF Trap-Eye was generally well tolerated and the most common
adverse events were those typically associated with intravitreal
injections or the underlying disease. A total of 114 patients
were randomized to receive VEGF Trap-Eye and 73 patients to the
control arm. Serious ocular adverse events in the VEGF
Trap-Eye group were uncommon (3.5%) and were more frequent in the
control group (13.5%). The incidence of non-ocular serious
adverse events was generally well-balanced between the treatment
arms. There were no deaths among the 114 patients treated
with VEGF Trap-Eye and two in the 73 (2.7%) patients treated with
sham injections.
“In the COPERNICUS trial, patients treated with VEGF Trap-Eye
experienced a marked improvement in vision,” said George D.
Yancopoulos, M.D., Ph.D., President of Regeneron Research
Laboratories. “If these results are confirmed by data from
the GALILEO study, expected in the second quarter of 2
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