Regeneron Says Retinal Treatment Trials Met Primary Endpoints
09 September 2022 - 12:19AM
Dow Jones News
By Dean Seal
Regeneron Pharmaceuticals Inc. said Thursday that two pivotal
trials for its diabetic macular edema and wet age-related macular
degeneration treatment met their primary endpoints.
The company said 12- and 16-week dosing regimens for the
eight-milligram formulation of its aflibercept treatment showed
non-inferiority in vision gains compared with an eight-week dosing
regimen of its Eylea injection treatment.
The safety of the eight-milligram aflibercept is consistent with
the established safety profile of Eylea, Regeneron said.
The novel formulation is being jointly developed with Bayer AG.
The two companies will now submit the trial data to regulators in
countries around the world.
"These unprecedented durability data coupled with a safety
profile consistent with that of EYLEA support aflibercept 8 mg as a
potential new standard-of-care in these diseases," said David
Brown, director of research at Retina Consultants of Texas in the
U.S. and a trial investigator.
Shares were halted ahead of the news and remained halted at
$596.44 when the market opened Thursday.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
September 08, 2022 10:04 ET (14:04 GMT)
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