(Adds details about Eylea, study findings, share price)
By Ransdell Pierson
Oct 21 Regeneron Pharmaceuticals Inc
said its drug Eylea improved vision in a late-stage trial far
better than standard laser treatment among patients with a
common form of vision loss caused by blood clots in secondary
veins of the retina.
Eylea has become a blockbuster product since winning U.S.
approval in November 2011 to treat the "wet" form of age-related
macular degeneration, a leading cause of blindness in which
leaky blood vessels in the central part of the retina can
The injectable drug is also approved for macular edema -
meaning fluid buildup under the central area of the retina -
that occurs after central retinal vein occlusion, which is
blockage of the retina's major vein. Both macular edema and
retinal vein occlusion can cause vision loss.
Regeneron on Monday described results from a Phase III study
called Vibrant, which tested 183 patients with macular edema
following branch retinal vein occlusion, meaning blockages
within branches of the central retinal vein. Such blockages can
cause blood and fluid to back up and spill into the retina.
Some 53 percent of the patients who received Eylea
injections every four weeks for 24 weeks gained at least 15
letters in vision, an eye chart test measuring sharpness of
vision. That was deemed better by a highly statistical margin
than the 27 percent of patients who achieved such vision gains
with standard laser treatment.
Laser treatment cauterizes leaky blood vessels in the eye,
to stop the leakage that leads to vision loss.
The company said 9.9 percent of patients in the Eylea group
experienced serious adverse events, compared with 9.8 percent in
the laser group.
There was one serious adverse event in a patient receiving
Eylea, Regeneron said. The patient suffered from a traumatic
cataract, a cataract which is related to eye injury.
Regeneron said common adverse events were bleeding from
broken blood vessels in the eye and pain in the eye.
Based on results of the Vibrant study, Regeneron said it
plans within several months to seek U.S. approval to market
Eylea for treatment of macular edema following branch retinal
Eylea in previous trials has also been shown to be
significantly better than laser treatment at improving vision in
diabetics who have macular edema.
Regeneron shares were down 1.4 percent at $299.30 on Monday
morning on the Nasdaq, amid slight declines for the drug sector.
The company has U.S. rights to Eylea, and equally shares
profit from the drug outside the United States with longtime
partner Bayer AG.
U.S. sales of Eylea rose 70 percent in the second quarter to
$330 million. Regeneron expects the drug to garner full-year
sales of up to $1.35 billion. Eylea has been steadily grabbing
market share from Roche Holding's similar drug,
(Reporting by Ransdell Pierson in New York; additional
reporting by Vrinda Manocha in Bangalore; editing by Sriraj
Kalluvila and Matthew Lewis)